0deec529c7b3b0379c000000 PDF
0deec529c7b3b0379c000000 PDF
0deec529c7b3b0379c000000 PDF
5 May 2013
Original Article
Abstract
Context. Treatment of pain in palliative care patients is challenging. Adjunctive
methods of pain management are desirable. Music therapy offers a nonpharma-
cologic and safe alternative.
Objectives. To determine the efficacy of a single music therapy session to
reduce pain in palliative care patients.
Methods. Two hundred inpatients at University Hospitals Case Medical Center
were enrolled in the study from 2009 to 2011. Patients were randomly assigned to
one of two groups: standard care alone (medical and nursing care that included
scheduled analgesics) or standard care with music therapy. A clinical nurse
specialist administered pre- and post-tests to assess the level of pain using
a numeric rating scale as the primary outcome, and the Face, Legs, Activity, Cry,
Consolability Scale and the Functional Pain Scale as secondary outcomes. The
intervention incorporated music therapist-guided autogenic relaxation and live
music.
Results. A significantly greater decrease in numeric rating scale pain scores was
seen in the music therapy group (difference in means [95% CI] 1.4 [2.0,
0.8]; P < 0.0001). Mean changes in Face, Legs, Activity, Cry, Consolability scores
did not differ between study groups (mean difference 0.3, [95% CI] 0.8, 0.1;
P > 0.05). Mean change in Functional Pain Scale scores was significantly greater in
the music therapy group (difference in means 0.5 ([95% CI] 0.8, 0.3;
P < 0.0001).
Conclusion. A single music therapy intervention incorporating therapist-guided
autogenic relaxation and live music was effective in lowering pain in palliative care
patients. J Pain Symptom Manage 2013;45:822e831. 2013 U.S. Cancer Pain
Relief Committee. Published by Elsevier Inc. All rights reserved.
Address correspondence to: Kathy Jo Gutgsell, RN, 5065, Cleveland, OH 44106, USA. E-mail:
MT-BC, Music Therapy Department, Seidman [email protected]
Cancer Center at University Hospitals Case Medi- Accepted for publication: May 14, 2012.
cal Center, 11100 Euclid Avenue, Mailstop: wrn
2013 U.S. Cancer Pain Relief Committee. 0885-3924/$ - see front matter
Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpainsymman.2012.05.008
Vol. 45 No. 5 May 2013 Music Therapy Reduces Pain in Palliative Care 823
Key Words
Music therapy, pain, palliative care, randomized controlled trial
results need to be interpreted with caution. attended Palliative Care rounds. The investiga-
The criteria assessed for risk of bias were ran- tor received daily referrals for patients with ad-
dom sequence generation, allocation conceal- vanced, potentially life-limiting illness who
ment, blinding of participants and personnel, were in pain from the Palliative Care Team
blinding of outcome assessment for objective and from Nursing Services. The UHCMC did
and subjective outcomes, incomplete outcome not have a dedicated Palliative Care Unit
data, selective reporting, and other biases. The when the study was being conducted. The Pal-
main reason for receiving a rating of high risk liative Care Team provides consultative services
of bias was the lack of blinding. Blinding is of- for patients throughout UHCMC in intensive
ten impossible in music therapy and music care, general medical, surgical, rehabilitation,
medicine studies that use subjective outcomes and oncology units.
such as pain. This is especially true for music After the initial referral, the investigator
therapy studies that use active music making. conducted a chart review and interviewed the
When participants cannot be blinded to the in- participant and his or her nurse to determine
tervention, there is an opportunity for bias if the following inclusion criteria were met:
when they are asked to report on these subjec- 1) a diagnosis of advanced, potentially life-
tive outcomes. Therefore, it appears impossi- limiting illness, 2) 18 years or older, 3) pain
ble for these types of studies to receive a low of three or greater as measured on a zero to
or even moderate risk of bias even if all other 10 numeric rating scale (NRS), 4) able to un-
risk factors (e.g., randomization, allocation derstand English, and 5) alert and oriented
concealment, and so on) have been adequately to person and place and able to rate pain on
addressed.13 the numeric scale. Patients were not excluded
Analysis of the 2011 Cochrane review reveals if they were on scheduled pain medications,
that music therapy interventions used in re- although interventions were scheduled around
search varied in frequency (single to multiple the administration of breakthrough pain
in number), length (20e120 minutes), live medications, with the intervention occurring
vs. recorded music, patient- vs. therapist- immediately before the next dose of medica-
selected music, and the intervention itself (in- tion. The UHCMC Institutional Review Board
teractive music making with the participants, approved the study. The investigator obtained
music-guided imagery, music-guided relaxa- written informed consent from all participants.
