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Acta Anaesthesiol Scand 2009; 53: 354–363
Printed in Singapore. All rights reserved
r 2009 The Authors
Journal compilation r 2009 The Acta Anaesthesiologica Scandinavica Foundation
ACTA ANAESTHESIOLOGICA SCANDINAVICA
doi: 10.1111/j.1399-6576.2008.01874.x
Procedure-related pain among adult patients with
hematologic malignancies
Y. LIDÉN1, O. LANDGREN2,3, S. ARNÉR1, K.-F. SJÖLUND1 and E. JOHANSSON2
1
Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden,
Department of Medicine, Division of Hematology, Karolinska University Hospital and Institutet, Stockholm, Sweden and 3National Cancer
Institute, National Institutes of Health, Bethesda, MD, USA
2
Background: Cancer patients undergo numerous invasive
diagnostic procedures. However, there are only sparse
data on the characteristics and determinants for procedure-related pain among adult cancer patients.
Methods: In this prospective study, we evaluated the
characteristics and determinants of procedure-related
pain in 235 consecutive hematologic patients (M/F:126/
109; median age 62 years, range 20–89 years) undergoing
a bone marrow aspiration/biopsy (BMA) under local
anesthesia. Questionnaires were used to assess patients
before-, 10 min and 1–7 days post BMA. Using logistic
regression models, we calculated odds ratios (ORs) and
95% confidence intervals (CIs).
Results: 165/235 (70%) patients reported pain during BMA; 92
(56%), 53 (32%) and 5 (3%) of these indicated moderate [visual
analogue scale (VAS) 30 mm], severe (VAS454 mm) and
worst possible pain (VAS 5 100 mm), respectively. On multivariate analyses, pre-existing pain (OR 5 2.60 95% CI 1.26–5.36),
anxiety about the diagnostic outcome of BMA (OR 5 3.17 95%
CI 1.54–6.52), anxiety about needle-insertion (OR 5 2.49 95% CI
1.22–5.10) and low employment status (sick-leave/unemployed) (OR 5 3.14 95% CI 1.31–7.55) were independently
associated with an increased risk of pain during BMA. At
follow-up 10 min after BMA, 40/235 (17%) patients reported
pain. At 1, 3, 6 and 7 days post BMA, pain was present in 137
(64%), 90 (42%), 43 (20%) and 25 (12%) patients, respectively.
Conclusions: We found that 3/4 of hematologic patients who
underwent BMA reported procedural pain; one third of these
patients indicated severe pain. Pre-existing pain, anxiety about
the diagnostic outcome of BMA or needle-insertion, and low
employment status were independent risk factors.
T
have also been reported to trigger long-lasting
pain.
Cancer patients are frequently exposed to various invasive diagnostic procedures during the
initial work-up and during the course of illness.
Previous studies focusing on childhood cancer
have shown that children fear medical procedures13 and that procedure-related pain is difficult
to alleviate, even more difficult than cancer-related
pain.14,15 Conversely, few studies have assessed
procedure-related pain and particularly the factors
associated with procedure-related pain in adult
patients with cancer (Table 1).16–22
To increase our understanding on the characteristics and determinants of procedure-related pain
among adult patients with cancer, we have conducted a large and comprehensive prospective
study focusing on hematologic patients who
HE prevalence of pain in patients with cancer,
regardless of the stage of the disease, has been
found to be substantially higher than the general
population.1–3 Indeed, pain is one of the major
distressing symptoms in patients with a malignant
disease.4,5 Anxiety is also common in people when
diagnosed with cancer.6 In cancer patients, as well
as in non-cancer patients, it is well known that
pre-existing pain often amplifies the pain experience after surgery7 and that pain perception can be
intensified if accompanied by anxiety.8,9 Furthermore, surgery10,11 and diagnostic procedures12
Disclosure of previous presentations: The results have previously been
presented in part as an abstract at two conferences: the IASP
11thWorld Congress on Pain, Sydney, Australia, and the 5th World
Congress of the European Federation of IASP Chapters, Istanbul,
Turkey.
354
Accepted for publication 1 November 2008
r 2009 The Authors
Journal compilation r 2009 The Acta Anaesthesiologica Scandinavica Foundation
Procedure-related pain and cancer
Table 1
Pain during invasive diagnostic procedures in patients with cancer
Authors
(reference)
No. of
patients
Type of
procedure
Anesthetic
Groups
Pain frequency
Pain on VAS (SD)
Brausi et al.
(2007)16
40
TUR of
bladder
tumor
Lidocaine
Brennan et al.
(2007)17
100
(50150)
FNAC of
head and
neck mass
Unknown
21G
23G
Mean VAS* 3.3
(1.94)
Mean VAS* 1.8
(1.1)
Daltrey et al.
(2000)18
98
FNAC of
breast mass
Lignocaine
Lignocaine 21G
Lignocaine 23G
without anaesthetic
21G
without anaesthetic
23G
Mean VAS* 3.0
Mean VAS* 2.1
Mean VAS* 5.1
60% VAS* 0–4
30% VAS* 4–6
10% VAS*46
Mean VAS* 2.9
Gursoy et al.
(2007)19
99
(50149)
FNAB of
thyroid
nodules
EMLA/placebo
EMLA
Placebo
82% pain
98% pain
Kilciler et al.
(2007)20
340
(1701170)
TRUS
guided
biopsy of
prostate
No
Lithotomy position
Left lateral decubitus
position
Kuball et al.
(2004)21
263
BMA
Mepivacaine
34% mild pain
39% moderate
pain
15% severe pain
5% very severe
pain
0.4% worst
possible pain
Vanhelleputte
et al. (2003)22
132
BMA
Lidocaine
84% pain
Mean VASw 25.0
(22.3)
Mean VASw 40.0
(30.5)
Mean VAS* 4.0
(1.93)
Mean VAS* 2.7
(1.56)
Mean VASw 27.2
*0–10 cm.
w0–100 mm.
TUR, transurethral resection; TRUS, transrectal ultrasonography; FNAC, fine-needle aspiration cytology; FNAB, fine-needle
aspiration biopsy; BMA, bone marrow aspiration/biopsy; G, gauge; VAS, visual analogue scale.
underwent a bone marrow aspiration/biopsy
(BMA) under local anesthesia.
Methods
Sample
The data collection periods were from May 1 to
June 30, 2004, and September 1 to October 30, 2004.
Two hundred thirty-five (median age 62 years,
range 20–89 years, Table 2) of 263 consecutive adult
patients who were scheduled for BMA at the outpatient clinic at Division of Hematology, Karolinska
University Hospital, were included. Patients could
only be enrolled once. Thirty-three patients were
excluded due to: difficulties in understanding the
Swedish language (n 5 13), unwillingness to participate (n 5 7), late arrival (n 5 5), sedative medication (n 5 2) or fainted (n 5 1) before BMA. Preexisting pain was present in 101 of included patients and 44 patients had taken pain medication
the same day as the BMA (Table 2). The study was
approved by the Regional Ethics Committee in
Stockholm.
Procedures
Patients were invited to participate in the study by
one of the authors (Y. L.). Informed consent was
obtained from all included patients before study
enrollment. Self-administered questionnaires were
used to collect data before and 10 min after the
355
Y. Lidén et al.
Table 2
Data collection
Characteristic of 235 patients undergoing BMA
Clinical information and measures of pain, discomfort and
anxiety. Using a standardized data entry form, the
Variable
Number of subjects, n (%)
235 (100)
Age, median years (range)
62 (20–89)
Gender, n (%)
Female
109 (46)
Male
126 (54)
Diagnosis according to BMA, n (%)
Leukemia
34 (14)
Multiple myeloma
39 (17)
Lymphoma
46 (19)
Myelodysplastic syndrome
18 (8)
Chronic myeloproliferative disorder
31 (13)
Other hematologic disease
42 (18)
Non-hematologic disease
25 (11)
Site of BMA, n (%)
Posterior iliac crest
230 (98)
Sternum
5 (2)
Type of BMA, n (%)
Bone marrow aspiration
67 (28)
Bone marrow biopsy
88 (37)
Both aspiration and biopsy
80 (35)
Previous BMA, n (%)
No previous BMA
100 (43)
1–2 times
76 (32)
3–5 times
27 (11)
45 times
32 (14)
Pre-existing pain, n (%)
101 (43)
Pain medication taken the same day as BMA, n (%)
Non-opioids
19 (8)
Opioids
8 (3)
Combination of non-opioids and opioids
6 (2)
Adjuvant drugs
3 (1)
Unknown type
8 (3)
BMA, bone marrow aspiration/biopsy.
BMA. The participants were also requested to
answer questions by telephone 1 week after BMA.
BMA. Nine attending hematologists and seven
hematology fellows performed 61 and 174 of the
BMAs, respectively. Individuals, who were scheduled for BMA for the first time, received mail with
written information about BMA procedures before
their visit. At the visit, all patients were informed
orally about the BMA procedure by the same
physician who performed the BMA. According to
the standard clinical praxis at Karolinska, no premedication were commonly used. As pain relief, a
local anesthetic (Lidocaine 1% 10–20 ml) was given
subcutaneously as well as through periostal infiltration. Five minutes after the local anesthetic was
administered, BMA was carried out using an aspiration needle 15 G 2.7 in. and/or a biopsy needle 11 G 4 in. (Medical Device Technologies Inc.
Gainesville, FL). A registered nurse was assisting
the physician.
356
physician performing the BMA noted predefined
clinical information regarding the patient. Using
questionnaires, we obtained self-reported information from the patients about presence/absence of
pain, discomfort and anxiety (the response options
were: yes/no). The intensities of pain, discomfort
and anxiety were measured with visual analogue
scales (VAS) ranging from 0 to 100 mm with one
statement in each range: 0 mm 5 no pain and
100 mm 5 worst possible pain, 0 mm 5 no discomfort and 100 mm 5 worst possible discomfort and
0 mm 5 no anxiety and 100 mm 5 worst possible
anxiety. The participants were requested to mark
the point at the line that best agreed with how the
pain, discomfort and anxiety were experienced.