tion, and music-video making). Palliative care
music therapy needs more rigorous research Outcome Measures
so that interventions are evidence based.14 To Primary Outcome: NRS. The NRS is validated
better understand the impact of specific music for use in adults and children aged nine years
therapy interventions, studies are needed that or older in all patient care settings who are
isolate the effects of one intervention.3,15 The able to use numbers to rate the intensity of
authors of the Cochrane review note as well their pain. It is recommended in the literature
that most studies are compromised by small to measure short-term changes in pain and it is
sample size and lack of statistical power.12 used throughout UHCMC.16 Patients rate
The objective of the present study was to de- their pain from zero to 10, with zero reflecting
termine the efficacy of a single music therapy no pain and 10 reflecting the worst possible
session to reduce pain in palliative care patients. pain.17
validated in children with postoperative pain, the CNS. Randomization assignments were
the FLACC Scale has been recently validated generated using SAS software (SAS Institute,
in assessing pain in critically ill adults who are Inc., Cary, NC) by the study statistician, using
unable to self-report pain. Because Voepel- a permuted block scheme with random block
Lewis et al.19 and others found that FLACC sizes of 20 or 30. Because the protocol speci-
scores were comparable with those of the com- fied the presence of a music therapist to facil-
monly used NRS, the authors selected this itate the music therapy intervention, it was not
pain assessment to provide the behavioral com- possible for the participant to be blinded to his
ponent of the patients pain experience. In ad- or her group assignment. If the participants
dition, the FLACC Scale was shown to have pain was less than three on the NRS, he or
excellent interrater reliability, criterion validity, she was excluded from the study.
and construct validity. Health care professionals
who are trained in its use are qualified to per- Music Therapy Group. The investigator, a pro-
form the assessment. Because the FLACC Scale fessional music therapist, informed the patient
has not been validated in adults who are able to of his or her assignment to the music therapy
self-report pain, the present study used the group and then proceeded with the interven-
FLACC Scale as a secondary outcome. tion. After placing a Do Not Disturb sign
on the door and preparing the patient and
Secondary Outcome: The Functional Pain Scale. the environment (adjusting the lights, offering
Patients are asked if their pain is tolerable or a blanket, turning off cell phones, and so on),
intolerable. From there, they describe whether the therapist briefly played the ocean drum to
or not pain keeps them from engaging in daily give the patient the choice of whether or not
activities. A rating of zero reflects no pain. A to include it in the intervention because
rating of one indicates tolerable pain with no some patients express aversion for it and find
impact on activity. A rating of five reflects intol- that it inhibits their ability to relax. The thera-
erable pain with a resulting inability to verbally pist then facilitated a single 20-minute music
communicate.20 The Functional Pain Scale therapy intervention directed at lowering
(FPS) assesses both the patients subjective per- pain. The intervention, a standard protocol
ception of pain and its impact on his or her for all participants, began with verbal instruc-
level of functioning. Although the FPS was de- tions for autogenic relaxation. The music ther-
veloped to determine pain in older people apist asked the patient to pay attention to
who are cognitively intact, the authors selected breathing for approximately one minute.
it as a secondary outcome for the present study Then the therapist led the patient in autogenic
because of its ability to help professionals un- muscle relaxation by asking the patient to pay
derstand how pain affects daily functioning attention to the scalp muscles and allow them
in all their adult patients. to release, and moving down with similar focus
on specific muscle groups, ending with the
Intervention feet. Next, the patient was invited to imagine
After the investigator obtained informed a safe place of his or her own choosing. The
consent from an eligible participant, the inves- therapist asked the patient to imagine what
tigator summoned a clinical nurse specialist he or she saw, smelled, heard, tasted, and felt
(CNS) research assistant who assessed the pa- on the skin at the safe place. Then the music
tients pain using the three measures: the therapist informed the patient that she would
NRS, the FLACC Scale, and the FPS. The begin to play first the ocean drum, if chosen,
CNS then left the hospital unit. If the partici- and then the harp to support his or her explo-
pants pain score was still three or greater on ration of the safe place. The therapist played
the NRS, the investigator immediately thereaf- the same harp pieces for every patient. The
ter opened a serially numbered, sealed, opa- pieces for the present protocol were chosen
que envelope to obtain the patients assigned based on the therapists clinical experience
group. The investigator opened the sealed en- in which patients had described them as sooth-
velope containing group assignment (music ing, peaceful, and calming. All pieces were
therapy or control) in the presence of the pa- played at a soft volume in a slow tempo and
tient but not the CNS to ensure blinding of are described as follows: 1) an improvisation
826 Gutgsell et al. Vol. 45 No. 5 May 2013
in the mode of G Mixolydian with a duple me- immediately before and after the music therapy
ter, 2) four precomposed pieces in the key of C or control intervention. Each study participant
Major that can be described as light classical was assessed by the same CNS pre- and postin-
and are unfamiliar to most listeners: An- tervention. In all but four cases, post-test data
dante by Waddington in duple meter, Pass- were obtained within 10 minutes of completion
ing By and Reverie by Grandjany in duple of the intervention. On three occasions, the
meter, and Barcarolle by Grandjany in triple CNS obtained post-test data in 15 minutes
meter. At the conclusion of the music, the ther- and on one occasion in 30 minutes because
apist gently invited the participant to leave his of schedule conflicts. For 11 patients, blinding
or her imagined safe place and re-enter the of the research assistant was broken because
hospital room, realizing that the safe place is the patients revealed their group assignment.
a resource to which he or she can return at To attempt to control for bias, the therapist
any time. Then the music therapist left the remained outside the room while the research
room and notified the same CNS to return to assistant administered pre- and post-tests to
the patient to reassess pain using the same the patient.
three measures: the NRS, the FLACC Scale,
and the FPS. After completion of the post- Statistical Analysis
tests, the therapist re-entered the patients Comparisons of baseline characteristics be-
room to verbally process the music therapy in- tween groups were made using t-tests or Wil-
tervention and offer follow-up treatment. She coxon rank sum tests for continuous
gave each study participant a CD of the inter- variables, and c2 tests for categorical or binary
vention for future use and provided a CD variables. The mean changes from pre- to post-
player on request. Interested readers may con- test in each of the three pain scales (NRS,
tact the investigator to request a recording of FLACC Scale, and FPS) were compared be-
the intervention. tween the music therapy and control groups
using an independent sample t-test. Two-way
Control Group. The therapist informed the pa- analysis of variance was used to examine
tient of his or her assignment to the control whether treatment effects differed according
group and explained that he or she would to patient characteristics such as age, gender,
receive the live music therapy intervention af- and baseline pain level. All tests were two-sided
ter reassessment for pain. Next, she facilitated with a significance level of 0.05. Statistical
the same comfort measures as for the music analyses were carried out using SAS version
therapy group: adjusting the lights, providing 9.2. Because there was a single primary out-
a blanket, and turning off the telephones. come, no adjustment was made for multiple
Then the therapist invited the patient to relax, comparisons.
but gave no special instructions for doing so The sample size of 200 (100 per treatment
because the therapist-guided autogenic relaxa- arm) provided 80% power to detect between-
tion was integral to the music therapy interven- group differences in mean post-test numeric
tion. She left the room and placed a Do Not pain scores of 0.40 standard deviations, using
Disturb sign on the door. After 20 minutes, a two-sided test with a significance level of
she notified the same CNS to return to the pa- 0.05. The sample size of 100 per group was
tient to reassess pain using the three measures: chosen partly on the basis of what was a feasible
the NRS, the FLACC Scale, and FPS. After number to study and was justified by determin-
post-test data were collected, the therapist pro- ing that it would provide 80% power to detect
vided the music therapy intervention for each an effect size of 0.40 standard deviations,
control patient. The therapist gave each pa- which is in-between what Cohen21 considers
tient in the control group a CD of the interven- a small and a medium effect size (0.2
tion for future use and provided a CD player and 0.5, respectively). We thus determined
on request. that this effect size was suitably low to justify
the sample size. Primary analyses were carried
Data Collection Procedure out using intention-to-treat analysis, including
The CNS, blinded to treatment allocation, all randomized patients on whom data were
administered the pain assessment measures obtained. Statistical analysis of the final data
Vol. 45 No. 5 May 2013 Music Therapy Reduces Pain in Palliative Care 827
excluding: 1) the 11 patients who divulged be wakened for the post-test. The subjects as-
group assignment to the CNS, 2) the four pa- signed to music therapy and control groups
tients who had post-test assessments for more did not differ according to gender, ethnicity, di-
than 10 minutes after the intervention, and agnosis, mean age, or baseline pain severity
3) the 10 patients who chose not to hear the (Table 1). The pain duration variable had
ocean drum and the one patient who re- a skewed distribution in both groups, which is
quested to skip the talk and get right to the why the authors used a nonparametric Wilcox-
music, did not alter the results. on rank sum test to compare the groups at base-
line. Because the median is a better measure of
location than the mean for these data, we added
the median pain duration to Table 1 for this var-
Results iable. Note that the medians of the two groups
are quite similar, reflecting the nonsignificant
Of the 400 referred patients, 200 signed in-
P-value from the rank sum test.