The intensity of pain scored 430 mm on VAS was
considered to be equal to moderate pain and
VAS454 mm to be equal to severe pain.23
A study-specific questionnaire was used including questions concerning
height and weight, pain in daily life (pre-existing
pain), pain before BMA, whether pain medication
was taken the same day as BMA and anxiety about
the BMA needle-insertion and anxiety about the
diagnostic outcome of BMA. Questions regarding
pre-existing pain were adopted from the Karolinska Hospital Pain Questionnaire.12,24
Anxiety was measured with Stait Trait Anxiety
Inventory (STAI)25, which is a well-validated and
reliability-tested instrument.26 STAI is composed of
two forms, STAI-S and STAI-T, with 20-item scales
each. STAI-S measures the subject’s level or state of
anxiety at a particular moment in time, whereas
STAI-T refers to the trait or the general feelings of
anxiety-proneness. The total score for each form
has a range from 20 to 80 points; a higher score
indicates a higher level of anxiety.
Demographic data were collected with a questionnaire27 with items concerning sex, age, marital
status, foreign background, employment status,
education level and perceived economical status.
Questionnaires before BMA.
Ten minutes after
BMA, a study-specific questionnaire was administered including questions about: pain during BMA
and BMA-related pain 10 min after BMA, discomfort during BMA, satisfaction with the pain management, whether information about BMA was
Questionnaires 10 min after BMA.
received and whether the patient had undergone a
BMA previously.
One week after
BMA, an individual structured telephone interview
was conducted by one of the authors (Y. L.). The
patients were asked about the occurrence of BMArelated pain and pain intensity at 1, 3, 6 and 7 days
following BMA. The patients were also asked about
the use and type of medication for BMA-related pain.
Telephone interview 1 week after BMA.
Before the
start of the study, the study specific questionnaires
were revised by an expert group including attending
physicians and registered nurses specialized in hematology or pain management. Also, a group of 24
patients with prior experience of invasive medical
procedures were asked to comment on the clarity of
questions, resulting in changes in a few questions.
Testing of the study-specific questionnaires.
Statistics
Before the start of the study, a power analysis was
performed using a two-tailed w2 test. A difference
of 20% was considered as the smallest effect size of
clinical relevance to detect between the two variable groups: anxiety and pain during BMA vs. no
anxiety and pain during BMA. a was set to 0.05.
With a sample size of 93 persons in each group, the
study would have a power of 80% to yield a
statistically significant result. An attrition rate of
20% was estimated and an accrual of 233 patients
was planned.
Differences between groups were assessed with
the Mann–Whitney U-test or the Kruskal–Wallis
test. Proportions were compared with the w2 test.
Spearman’s rank-order correlation coefficients
were used to describe the relation between the
STAI-S score and VAS scores for anxiety. A positive
correlation coefficient between 0.10 and 0.29 was
regarded as small, between 0.30 and 0.49 as medium and between 0.50 and 1.00 as large.28
A forward stepwise logistic regression was applied to estimate the probability of occurrence of
pain during BMA. Univariate logistic regression
analyses were performed to select variables to be
tested for inclusion in the multivariate model. All
factors with a P-valueo0.05 were entered; see
Table 3. The a priori selected term sex was also
included. Estimated odds ratios (OR) with confidence intervals (CI) were calculated. The statistical
calculations were performed using of the software
Stat View 5.0.1 and SPSS 14.0.
Results
Procedure-related pain
Among study participants, 165 patients (70%) reported pain during BMA, with a median VAS of
Table 3
Association between potential predictive factors and occurrence of pain during BMA
Variable
Age*
o60 years
60 years
Sex*
Female
Male
Prior BMA*
Yes
No
Pre-existing pain*
Yes
No
Pain before BMA*
Yes
No
Anxiety about needle-insertion*
Yes
No
Anxiety about BMA result*
Yes
No
Received written information
No
Yes
P-value
Observation (n)
Pain during BMA rate, %
OR (95% CI)
108
127
76.8
64.5
1.82 (1.02–3.24)
0.041
109
126
76.2
65.1
1.71 (0.97–3.04)
0.064
100
135
75.6
63
1.82 (1.03–3.19)
0.038
101
132
78.2
63.6
2.05 (1.14–3.71)
0.017
69
164
82.6
64.6
2.60 (1.29–5.23)
0.007
126
109
82.5
56
3.72 (2.05–6.75)
o0.001
147
88
80.2
53.4
3.55 (1.98–6.36)
o0.001
143
90
70.6
70
1.03 (0.58–1.84)
0.918
357
Y. Lidén et al.
Table 3 Continued.
Received oral information
No
Yes
Pain medication taken same day as BMA
Yes
No
Body mass index
25
o25
BMA duration
15 min
o15 min
Experience of physician
100 BMA
4100 BMA
Education of physician
Hematology fellow
Attending hematologist
Type of BMA
Bone marrow biopsy
Economical situation
Bad
Either bad or good
Good
Marital status
Single
Divorced/separated
Married/cohabiting
Widow/widower
Foreign background
Yes
No
Employment status
Sick-leave or unemployed
Working or studying
Retired
Education level*
Highw
Intermediatez
Low§
Underlying diagnosis
Multiple myeloma
Lymphoma
Leukemia
Platelet count (109/l)
Hemoglobin level (g/l)
Total STAI S 10*,z, k
Total STAI T 10*,z,**
24
207
70.8
70.5
1.02 (0.4–2.57)
0.976
44
188
75
69.2
1.34 (0.63–2.83)
0.446
91
136
71.4
69.8
1.08 (0.60–1.94)
0.799
50
182
78
68
1.66 (0.79–3.48)
0.179
50
185
66
71.3
0.78 (0.40–1.52)
0.464
174
61
68.3
75.4
0.71 (0.36–1.37)
0.303
80
67
88
76.2
70.1
64.8
1.75 (0.89–3.43)
1.28 (0.65–2.53)
0.106
0.481
20
44
167
75
72.7
68.9
1.36 (0.47–3.93)
1.21 (0.58–2.53)
0.574
0.260
46
12
147
23
78.3
75
70.1
60.9
2.31 (0.78–6.90)
1.93 (0.41–9.10)
1.50 (0.61–3.73)
0.132
0.407
0.378
59
172
74.6
68.6
1.34 (0.69–2.62)
0.388
79
50
106
83.5
64.0
63.2
2.96 (1.45–6.03)
1.04 (0.51–2.08)
0.003
0.924
85
95
49
78.8
68.4
61.2
2.36 (1.09–5.12)
1.37 (0.67–2.82)
0.030
0.389
39
46
18
31
42
25
34
76.9
69.6
66.7
71.0
69.0
68.0
67.6
1.59
1.09
0.96
1.17
1.07
1.02
(0.57–4.49)
(0.42–2.84)
(0.28–3.22)
(0.41–3.36)
(0.40–2.82)
(0.34–3.07)
0.377
0.855
0.943
0.772
0.897
0.977
1.00
1.00
1.59
1.97
(0.99–1.00)
(0.99–1.01)
(1.22–2.05)
(1.29–3.01)
0.795
0.671
o0.001
0.002
The last category of each nominal variable was used as the reference category.
*Variables selected for multivariate model.
wUniversity/similar.
zUpper secondary school/similar.
§Primary school/similar or lower.
zTen units increments.
k Internal attrition; n 5 13.
**Internal attrition; n 5 19.
BMA, bone marrow aspiration/biopsy.
358
37 mm. In patients who reported BMA-related
pain, 92 patients (56%) indicated moderate pain
(VAS 30 mm), 53 patients (32%) reported severe
pain (VAS454 mm) and five patients (3%) experienced the worst possible pain (VAS 5 100 mm). At
follow-up 10 min after BMA, 40/235 (17%) patients
reported BMA-related pain with a median VAS of
31.5 mm (Fig. 1). At the subsequent follow-up 1, 3, 6
and 7 days post BMA, pain was present in 137
(64%), 90 (42%), 43 (20%) and 25 (12%) patients,
respectively, with a median VAS ranging between
15 and 30 mm (Fig. 1). Twenty of 64 patients (31%)
who did not report pain during BMA and 10 min
after BMA reported pain at least on one occasion 1–
7 days post BMA. There were no statistical differences in the clinical characteristics (including platelet counts) between patients who experienced an
immediate BMA-related pain and patients who
Pain intensity scored on VAS 1–100 mm
100
developed pain at day 1–7 (data not shown).
Sixty-two patients took pain medication due to
BMA-related pain on one or several occasions after
BMA (non-opioids n 5 49, opioids n 5 6, combination of non-opioids and opioids n 5 5, adjuvant
drugs and non-opioids n 5 2).
Procedure-related discomfort
Discomfort during BMA was reported by 137
patients (59%, VAS median 40 mm, range 2–
100 mm). Seventy four percent of patients who
reported BMA-related pain mentioned discomfort
during BMA compared with 21% of patients who
did not report BMA-related pain (Po0.0001). Patients reporting both pain and discomfort during
BMA reported a higher pain intensity compared
with patients who experienced pain but no discomfort (VAS median 42 mm vs. 25 mm, P 5 0.027).
Factors associated with procedure-related pain
80
60
40
20
0
At BMA
10 min
post BMA
1 day
3 days
post BMA post BMA
6 days
7 days
post BMA post BMA
Patients reporting BMA-related pain , n (%)
165 (70)
40 (17)
137 (64)
90 (42)
43 (20)
25 (12)
Fig. 1. Intensity of bone marrow aspiration (BMA)-related pain
during and after BMA in patients reporting occurrence of pain.
Data are presented as median visual analogue scale (VAS) with
25th and 75th percentile ranges in boxes. The whiskers represent
the 10th and 90th percentiles and dots are outliers. Internal
The association between occurrence of pain during
BMA and potential predictive factors is outlined in
Table 3. The variables that were significantly related to occurrence of BMA pain were younger age,
prior BMA, pre-existing pain, pain before BMA,
anxiety about the needle-insertion and the diagnostic outcome of BMA, high education level, low
employment status (sick-leave or unemployed),
and high STAI-S and STAI-T levels. A multivariate
logistic regression analysis was performed to assess the contribution of the significant variables
and the variable sex. We found that pre-existing
pain, anxiety about the needle-insertion, anxiety
about the diagnostic outcome of BMA and low
employment status (sick-leave or unemployed)
were significantly related to the likelihood of pain
during BMA (Table 4).
Pre-existing pain, anxiety about the needleinsertion, not received of written information about
Table 4
Predictors of pain during BMA
Variables
b
SE
Wald
df
OR (95% CI)
P-value
Pre-existing pain
Anxiety about needle-insertion
Anxiety about BMA result
Employment status
Retired vs. working or studying
Retired vs. sick-leave or unemployed
0.95
0.91
1.15
11.37
0.57
1.14
0.37
0.36
0.37
6.66
6.22
9.83
2.60 (1.26–5.36)
2.49 (1.22–5.10)
3.17 (1.54–6.52)
0.42
0.45
1.84
6.57
1
1
1
2
1
1
0.010
0.013
0.002
0.003
0.176
0.010
0.57 (0.25–1.29)
3.14 (1.31–7.55)
Competing non-significant variables see Table 3.
OR, odds ratio; CI, confidence interval; BMA, bone marrow aspiration/biopsy.
359
attrition: (a) n 5 7, (b) n 5 22.
Y. Lidén et al.
BMA, longer BMA duration and foreign background were factors associated with a higher pain
intensity during BMA (Table 5).
The mean STAI-S score for the total group of
patients was 43.3 (SD 12.9) and 42.0 for STAI-T (SD
8.06). Patients with pain during BMA scored higher
on STAI-S (45.3 vs. 38.5, P 5 0.0005) and STAI-T
(43.1 vs. 39.2, P 5 0.004). Anxiety about the diagnostic outcome of BMA was reported by 147 patients (63%, VAS median 52 mm), and anxiety
about the BMA needle-insertion by 126 patients
(54%, VAS median 50 mm). There was no significant difference between patients who had undergone BMA previously or not regarding anxiety
about the diagnostic outcome of BMA or needleinsertion or anxiety level measured with STAI-S. In
a sub-analysis, we found large correlation coefficients between the STAI-S score and the VAS value
for anxiety about the diagnostic outcome of BMA
(rs 5 0.587, Po0.0001) and the BMA needle-insertion (rs 5 0.562, Po0.0001).
Patient satisfaction
In total, 216 patients (93%) reported that they were
satisfied with the pain management (local anesthesia) during the procedure. Those patients who were
not satisfied with the local anesthesia and reported
pain during BMA (7%) scored a higher intensity of
pain compared with those patients who reported
pain and were satisfied with the local anesthesia
during BMA (VAS median; 80 vs. 30 mm,
P 5 0.0001).
Discussion
In this prospective study, designed to assess pain
experience among adult patients with hematologic
malignancies undergoing BMA under local anesthesia, we found that three out of four patients
experienced pain with a median VAS of 37 mm.
Among those patients who reported pain, one out
of three scored severe or worst possible pain. We
found pre-existing pain, anxiety about needle-insertion or BMA diagnostic outcome and low employment status (being on sick leave/unemployed)
to be independent risk factors associated with
procedure-related pain. This investigation provides
new important clinical insights, of value for health
care professionals involved in conducting invasive
diagnostic procedures or developing protocols
for minimizing procedure-related pain in cancer
patients.
360
Table 5
Association between variables and intensity of pain among
patients experiencing BMA-related pain
Variable
Pain
during
BMA (n)
Age
o60 years
83
60 years
82
Sex
Female
83
Male
82
Prior BMA
Yes
102
No
63
Pre-existing pain
Yes
79
No
84
Pain before BMA
Yes
57
No
106
Anxiety about needle-insertion
Yes
104
No
61
Anxiety about the result
Yes
118
No
47
Received written information
Yes
63
No
101
Received oral information
Yes
146
No
17
Pain medication taken same day
Yes
33
No
130
Body mass index
25
65
o25
95
BMA duration
15 min
39
o15 min
124
Experience of physician
100 BMA
33
4100 BMA
132
Education of physician
Hematology fellow 119
Attending
46
hematologist
Type of BMA
Both aspiration
61
and biopsy
Bone marrow
47
aspiration
Bone marrow
57
biopsy
Economical situation
Bad
15
Either good or bad
32
Good
115
Marital status
Single
36
Divorced/
103
separated
Married/
9
cohabiting
P-value*
VAS
Median
Range
37
38
3–100
3–100
0.582
39
34.5
4–100
3–100
0.398
42
30
3–100
3–100
0.080
45
26
3–100
3–100
0.022
42
29.5
3–100
3–100
0.163
45
25
3–100
3–100
0.0006
41
30
3–100
3–100
0.121
27
44
3–100
3–100
0.028
3–100
3–100
0.678
4–100
3–100
0.973
36
38
3–100
3–100
0.961
45
31
8–99
3–100
0.017
10–100
3–100
0.121
40
25
3–100
3–100
0.069
36
4–100
0.151
45
4–100
27
3–100
72
41
32
13–100
4–100
3–100
0.057
39
36
3–100
3–100
0.554
20
4–97
34
42
as BMA
36
37
45
33.5
Table 5 Continued
Widow/widower
Foreign background
Yes
No
Employment status
Sick-leave or
unemployed
Working or
studying
Retired
Education level
Highw
Intermediatez
Low§
Underlying diagnosis
Multiple myeloma
Lymphoma
Myelodysplastic
syndrome
Chronic
myeloproliferative
disorder
Other hematologic
disease
Non-hematologic
disease
Leukemia
14
49.5
4–100
44
118
45
28
4–100
3–100
0.008
66
30
3–100
0.072
32
46
67
40
10–95
3–100
67
65
30
27
40
47
3–99
3–100
4–100
0.328
30
32
12
39
40.5
19.5
3–100
3–100
8–100
0.739
22
42.5
4–98
29
27
5–100
17
42
4–99
23
42
4–78
*Statistical tests used; Mann–Whitney U test or Kruskal–Wallis
test.
wUniversity/similar.
zUpper secondary school/similar.
§Primary school/similar or lower.
BMA, bone marrow aspiration/biopsy; VAS, visual analogue
scale.
Consistent with results of prior studies investigating pain in adult cancer patients undergoing
procedures under local anesthesia (Table 1), a large
majority of our patients (70%) experienced pain
during BMA. Among patients reporting pain, 32%
scored severe pain and 3% worst possible pain,
which is in agreement with previous studies on
BMA-related pain where 16–33% of patients are
reported to suffer from severe pain.21,22,29 Procedural pain is often described as a temporary and
transient experience. This is one of the first studies
following procedural pain over time and, in our
patients, pain was present in 64% 1 day after BMA
and in 12% 1 week after BMA. The prolonged pain
duration may be due to local edema/bleeding.
However, the platelet count did not differ between
those who experienced pain after BMA and those
who did not. We have speculated on other potential
explanations of our findings. Physiological phenomena such as peripheral and central sensitization of the nervous system following the initial
nociceptive barrage could alternatively account for
a part of this observation.11,30
To improve our understanding on the potential
predictive factors for procedural pain, we assessed
the influence of several variables. On multivariate
analyses, we found pre-existing pain, anxiety about
the needle-insertion or BMA diagnostic outcome
and low employment status (being on sick-leave/
unemployed) to be associated with occurrence of
procedure-related pain. Pre-existing pain (44% of
patients) that is chronic pain was also related to the
experience of a higher intensity of pain. That is in
conformity with the increasing evidence that
chronic pain before surgery predicts increased
intensity of postoperative pain.7 The relationship
between past and present pain is suggested to be
influenced by emotional status, expectations of
pain and peak intensity of previous pain.31 A lower
pain threshold in patients with chronic pain has
furthermore been attributed to the fact that those
taking opioid medications for pain may develop a
tolerance, thereby requiring higher doses of analgesics.32,33 Because half of our patients had taken
pain medications the same day as the BMA, and
only a minority of those reported the use of
opioids, this explanation seems to have limited
impact in this context. Patients on sick-leave as
well as unemployed persons were more likely to
experience procedural pain. The finding concerning low employment status may reflect a more
aggressive underlying disease and more active
cancer therapy that potentially could manifest in
a more pronounced vulnerability to pain. However,
we were unable to explore this further in the
present study. It is well known that anxiety before
onset of pain predicts elevated pain intensity during acute pain perception.8,9 We found that both
occurrence of anxiety about BMA needle-insertion
and BMA diagnostic outcome predicted the occurrence of procedural pain. Many patients with
malignancy fear a relapse of their disease34 and
might therefore be anxious about the procedure
outcome, as was stated by 63% of our patients.
Regarding the pain intensity and association
with underlying factors, anxiety about the BMA
outcome was not associated with a higher intensity
of pain, whereas anxiety about needle-insertion
was. Anxiety about needle-insertion could be associated with needle phobia, which is a common
phenomenon affecting approximately 10% of a
normal population with varying severity35, and
the prevalence is probably higher in cancer patients.36 A longer duration of BMA was also related
to a higher pain intensity, which is in agreement
with the findings of other researchers.21,22 The
361
Y. Lidén et al.
perceived lack of written information was another
factor associated with more intense procedural
pain. Preoperative information has been found to
reduce patients’ pain experience of postoperative
pain.37 When most diagnostic invasive procedures
are performed electively, there should be good
opportunities to inform the patient for a better
understanding. Adequate information might also
decrease the intensity of procedure-related anxiety.
Even though 70% of our patients reported procedure-related pain, it must be highlighted that
93% were satisfied with the pain treatment. This is
of interest, given that only local anesthesia was
administered. High satisfaction despite pain is a
known paradox, and may include a combination of
expectations, relationship issues, previous experiences of pain relief and care goals.38 The discrepancy could be related to the fact that our patients
believed that the physician had done his or her best
to alleviate the pain,39 that the pain was unavoidable or that patients were satisfied with care given
provided by the nurses. Ward and Gordon40 found
that whether in-patients with severe pain were
satisfied or not depended on average pain, but
not current or worst pain.
Our study has several strengths including its
prospective design, large sample size, high response rate and a broad range of variables assessed. But, there are some limitations as well.
Among patients who reported no pain during
BMA, 60% did not provide a VAS score and 40%
indicated VAS 1–30 mm. These facts limited our
ability to conduct a multivariate analysis of factors
associated with BMA-pain intensity. An inherent
limitation when using anxiety questionnaires is the
risk of triggering patients’ degree of anxiety, which
subsequently may have a negative influence on the
pain experience. However, in our study, we believe
that this impact was small because our data on
frequency of pain are comparable to results from
studies on BMA pain where anxiety was not
explored.21,22 Furthermore, several statistical tests
were conducted, increasing the risk of type I error.
The results of our study demonstrate that the
majority of adult patients experience pain on undergoing BMA. Importantly, one-third of the patients who suffered from pain reported severe pain.
In a few patients, the BMA-related pain lasted for 1
week. Pre-existing pain, anxiety about the diagnostic outcome of BMA and needle-insertion and low
employment status (sick-leave/unemployed) were
factors predicting occurrence of pain. These risk
factors can be used to identify patients in need of
362
complementary interventions to alleviate procedure-related pain.
Acknowledgements
This study was supported by grants from the Swedish Blood
Cancer Society, the Centre for Health Care Science at Karolinska Institutet Stockholm County Council and the Intramural
program of the National Cancer Institute, National Institutes of
Health, US The authors wish to thank Bo Nilsson for valuable
help with the statistical analysis and physicians and nurses
performing the BMAs.
Conflicts of interest: The authors have no relevant relationships
and no conflicts of interest to disclose.
References
1. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D.
Survey of chronic pain in Europe: prevalence, impact on
daily life, and treatment. Eur J Pain: Ejp 2006; 10 (4): 287–
333.
2. Niscola P, Arcuri E, Giovannini M, Scaramucci L, Romani
C, Palombi F, Trapé G, Morabito F. Pain syndromes in
haematological malignancies: an overview. Hematol J 2004;
5 (4): 293–303.
3. van den Beuken-van Everdingen MH, de Rijke JM, Kessels
AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain
in patients with cancer: a systematic review of the past 40
years. Ann Oncol 2007; 18 (9): 1437–49.
4. Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Coyle N, Smart-Curley T, Kemeny N,
Norton L, Hoskins W, Scher H. Symptom prevalence,
characteristics and distress in a cancer population. Qual
Life Res 1994; 3 (3): 183–9.
5. Strang P. Cancer pain – a provoker of emotional, social and
existential distress. Acta Oncol 1998; 37 (7–8): 641–4.
6. Aass N, Fossa SD, Dahl AA, Moe TJ. Prevalence of anxiety
and depression in cancer patients seen at the Norwegian
Radium Hospital. Eur J Cancer 1997; 33 (10): 1597–604.
7. Kalkman CJ, Visser K, Moen J, Bonsel GJ, Grobbee DE,
Moons KG. Preoperative prediction of severe postoperative
pain. Pain 2003; 105 (3): 415–23.
8. Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC.
Preoperative anxiety and postoperative pain in women
undergoing hysterectomy. A repeated-measures design.
J Psychosom Res 2000; 49 (6): 417–22.
9. Ozalp G, Sarioglu R, Tuncel G, Aslan K, Kadiogullari N.
Preoperative emotional states in patients with breast cancer
and postoperative pain. Acta Anaesthesiol Scand 2003; 47 (1):
26–9.
10. Chapman CR, Gavrin J. Suffering: the contributions of
persistent pain. Lancet 1999; 353 (9171): 2233–7.
11. Perkins FM, Kehlet H. Chronic pain as an outcome of
surgery. A review of predictive factors. Anesthesiology 2000;
93 (4): 1123–33.
12. Wincent A, Liden Y, Arner S. Pain questionnaires in the
analysis of long lasting (chronic) pain conditions. Eur
J Pain: Ejp 2003; 7 (4): 311–21.
13. Enskar K, Carlsson M, Golsater M, Hamrin E, Kreuger A.
Life situation and problems as reported by children with
cancer and their parents. J Pediatr Oncol Nurs 1997; 14 (1):
18–26.
14. Ljungman G, Gordh T, Sorensen S, Kreuger A. Pain in
paediatric oncology: interviews with children, adolescents
and their parents. Acta Paediatr 1999; 88 (6): 623–30.
15. Zernikow B, Meyerhoff U, Michel E, Wiesel T, Hasan C,
Janssen G, Kuhn N, Kontny U, Fengler R, Görtitz I, Andler
W. Pain in pediatric oncology – children’s and parents’
perspectives. Eur J Pain: Ejp 2005; 9 (4): 395–406.
16. Brausi MA, Verrini G, De Luca G, Viola M, Simonini GL,
Peracchia G, Gavioli M. The use of local anesthesia with NDO injector (Physion) for transurethral resection (TUR) of
bladder tumors and bladder mapping: preliminary results
and cost-effectiveness analysis.[see comment]. Eur Urol
2007; 52 (5): 1407–11.
17. Brennan PA, Mackenzie N, Oeppen RS, Kulamarva G,
Thomas GJ, Spedding AV. Prospective randomized clinical
trial of the effect of needle size on pain, sample adequacy
and accuracy in head and neck fine-needle aspiration
cytology. Head Neck 2007; 29 (10): 919–22.
18. Daltrey IR, Kissin MW. Randomized clinical trial of the
effect of needle gauge and local anaesthetic on the pain of
breast fine-needle aspiration cytology. Brit J Surg 2000; 87
(6): 777–9.
19. Gursoy A, Ertugrul DT, Sahin M, Tutuncu NB, Demirer
AN, Demirag NG. The analgesic efficacy of lidocaine/
prilocaine (EMLA) cream during fine-needle aspiration
biopsy of thyroid nodules. Clin Endocrinol 2007; 66 (5):
691–4.
20. Kilciler M, Demir E, Bedir S, Erten K, Kilic C, Peker AF.
Pain scores and early complications of transrectal ultrasonography-guided prostate biopsy: effect of patient position. Urol Int 2007; 79 (4): 361–3.
21. Kuball J, Schuz J, Gamm H, Weber M. Bone marrow
punctures and pain. Acute Pain 2004; 6: 9–14.
22. Vanhelleputte P, Nijs K, Delforge M, Evers G, Vanderschueren S. Pain during bone marrow aspiration: prevalence and
prevention. J Pain Symptom Manage 2003; 26 (3): 860–6.
23. Collins SL, Moore RA, McQuay HJ. The visual analogue
pain intensity scale: what is moderate pain in millimetres?
Pain 1997; 72 (1–2): 95–7.
24. Carlsson AM. Assessment of chronic pain. II. Problems in
the selection of relevant questionnaire items for classification of pain and evaluation and prediction of therapeutic
effects. Pain 1984; 19 (2): 173–84.
25. Spielberger CD, Vagg PR. Psychometric properties of the
STAI: a reply to Ramanaiah, Franzen, and Schill. J Pers
Assess 1984; 48 (1): 95–7.
26. Forsberg C, Bjorvell H. Swedish population norms for the
GHRI, HI and STAI-state. Qual Life Res 1993; 2 (5): 349–56.
27. Wettergren L, Bjorkholm M, Axdorph U, Bowling A,
Langius-Eklof A. Individual quality of life in long-term
survivors of Hodgkin’s lymphoma – a comparative study.
Qual Life Res 2003; 12 (5): 545–54.
28. Cohen J. Statistical power analysis for the behavioral sciences,
2nd edn. Hillsdale, NJ: Lawrence Erlbaum Associates, 1988.
29. Steedman B, Watson J, Ali S, Shields ML, Patmore RD,
Allsup DJ. Inhaled nitrous oxide (Entonox) as a short acting
sedative during bone marrow examination. Clin Lab Haematol 2006; 28 (5): 321–4.
30. Woolf CJ. Evidence for a central component of post-injury
pain hypersensitivity. Nature 1983; 306 (5944): 686–8.
31. Kalso E. Memory for pain. Acta Anaesthesiol Scand Suppl
1997; 110: 129–30.
32. Olorunto WA, Galandiuk S. Managing the spectrum of
surgical pain: acute management of the chronic pain
patient. J Am Coll Surg 2006; 202 (1): 169–75.
33. Rapp SE, Ready LB, Nessly ML. Acute pain management in
patients with prior opioid consumption: a case–controlled
retrospective review. Pain 1995; 61 (2): 195–201.
34. Lee-Jones C, Humphris G, Dixon R, Hatcher MB. Fear of
cancer recurrence – a literature review and proposed
cognitive formulation to explain exacerbation of recurrence
fears. Psycho-Oncol 1997; 6 (2): 95–105.
35. Hamilton JG. Needle phobia: a neglected diagnosis. [see
comment]. J Fam Pract 1995; 41 (2): 169–75.
36. Kettwich SC, Sibbitt WL Jr., Brandt JR, Johnson CR, Wong
CS, Bankhurst AD. Needle phobia and stress-reducing
medical devices in pediatric and adult chemotherapy
patients. J Pediatr Oncol Nurs 2007; 24 (1): 20–8.
37. Timmons ME, Bower FL. The effect of structured preoperative teaching on patients’ use of patient-controlled analgesia (PCA) and their management of pain. Orthop Nurs 1993;
12 (1): 23–31.
38. Dawson R, Spross JA, Jablonski ES, Hoyer DR, Sellers DE,
Solomon MZ. Probing the paradox of patients’ satisfaction
with inadequate pain management.[see comment]. J Pain
Symptom Manage 2002; 23 (3): 211–20.
39. Mueller PR, Biswal S, Halpern EF, Kaufman JA, Lee MJ.
Interventional radiologic procedures: patient anxiety,
perception of pain, understanding of procedure, and satisfaction with medication – a prospective study. Radiology
2000; 215 (3): 684–8.
40. Ward SE, Gordon DB. Patient satisfaction and pain severity
as outcomes in pain management: a longitudinal view of
one setting’s experience. J Pain Symptom Manage 1996; 11
(4): 242–51.
Address:
Ylva Lidén
Department of Anesthesia
Surgical Services and Intensive Care
Multidisciplinary Pain Center
Karolinska University Hospital Solna
SE-171 76 Stockholm
Sweden
e-mail: [email protected]
363
European Journal of Oncology Nursing 16 (2012) 323e329
Contents lists available at ScienceDirect
European Journal of Oncology Nursing
journal homepage: www.elsevier.com/locate/ejon
Pain and anxiety during bone marrow aspiration/biopsy: Comparison of ratings
among patients versus health-care professionals
Y. Lidén a, *, N. Olofsson a, O. Landgren b, c, E. Johansson b, d
a
Department of Physiology and Pharmacology, Section for Anesthesiology and Intensive Care, Karolinska Institutet, Stockholm, Sweden
Department of Medicine, Division of Hematology, Karolinska Institutet, Stockholm, Sweden
Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institute of Health, Bethesda, MD, USA
d
Red Cross University College, Stockholm, Sweden
b
c
a b s t r a c t
Keywords:
Pain
Anxiety
Agreement
Health-care professionals
Patient
Purpose: To assess pain and anxiety during bone marrow aspiration/biopsy (BMA) among patients versus
health-care professionals (HCPs).
Method: 235 adult hematologic patients undergoing BMA were included. BMA was performed by 16
physicians aided by nine registered nurses (RNs). Questionnaires were used to obtain patients and HCPs
ratings of patients’ pain and anxiety during BMA. Patterns of ratings for pain and anxiety among patients
HCPs were estimated with proportions of agreement P(A), Cohen’s kappa coefficient (k), and singlemeasure intra-class correlation (ICC). We also explored if associations of ratings were influenced by
age, sex, type and duration of BMA.
Results: The P(A) for occurrence of rated pain during BMA was 73% between patients and RNs, and 70%
between patients and physicians, the corresponding k was graded as fair (0.37 and 0.33). Agreement
between patients and HCPs regarding intensity of pain was moderate (ICC ¼ 0.44 and 0.42). Severe pain
(VAS > 54) was identified by RNs and physicians in 34% and 35% of cases, respectively. Anxiety about
BMA outcome and needle insertion was underestimated by HCPs. P(A) between patients and RNs and
patients and physicians regarding anxiety ranged from 53% to 59%. The corresponding k was slight to fair
(0.10e0.21). ICC showed poor agreement between patients and HCPs regarding intensity of anxiety (0.13
e0.36).
Conclusions: We found a better congruence between patients and HCPs in pain ratings than in anxiety
ratings, where the agreement was low. RNs and physicians underestimated severe pain as well as anxiety
about BMA outcome and needle insertion.
Ó 2011 Elsevier Ltd. All rights reserved.
Introduction
Patients with cancer undergo several different and repeated
diagnostic procedures during the disease trajectory. Pain caused by
various procedures and situations is defined as procedural pain, i.e.
an acute increase or sudden onset of pain with short duration
(Heafield,1999). Among the most painful procedures are those when
instruments or devices are inserted into the body, usually by cutting
or puncturing the skin (Coutaux et al., 2008). In a recent study, pain
was evaluated in cancer patients undergoing different types of
invasive examination. The highest pain levels were related to the
* Corresponding author. Department of Anesthesia, Surgical Services and Intensive Care, Multidisciplinary Pain Center, Karolinska University Hospital Solna, SE171 76 Stockholm, Sweden. Tel.: þ46 8 51774607; fax: þ46 8 51773132.
E-mail address: [email protected] (Y. Lidén).
1462-3889/$ e see front matter Ó 2011 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ejon.2011.07.009
procedures bone marrow aspiration/biopsy (BMA), lumbar puncture
and insertion of central venous catheter (Portnow et al., 2003).
BMA is commonly performed in hematological patients to
confirm diagnosis and to evaluate response to therapy. In adult
patients, local infiltration anesthesia is routinely applied before
BMA (Kuball et al., 2004). Previously, we conducted a prospective
longitudinal study on procedure-related pain among adult hematologic patients who underwent BMA (Liden et al., 2009). Similar to
prior studies (Dunlop et al., 1999; Vanhelleputte et al., 2003; Kuball
et al., 2004; Steedman et al., 2006), we found BMA-related pain to
be common: 70% of the patients reported pain during BMA and 35%
reported severe-to-worst-possible pain (Liden et al., 2009).
Reasons for not preventing pain related to BMA may depend on
health-care professionals’ insufficient knowledge of procedural
pain, or on inadequate pain analysis (Field, 1996; Drayer et al., 1999;
Sjostrom et al., 1999; Puntillo et al., 2003). Another possible barrier
324
Y. Lidén et al. / European Journal of Oncology Nursing 16 (2012) 323e329
to efficient pain treatment may be poor congruence of the ratings
for pain among patients versus health-care professionals (Drayer
et al., 1999). Health-care professionals’ estimates of cancer
patients’ pain commonly diverge from the patients’ own experience (Grossman et al., 1991; Sneeuw et al., 1999; Kuball et al., 2004;
Budischewski et al., 2006). Health-care professionals seem to
overestimate mild pain and underestimate severe pain (Grossman
et al., 1991; Kuball et al., 2004; Budischewski et al., 2006).
Anxiety often co-exists with and exacerbates the perception of pain
(Ozalp et al., 2003). A poor correlation between cancer patients’ and
health-care professionals’ assessments of anxiety is also reported
(Badner et al., 1990; Heikkila et al., 1998; Martensson et al., 2008).
Although poor agreement between patients’ and health-care
professionals’ ratings of cancer patients’ pain and anxiety is
recognized, to our knowledge, there is limited empirical research
focusing on procedures. Procedures are often associated with
considerable discomfort and pain (Portnow et al., 2003) why such
knowledge would be of value for adequate symptom management.
The aim of the present study was to assess ratings for pain and
anxiety during BMA among patients versus health-care professionals. Also we explored whether patterns of ratings were influenced by the patients’ age or sex, as well as the type and duration of
BMA.
Methods and material
Subjects
Two hundred thirty-five (median age 62 years, range 20e89
years) of 263 (89.4%) consecutive adult patients scheduled for BMA
at the outpatient clinic of the Division of Hematology, Karolinska
University Hospital, were included (Table 1). Patients could only be
enrolled once. Inclusion criteria were age 18 years or older and with
a scheduled BMA. Exclusion criteria were mental disorders and
linguistic difficulties, unwillingness to participate, not showing up
on time for the BMA, sedative medication, or fainting before BMA.
Informed consent was obtained from all patients prior to study
Table 1
Patients’ characteristics.
Variable
Total number, n (%)
Age, median years (range)
235
62
(100)
(20e89)
Sex, n (%)
Female
Male
109
126
(46)
(54)
34
39
46
18
31
42
25
(14)
(17)
(19)
(8)
(13)
(18)
(11)
Previous BMA, n (%)
No previous BMA
1e2 times
3e5 times
>5 times
100
76
27
32
(43)
(32)
(11)
(14)
Site of BMA, n (%)
Posterior iliac crest
Sternum
230
5
(98)
(2)
67
88
80
(28)
(37)
(35)
Underlying diagnosis according to BMA, n (%)
Leukemia
Multiple myeloma
Lymphoma
Type of BMA, n (%)
Bone marrow biopsy
enrollment. The study was approved by the Regional Ethics
Committee in Stockholm.
The BMAs were performed by nine attending hematologists and
seven hematology fellows (female n ¼ 10, male n ¼ 6). Twenty-six
percent of the BMAs were performed by attending hematologists
and 74% by hematology fellows. Seven out of nine attending
hematologists and six out of seven hematology fellows had performed more than 100 BMAs previously. Nine RNs assisted the
physicians during the BMAs. All the RNs were female with a median
of four years (range 1e19 years) of professional experience.
Bone marrow aspiration/biopsy
As pain relief, a local anesthetic (Lidocaine 1% 10e20 ml) was
given subcutaneously as well as with periostal infiltration. After
local anesthesia, BMA was carried out using a 15 gauge 2.7 inch
aspiration needle and/or 11 gauge 4 inch biopsy needle (Medical
Device Technologies, Inc).
Data collection
Self-administered questionnaires were used to obtain information about pain and anxiety from the patients (Liden et al., 2009)
and to assess physicians’ and RNs impressions of patients’ experience of pain and anxiety.
Questionnaires to patients
Prior to the BMA, the patients answered a study-specific questionnaire including questions concerning anxiety about BMA needle insertion and BMA outcome. First, the presence or absence of
anxiety was recorded. Thereafter the intensity of anxiety was
scored on Visual Analog Scales (VAS) ranging from 0 to 100 mm
anchored 0 mm ¼ no anxiety and 100 mm ¼ worst possible anxiety.
The participants were requested to mark the point on each line that
best agreed with their experience of anxiety.
Ten minutes after the BMA, a second study-specific questionnaire about pain during the procedure was completed by the
patients. First, presence or absences of pain was recorded. Then, the
intensity of pain was scored on VAS with 0 mm ¼ no pain and
100 mm ¼ worst possible pain. Intensity > 30 mm on VAS was
considered to represent moderate pain and VAS > 54 mm severe
pain (Collins et al., 1997).
Questionnaires to physicians and registered nurses
The physicians performing the BMAs and the assisting RNs
individually filled out a questionnaire immediately after completion of each BMA. They recorded their assessments of the patient’s
pain during the BMA, anxiety about the needle insertion and
anxiety about the outcome (presence or absence and intensity on
VAS), without knowing the patients’ responses in the patient
questionnaires. Using a standardized data-entry form, physicians
and RNs also recorded their own gender, and the number of years
working in hematology. Physicians also recorded the estimated
number of BMAs they had carried out, as well as clinical information regarding the patient.
Statistics
Associations of ratings for occurrence of pain and anxiety during
BMA among patients versus health-care professionals were assessed
using proportions of agreement P(A) and Cohen’s unweighted kappa
coefficient (k), correcting for the eventuality that agreement could
occur by chance alone. In accord with Landis and Koch (1977), the
magnitude of the k values was graded as follows: k 0 ¼ poor; k
0.01e0.20 ¼ slight;
0.21e0.40 ¼ fair;
0.41e0.60 ¼ moderate;
0.61e0.80 ¼ substantial; and 0.81e1.0 ¼ almost perfect agreement.
Using the McNemar test we tested for marginal homogeneity
between ratings of occurrence of pain and anxiety among patients
versus health-care professionals (McNemar, 1947; Maxwell, 1970). A
significant value implies that the health-care professionals either
under- or overestimated the patients rating. Agreement between the
patients’ and the health-care professionals’ scoring of intensity of
pain and anxiety by using VAS was evaluated with single-measure
intra-class correlation (ICC) (Shrout and Fleiss, 1979). Based on the
literature, ICC values were graded as follows: <0.4 ¼ poor agreement; 0.4e0.74 ¼ moderate agreement; 0.75e1 ¼ good agreement
(Shrout and Fleiss, 1979; Fleiss, 1986). We further explored associations of ratings for pain and anxiety during BMA among patients
versus health-care professionals, by age of the patient (below/above
60 years), sex (female/male), type of BMA (bone marrow aspiration,
bone marrow biopsy, or both), and duration of BMA (below/above
15 min). The level of all statistical tests was set at 0.05. The statistical
calculations were done with the Stat View 5.0.1 and SPSS 14.0
software.
325
the P(A) was 70%. The corresponding k-values were 0.37 and 0.33,
respectively; these were both graded as fair (Table 2). For cases
where the BMA took more than 15 min, the k-value for the rated
occurrence was graded as moderate (Table 2).
Agreement on rated intensity of pain was graded moderate
between patients and RNs (ICC ¼ 0.44) and patients and physicians
(ICC ¼ 0.42), respectively (Table 2). Agreement regarding rated
intensity of pain was moderate among RNs and physicians for
patients with an age of 60 years or younger, for male patients, when
bone marrow biopsy was performed alone or together with aspiration, and when BMA took >15 min (0.42e0.60) (Table 2).
Severe pain (VAS > 54) reported by patients was identified by
RNs and physicians in 34% and 35% of cases, respectively (Figs. 1 and
2). Two patients scored worst possible pain, without being
observed by an RN in one case or a physician in the other. Moderate
pain (VAS >30 to 54) reported by patients was identified to 18%
by RNs and 26% by physicians (Figs. 1 and 2). Mild pain (VAS 30)
reported by patients was identified to 78% by RNs and 58% by
physicians. Six RNs and ten physicians scored an intensity of pain
(median VAS 16 (range 3e56), VAS 20 (range 3e69), respectively)
in patients who did not report occurrence of pain.
Results
Agreement of occurrence and intensity of pain, between patients
and health-care professionals
Agreement between patients and health-care professionals on
occurrence and intensity of anxiety for BMA outcome
The P(A) for rated occurrence of pain during BMA among
patients versus RNs was 73%; and among patients versus physicians
The P(A)s for occurrence of anxiety for BMA outcome between
patients and RNs and patients and physicians were 56% and 55%,
Table 2
Level of agreement for ratings of occurrence and intensity of pain between patients, registered nurses and physicians (n ¼ 235).
Variable
n
P(A)a
Kappab
McNemarc
VAS, n
Patient VAS, median (range)
Nurse/physician, median (range)
ICCd
95% CI
Pain during BMA
Nurse, total
234
73%
0.37
0.614
185
30 (1e100)
20 (1e100)
0.44
(0.27e0.58)
Patients age
60 years
>60 years
108
126
78%
69%
0.34
0.35
0.540
0.200
90
95
30 (2e100)
27 (1e100)
25 (3e100)
20 (3e100)
0.58
0.28
(0.41e0.71)
(0.07e0.46)
Sex
Female
Male
109
125
70%
76%
0.10
0.46
0.296
0.855
88
97
36 (1e100)
27 (2e100)
22 (2e100)
19 (1e95)
0.39
0.50
(0.17e0.57)
(0.31e0.65)
88
66
80
73%
64%
81%
0.39
0.16
0.51
0.838
0.540
0.606
67
52
66
20 (3e100)
38 (3e100)
31 (1e100)
18 (2e95)
20 (1e90)
25 (3e100)
0.46
0.26
0.58
(0.25e0.63)
(.002 to 0.49)
(0.36e0.73)
BMA duration
15 min
>15 min
181
50
69%
86%
0.31
0.55
0.350
0.453
41
142
25 (2e100)
45 (1e99)
18 (1e90)
36 (6e1009
0.40
0.45
(0.20e0.56)
(0.18e0.66)
Pain during BMA
Physician, total
234
70%
0.33
0.073
156
36 (2e100)
21 (2e100)
0.42
(0.23e0.56)
Age
60 years
>60 years
107
127
70%
70%
0.25
0.37
0.216
0.256
78
78
37 (2e1009
36 (3e100)
27 (2e100)
16 (2e92)
0.60
0.19
(0.41e0.73)
(0.19e0.38)
Sex
Female
Male
109
125
72%
69%
0.35
0.32
0.012
0.873
74
82
40 (4e100)
28 (2e100)
22 (2e100)
20 (2e90)
0.35
0.50
(0.09e0.55)
(0.31e0.65)
87
67
80
68%
72%
71%
0.31
0.37
0.32
0.850
0.359
0.095
55
45
56
25 (3e100)
43 (3e100)
37 (2e100)
20 (2e85)
15 (2e90)
26 (2e100)
0.52
0.16
0.50
(0.29e0.69)
(.09 to 0.40)
(0.24e0.69)
182
50
68%
78%
0.30
0.42
0.118
0.274
120
35
27 (3e100)
56 (2e99)
18 (2e90)
34 (4e100)
0.37
0.42
(0.17e0.53)
(0.19e0.65)
Type of BMA
Biopsy
Aspiration
Biopsy and aspiration
Type of BMA
Bone marrow biopsy
Biopsy and aspiration
BMA duration
15 min
>15 min
a
b
c
d
Proportions of agreement P(A).
Kappa, corrects for the eventuality that agreement could occur by chance alone.
Test marginal homogeneity between ratings of occurrence of pain among patients versus health-care professionals.
Agreement between the patients’ and the health-care professionals’ scoring of intensity of pain by using VAS was evaluated with single-measure intra-class correlation (ICC).
326
regarding age, sex, type of BMA and BMA duration the ICC was in
the poor range (.01 to 0.38) (Table 3).
Agreement between patients and health-care professionals on
occurrence and intensity of anxiety about needle insertion
Fig. 1. Intensity of pain during BMA. Data of 185 patients/185 RNs ratings who both
reported that patient experienced pain during BMA. Intra-Class Correlation (ICC) 0.44
and 95% confidence interval (CI) 0.27e0.58.
respectively. The corresponding k was graded as slight (0.19 and
0.14). k appeared fair between patients and RNs when both biopsy
and aspiration was performed and when BMA took more than
15 min (0.29 and 0.33) and between patient and physicians when
bone marrow aspiration was performed (0.28). k was slight for the
remaining variables (0.02e0.17) (Table 3). RNs and physicians
significantly (p < 0.01) underestimated anxiety about BMA
outcome (Table 3).
The ICC showed poor agreement of rated intensity of anxiety for
BMA outcome between patients and health-care professionals. ICC
demonstrated moderate agreement among physicians and patients
with an age of 60 years or younger (0.46). In all other analyzes
Patients’ reported pain intensity during
BMA scored on VAS 0-100 mm
100
90
80
70
60
50
40
30
20
10
0
0
10
20
30
40
50
60
70
80
90
100
Physicians’ reported patients’ pain intensity during BMA,
scored on VAS 0-100 mm
Fig. 2. Intensity of pain during BMA. Data of 156 patients/156 physicians’ ratings who
both reported that patient experienced pain during BMA. Intra-Class Correlation (ICC)
0.42 and 95% confidence interval (CI) 0.23e0.56.
The P(A)s between patients and RNs and patients and physicians
for rated occurrence of anxiety about needle insertion were 53%
and 59% respectively. The corresponding k was graded as slight and
fair. Between patients and RNs, k appeared fair when both biopsy
and aspiration were performed (0.23). Between patients and
physicians, the following variables were fair; patients’ age > 60
years, when bone marrow aspiration was performed, when bone
marrow biopsy was performed, and when the BMA took more than
15 min (0.22e0.23). k was slight for the remaining variables
(Table 4). Health-care professionals significantly (p < 0.001)
underestimated patients’ anxiety regarding needle insertion
(Table 4).
ICC demonstrated poor agreement between patients and
health-care professionals regarding intensity of anxiety about
needle insertion. ICC demonstrated moderate agreement between
physicians and patients with an age >60 years, when both biopsy
and aspiration were performed and when BMA took >15 min
(0.41e0.50). In all other analyses regarding age, sex, type of BMA
and BMA duration the ICC was in the poor range (0.10e0.40).
Discussion
Overall we found a discrepancy in ratings of occurrence of pain
between patients and health-care professionals. Furthermore, our
results showed low agreement on rated anxiety about the BMA
outcome and needle insertion; and that both RNs and physicians
underestimated patients’ pain and anxiety. These finding are novel
and of major importance because incongruence in ratings and in
particular underestimation of patients’ experience of pain and
anxiety during BMA may lead to unnecessary suffering for patients.
In our study, the level of agreement for rated pain by patients
and health-care professionals during BMA was graded as fair. In
a prior study by Kuball et al. (2004) the level of agreement between
patients and physicians was graded as moderate. We were unable
to further assess underlying causes of these discrepancies and we
have speculated that they may be due to differences in patient
populations and/or health-care professionals. The rating for
intensity of pain during BMA among patients versus health-care
professionals was graded moderate. Importantly, in accord with the
literature (Grossman et al., 1991; Harrison, 1991; Curtiss, 2001;
Kuball et al., 2004), the occurrence of severe pain (>54 mm on
VAS), present in 32% of the patients, was recognized by the RNs and
physicians only in one third of the affected patients. Indeed,
underestimation of severe pain, including procedural pain, appears
to be common in a variety of patient care settings (Grossman et al.,
1991; Harrison, 1991; Curtiss, 2001; Kuball et al., 2004). Prior
studies have suggested that underestimation of severe pain could
depend on RNs’ and physicians’ working experience, where those
with longer experience have been found to underestimate the pain
more frequently than do those with less experience (Choiniere
et al., 1990; Marquie et al., 2003). As pointed out previously,
a difference with regard to ratings of pain among patients and
health-care professionals might depend on that the two groups
relate to different experience when scoring pain (Gollop, 1986;
Levin et al., 1998). For example, while the patient refers to his/her
personal prior pain experience, a health-care professional relates
both to his/her personal prior pain experience as well as the range
of pain among prior patients (Gollop, 1986; Levin et al., 1998). We
found better agreement for the rated occurrence of pain between
327
Table 3
Agreement on occurrence and intensity of anxiety about BMA outcome between patients and registered nurses and physicians (n ¼ 235).
Variable
n
P(A)a
Kappab
McNemarc
VAS, n
ICCd
95% CI
Anxiety about BMA outcome
Nurse, total
227
56%
0.19
0.009
147
50 (1e100)
18 (1e100)
0.13
(0.03 to 0.28)
Age
60 years
>60 years
104
123
63%
54%
0.09
0.08
0.045
0.111
80
67
54 (1e100)
37 (2e100)
22 (2e100)
15 (1e85)
0.22
.01
(.01 to 0.42)
(.16 to 0.16)
Sex
Female
Male
108
119
58%
55%
0.13
0.10
0.007
0.341
76
71
60 (2e1009
34 (1e100)
18 (2e100)
20 (1e74)
0.08
0.09
(.08 to 0.26)
(.09 to 0.26)
87
64
76
52%
53%
64%
0.02
0.07
0.29
0.165
0.018
0.700
57
46
44
48 (1e100)
50 (3e100)
51 (2e100)
18 (2e1009
20 (1.87)
18 (2e83)
0.11
0.07
0.22
(.10 to 0.33)
(.11 to 0.28)
(.06 to 0.48)
BMA duration
15 min
>15 min
176
48
53%
67%
0.06
0.33
0.020
0.453
113
32
50 (1e100)
46 (2e100)
18 (1e95)
22 (2e100)
0.12
0.14
(.04 to 0.29)
(.16 to 0.44)
Anxiety about BMA outcome
Physician, total
234
55%
0.14
0.000
98
50 (1e100)
23 (2e100)
0.30
(0.06e0.50)
Age
60 years
>60 years
107
127
51%
57%
0.05
0.16
0.001
0.0002
59
39
50 (1e100)
50 (2e100)
26 (2e100)
20 (3e85)
0.46
0.07
(0.17e0.66)
(.14 to 0.31)
Sex
Female
Male
109
125
54%
55%
0.11
0.12
0.000
0.002
51
47
63 (1e100)
34 (1e100)
27 (4e100)
18 (2e799
0.18
0.36
(.05 to 0.42)
(0.06e0.60)
87
67
80
51%
61%
54%
0.05
0.28
0.10
0.006
0.000
0.049
37
31
30
49 (1e100)
60 (4e100)
51 (2e100)
21 (2e100)
26 (4e79)
22 (3e100)
0.27
0.38
0.28
(.02 to 0.54)
(.06 to 0.68)
(.04 to 0.56)
182
50
52%
60%
0.12
0.17
0.000
0.500
73
25
52 (1e100)
45 (2e100)
21 (2e100)
35 (5e100)
0.32
0.24
(0.01e0.56)
(.15 to 0.57)
Type of BMA
Bone marrow biopsy
Both biopsy and aspiration
Type of BMA
Bone marrow biopsy
BMA duration
15 min
>15 min
a
Kappa corrects for the eventuality that agreement could occur by chance alone.
Test marginal homogeneity between ratings of occurrence of anxiety among patients versus health-care professionals.
d
Agreement between the patients’ and the health-care professionals’ scoring of intensity of anxiety by using VAS was evaluated with single-measure intra-class correlation
(ICC).
b
c
patients and health-care professionals when, e.g., the BMA took
more than 15 min, suggesting that staff might expect a longer BMA
to be more painful since such BMAs may often be associated with
procedure-related problems. Another proposed factor that influences the evaluation of rated pain among patients and health-care
professionals is that health-care professionals sometimes believe
some patients to exaggerate the severity of their pain (Drayer et al.,
1999) while they sometimes believe that other patients act as they
have to endure some pain (Idvall, 2002) and therefore ignore its
intensity.
The diagnosis of cancer causes the patient anxiety and stress,
which are due to the patients’ perception of cancer, its manifestations, and treatment (Ozalp et al., 2003; Degen et al., 2010). Indications for BMA include the diagnosis, staging and therapeutic
monitoring of the disease. Most patients with hematological
malignancies must undergo repeated BMAs (Bain, 2001; Degen
et al., 2010). Anxiety about the diagnostic outcome of the BMA
increases the patients’ experience of pain during BMA (Liden et al.,
2009). To our knowledge, our study is the first systematic investigation of rated anxiety by BMA outcome conducted by patients,
RNs and physicians. We found that patients expressed anxiety
about the BMA outcome more frequently and much more intensely
than the RNs and physicians were able to identify. Previous studies
on anxiety and depression in hospitalized patients with cancer
have also reported poor-to-slight agreement between cancer
patients’ and staff’s ratings of anxiety (Lampic et al., 1996). Some
studies observe that staff tends to overestimate anxiety and
emotional distress (Faller et al., 1995; Lampic et al., 1996; Heikkila
et al., 1998; Lampic and Sjoden, 2000; Martensson et al., 2008)
whilst others have found that this is not the case (Badner et al.,
1990; von Essen, 2004). It has been suggested that poor skill in
identifying patients’ anxiety may be because staff lack the time to
discern the patients’ emotional distress; but also that patients do
not express their anxiety (Radwin, 1996; Kruijver et al., 2006).
Regarding anxiety over needle insertion, we found poor-toslight agreement between patient and health-care professionals.
Both RNs and physicians strongly underestimated patients’ anxiety
here. In the literature, needle anxiety is well known among patients
with diabetes, those undergoing dental procedures and those on
intravenous chemotherapy (Hamilton, 1995; Mollema et al., 2001;
Kettwich et al., 2007). Needle anxiety can be traced back to an
adverse experience with needles in health-care. A bad experience
can lead to a generalized, learned, negative response to different
needle procedure (Marks, 1988). Most patients with blood cancer
undergo intensive chemotherapy, venepunctures, lumbar punctures and repeated BMAs. Their attitude should be assessed, as the
development of needle anxiety may cause delay or avoidance of
appropriate medical care.
The main methodological strengths of the present study are the
large sample size and the high response rate. Further, the physicians and RNs were blinded to the patients’ ratings of pain and
anxiety. However, one limitation is that we compared small staff
samples with a larger patient sample. Differences between individual RNs and physicians such as personal characteristics may thus
328
Table 4
Agreement on occurrence and intensity of anxiety about needle insertion between patient and registered nurse and physicians (n ¼ 235).
Variable
n
P(A)a
Kappab
McNemarc
VAS, n
ICCd
95% CI
Anxiety about needle insertion
Nurse, total
233
53%
0.10
0.0000
132
48 (1e100)
10 (1e100)
0.24
(.05 to 0.47)
Age
60 years
>60 years
107
126
51%
55%
0.10
0.05
0.0000
0.0002
71
61
50 (1e100)
44 (2e1009
13 (1e100)
10 (1e83)
0.31
0.15
(.06 to 0.59)
(.07 to 0.36)
Sex
Female
Male
109
124
50%
56%
0.07
0.09
0.0001
0.0006
67
65
64 (1e100)
44 (1e98)
14 (1e100)
9 (1e83)
0.26
0.11
(.06 to 0.53)
(.07 to 0.31)
87
66
80
52%
44%
62%
0.06
0.05
0.23
0.0004
0.0000
0.361
47
45
40
44 (1e100)
50 (4e100)
46 (1e1009
10 (1e78)
9 (1e78)
14 (1e100)
0.23
0.20
0.30
(.07 to 0.50)
(.09 to 0.48)
(.02 to 0.57)
BMA duration
15 min
>15 min
180
50
52%
58%
0.06
0.20
0.000
0.029
97
33
47 (1e100)
64 (1e100)
9 (1e83)
16 (1e100)
0.19
0.29
(.06 to 0.43)
(.05 to 0.58)
Anxiety about needle insertion
Physician total
234
59%
0.21
0.0000
81
50 (81e100)
17 (1e100)
0.36
(0.00e0.60)
Age
60 year
>60 year
107
127
54%
63%
0.18
0.23
0.0000
0.0013
43
38
61 (3e100)
45 (1e100)
17 (2e100)
17 (1e100)
0.31
0.41
(.07 to 0.60)
(0.06e0.66)
Sex
Female
Male
109
125
56%
62%
0.18
0.19
0.0000
0.0000
45
36
74 (3e100)
40 (1e98)
17 (1e100)
17 (2e100)
0.30
0.38
(.05 to 0.58)
(0.01e0.65)
87
67
80
61%
57%
59%
0.24
0.22
0.14
0.004
0.0000
0.082
25
34
22
64 (7e100)
46 (1e100)
75 (3e100)
23 (1e74)
16 (3e71)
15 (2e100)
0.10
0.40
0.50
(.16 to 0.41)
(.08 to 0.71)
(0.06e0.77)
182
50
58%
60%
0.19
0.23
0.0000
0.0442
57
24
47 (1e100)
70 (4e100)
13 (1e100)
34 (3e100)
0.31
0.41
(.06 to 0.59)
(0.03e0.69)
Type of BMA
Bone marrow biopsy
Type of BMA
Bone marrow biopsy
BMA duration
15 min
>15 min
a
Kappa corrects for the eventuality that agreement could occur by chance alone.
Test marginal homogeneity between ratings of occurrence of anxiety among patients versus health-care professionals.
d
Agreement between the patients’ and the health-care professionals’ scoring of intensity of anxiety by using VAS was evaluated with single-measure intra-class correlation
(ICC).
b
c
have influenced the results. On the other hand, the intention was to
investigate the overall agreement between patients, RNs and
physicians, not how individual RNs and physicians assess patients’
pain and anxiety during BMA. Further, the timing when our questionnaires regarding anxiety were completed diverged between
patients, RNs and physicians. Thus, all the patients answered the
anxiety questions prior to the BMA while the staff responded to
these items immediately after each. This could have influenced the
congruence regarding anxiety. However, only this method of
distributing the questionnaires was considered feasible, since the
staff member’s first meeting with the patient was in the consulting
room where the BMA was performed.
The discrepancy between the patients’ perception of pain and
the health-care professionals’ assessment can be a predictor of poor
pain management (Curtiss, 2001). Pre-existing pain and anxiety
about the diagnostic outcome of BMA or needle insertion have been
found to be independent risk factors for increased pain experience
during BMA (Liden et al., 2009). It is therefore of major interest to
take account of the patient’s self-assessment of pain and anxiety.
Today, we know that procedure-related pain may have other
consequences than patients’ acute pain (Wincent et al., 2003).
There is growing evidence that unrelieved acute pain can generate
chronic pain (Kehlet et al., 2006), and pain perception can be
intensified if accompanied by anxiety (Kain et al., 2000; Ozalp et al.,
2003). Thus, it is urgent to develop staff knowledge regarding pain
and anxiety assessment, conduct analyzes and document patients’
pain and anxiety related to BMAs.
In conclusion, we found a discrepancy between patients and
health-care professionals ratings of occurrence and intensity of
pain during BMA. In ratings of anxiety the agreement was even
lower. A slightly better congruence between patients and healthcare professionals was observed when the BMA included a biopsy
or when the BMA took more than 15 min. Our results also show
that both RNs and physicians underestimated severe pain reported
by the patients. Moreover, the health-care professionals underestimated the anxiety for needle insertion and BMA outcome
patients experienced. Results from this study emphasize the need
for adequate symptom assessment. As pain and anxiety are
subjective, patients’ own reports are the most valid measures of the
experience. They can easily be obtained by asking patients to
quantify their pain and anxiety before and after undergoing
a procedure.
Conflict of interest
None of the authors have any financial or personal relationship
with other persons or organizations that could inappropriately
influence the work reported here.
References
Badner, N.H., Nielson, W.R., Munk, S., Kwiatkowska, C., Gelb, A.W., 1990. Preoperative anxiety: detection and contributing factors. Canadian Journal of Anesthesia 37 (4 Pt 1), 444e447.
Bain, B.J., 2001. Bone marrow aspiration. Journal of Clinical Pathology 54 (9),
657e663.
Budischewski, K.M., de la Fuente, F., Nierhoff, C.F., Mose, S., 2006. The burden of pain
of inpatients undergoing radiotherapy e discrepancies in the ratings of physicians and nurses. Onkologie 29 (10), 431e435.
Choiniere, M., Melzack, R., McQuay, H.J., 1990. Comparisons between patients’ and
nurses’ assessment of pain and medication efficacy in severe burn injuries. Pain
40 (2), 143e152.
Collins, S.L., Moore, R.A., McQuay, H.J., 1997. The visual analogue pain intensity
scale: what is moderate pain in millimetres? Pain 72 (1e2), 95e97.
Coutaux, A., Salomon, L., Rosenheim, M., Baccard, A.S., Quiertant, C., Papy, E.,
Blanchon, T., Collins, E., Cesselin, F., Binhas, M., Bourgeois, P., 2008. Care related
pain in hospitalized patients: a cross-sectional study. European Journal of Pain
12 (1), 3e8.
Curtiss, C.P., 2001. JCAHO: meeting the standards for pain management. Orthopedic
Nursing 20 (2), 27e30. 41.
Degen, C., Christen, S., Rovo, A., Gratwohl, A., 2010. Bone marrow examination:
a prospective survey on factors associated with pain. Annals of Hematology 89
(6), 619e624.
Drayer, R.A., Henderson, J., Reidenberg, M., 1999. Barriers to better pain control in
hospitalized patients. Journal of Pain and Symptom Management 17 (6),
434e440.
Dunlop, T.J., Deen, C., Lind, S., Voyle, R.J., Prichard, J.G., 1999. Use of combined oral
narcotic and benzodiazepine for control of pain associated with bone marrow
examination. Southern Medical Journal 92 (5), 477e480.
Faller, H., Lang, H., Schillings, S., 1995. Emotional distress and hope in lung cancer
patients, as perceived by patients, relatives, physicians, nurses and interviewers. Psycho-Oncology 4, 21e31.
Field, L., 1996. Are nurses still underestimating patients’ pain postoperatively?
British Journal of Nursing 5 (13), 778e784.
Fleiss, J., 1986. The design and analysis of clinical experiments. Wiley Inc, New York.
Gollop, S., 1986. Pain: a summary. Nursing (London) 3 (10), 382e383.
Grossman, S.A., Sheidler, V.R., Swedeen, K., Mucenski, J., Piantadosi, S., 1991.
Correlation of patient and caregiver ratings of cancer pain. Journal of Pain and
Symptom Management 6 (2), 53e57.
Hamilton, J.G., 1995. Needle phobia: a neglected diagnosis. Journal of Family Practice 41 (2), 169e175.
Harrison, A., 1991. Assessing patients’ pain: identifying reasons for error. Journal of
Advanced Nursing 16 (9), 1018e1025.
Heafield, R.H., 1999. The management of procedural pain. The Professional Nurse 15
(2), 127e129.
Heikkila, J., Paunonen, M., Laippala, P., Virtanen, V., 1998. Nurses’ ability to perceive
patients’ fears related to coronary arteriography. Journal of Advanced Nursing
28 (6), 1225e1235.
Idvall, E., 2002. Post-operative patients in severe pain but satisfied with pain relief.
Journal of Clinical Nursing 11 (6), 841e842.
Kain, Z.N., Sevarino, F., Alexander, G.M., Pincus, S., Mayes, L.C., 2000. Preoperative
anxiety and postoperative pain in women undergoing hysterectomy. A
repeated-measures design. Journal of Psychosomatic Research 49 (6), 417e422.
Kehlet, H., Jensen, T.S., Woolf, C.J., 2006. Persistent postsurgical pain: risk factors
and prevention. Lancet 367 (9522), 1618e1625.
Kettwich, S.C., Sibbitt, W.L., Brandt, J.R., Johnson, C.R., Wong, C.S., Bankhurst, A.D.,
2007. Needle phobia and stress-reducing medical devices in pediatric and adult
chemotherapy patients. Journal of Pediatric Oncology Nursing 24 (1), 20e28.
Kruijver, I.P., Garssen, B., Visser, A.P., Kuiper, A.J., 2006. Signalising psychosocial problems in cancer care: the structural use of a short psychosocial checklist during
medical or nursing visits. Patient Education and Counseling 62 (2), 163e177.
Kuball, J., Schutz, Gamm, H., Weber, M., 2004. Bone marrow puncture and pain.
Acute Pain 6, 9e14.
329
Lampic, C., Sjoden, P.O., 2000. Patient and staff perceptions of cancer patients’
psychological concerns and needs. Acta Oncologica 39 (1), 9e22.
Lampic, C., von Essen, L., Peterson, V.W., Larsson, G., Sjoden, P.O., 1996. Anxiety and
depression in hospitalized patients with cancer: agreement in patientestaff
dyads. Cancer Nursing 19 (6), 419e428.
Landis, J.R., Koch, G.G., 1977. The measurement of observer agreement for categorical data. Biometrics 33 (1), 159e174.
Levin, M.L., Berry, J.I., Leiter, J., 1998. Management of pain in terminally ill patients:
physician reports of knowledge, attitudes, and behavior. Journal of Pain and
Liden, Y., Landgren, O., Arner, S., Sjolund, K.F., Johansson, E., 2009. Procedure-related
pain among adult patients with hematologic malignancies. Acta Anaesthesiologica Scandinavica 53 (3), 354e363.
Marks, I., 1988. Blood-injury phobia: a review. The American Journal of Psychiatry
145 (10), 1207e1213.
Marquie, L., Raufaste, E., Lauque, D., Ecoiffier, M., Sorum, P., 2003. Pain rating by
patients and physicians: evidence of systematic pain miscalibration. Pain 102
(3), 289e296.
Martensson, G., Carlsson, M., Lampic, C., 2008. Do nurses and cancer patients agree
on cancer patients’ coping resources, emotional distress and quality of life?
European Journal of Cancer Care 17 (4), 350e360.
Maxwell, A., 1970. Comparing the classification of subjects by two independent
judges. British Journal of Psychiatry 116, 651e655.
McNemar, Q., 1947. Note on the sampling error of the difference between correlated
proportions or percentages. Psychometrika 12, 153e157.
Mollema, E.D., Snoek, F.J., Haine, R.J., van der Ploeg, H.M., 2001. Phobia of selfinjecting and self-testing in insulin-treated diabetes patients: opportunities
for screening. Diabetic Medicine 18 (8), 671e674.
Ozalp, G., Sarioglu, R., Tuncel, G., Aslan, K., Kadiogullari, N., 2003. Preoperative
emotional states in patients with breast cancer and postoperative pain. Acta
Anaesthesiologica Scandinavica 47 (1), 26e29.
Portnow, J., Lim, C., Grossman, S.A., 2003. Assessment of pain caused by invasive
procedures in cancer patients. Journal of the National Comprehensive Cancer
Network 1 (3), 435e439.
Puntillo, K., Neighbor, M., O’Neil, N., Nixon, R., 2003. Accuracy of emergency nurses
in assessment of patients’ pain. Pain Management Nursing 4 (4), 171e175.
Radwin, L.E., 1996. Knowing the patient: a review of research on an emerging
concept. Journal of Advanced Nursing 23 (6), 1142e1146.
Shrout, P.E., Fleiss, J.L., 1979. Intraclass correlations: uses in assessing rater reliability. Psychological Bulletin 86 (2), 420e428.
Sjostrom, B., Dahlgren, L.O., Haljamae, H., 1999. Strategies in postoperative pain
assessment: validation study. Intensive and Critical Care Nursing 15 (5),
247e258.
Sneeuw, K.C., Aaronson, N.K., Sprangers, M.A., Detmar, S.B., Wever, L.D.,
Schornagel, J.H., 1999. Evaluating the quality of life of cancer patients: assessments by patients, significant others, physicians and nurses. British Journal of
Cancer 81 (1), 87e94.
Steedman, B., Watson, J., Ali, S., Schields, M.L., Patmore, R.D., Allsup, D.J., 2006.
Inhaled nitrous oxide (Entonox) as a short acting sedative during bone marrow
examination. Clinical and Laboratory Haematology 28 (5), 321e324.
Vanhelleputte, P., Nijs, K., Delforge, M., Evers, G., Vanderschueren, S., 2003. Pain
during bone marrow aspiration: prevalence and prevention. Journal of Pain and
von Essen, L., 2004. Proxy ratings of patient quality of life-factors related to
patienteproxy agreement. Acta Oncologica 43 (3), 229e234.
Wincent, A., Liden, Y., Arner, S., 2003. Pain questionnaires in the analysis of long
lasting (chronic) pain conditions. European Journal of Pain 7 (4), 311e321.
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one day before BMA, n = 10
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Patients
invited to participate (n = 88)
Could not come earlier for the
BMA, n = 26
Declined participation, n = 8
Randomized,
n = 50
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n = 25
Allocated:
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KarolinsNa Institutet, StocNholm, Sweden

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