formed consent and were enrolled in the study
(Fig. 1). Of the 200 subjects screened but not
enrolled, 20 were ineligible and 180 did not Numeric Rating Scale
give consent. Reasons for ineligibility included Both music therapy and control groups
pain score less than three (n 15), not oriented showed significant declines from pre- to
to person and place (n 3), did not speak En- post-test (mean change [95% CI] 1.94
glish (n 1), and researcher error (n 1). [2.37, 1.52] for music therapy and 0.56
The 180 subjects who did not consent gave var- [0.92, 0.19] for control). However, a signifi-
ious reasons including I want to be alone now, cantly (P < 0.0001) greater change was seen in
It is a bad day, I do not like the harp, I am the music therapy group (difference in means
not interested, Music cannot help my pain, [95% CI] 1.39 [1.95, 0.83]).
I brought my own music to listen to, or Music
is not my thing. Of the 100 subjects assigned to Face, Legs, Activity, Cry, Consolability Scale
the music therapy group, all but one completed The FLACC Scale scores declined signifi-
the music therapy session and completed all cantly in both the music therapy and control
measurements. The patient who did not com- groups. However, the mean change in scores
plete the post-test exhibited symptoms of confu- did not differ significantly between the two
sion and agitation during the intervention and groups (difference in means [95% CI] 0.3
was excluded from the study. Of the 100 sub- [0.8, 0.1], P > 0.05).
jects in the control group, all completed the
pretest. Postintervention scores were obtained Functional Pain Scale
on 99 subjects. One control patient who had There was a significant decline in the func-
been in severe pain fell asleep during the con- tional pain score in the music therapy group,
trol session. His nurse requested that he not but not in the control group. The mean
Table 1
Demographic Variables of the Study Participants
Study Group
Age (mean SD) 56.09 15.08 57.45 14.76 54.72 15.34 0.20a
Gender, n (%)
Male 62 (31) 31 (31) 31 (31) >0.999b
Female 138 (69) 69 (69) 69 (69)
Race, n (%)
White 135 (67.5) 66 (66) 69 (69) 0.65b
Nonwhite 65 (32.5) 34 (34) 31 (31)
Diagnosis, n (%)
Cancer 174 (87) 91 (91) 83 (83) 0.09b
Noncancer 26 (13) 9 (9) 17 (17)
Pain severity (mean SD) 6.44 1.82 6.48 1.68 6.39 1.95 0.73a
Pain duration (wk)
Mean SD 14.04 36.83 8.49 14.50 19.58 49.54 0.51c
Median 4.00 3.50 4.00
a
P-value from t-test.
b
P-value from c2 test.
c
P-value from Wilcoxon rank sum test.
100
99
99
The GIM uses Western classical music because
N
of therapeutic value.23
Mandel et al.24 found that cardiac rehabilita-
tion patients who listened to prerecorded in-
strumental music interspersed with spoken
suggestions at home for at least three months
NRS numeric rating scale; FLACC Face, Legs, Activity, Cry, Consolability Scale; FPS Functional Pain Scale.
100
99
99
N
100
99
99
99
N
Difference from
post to pre
Post
Pre
Pre
of inquiring about pain and then instructing were obtained within 10 minutes of the com-
the patient to relax is in some instances enough pletion of the music therapy session. On three
to lower pain significantly, as long as it includes occasions the CNS obtained post-test data in
offering to make adjustments to the environ- 15 minutes and on one occasion in 30 minutes
ment such as turning down the lights, pulling as a result of schedule conflicts; 2) address
the window shades, supplying a blanket, turn- whether patients request fewer breakthrough
ing off cell phones, reassuring the patient that pain medications after music therapy; 3) find
someone will reassess his or her pain in 20 min- out whether successive interventions have a
utes, and putting a Do Not Disturb sign on the cumulative pain-lowering effect; 4) examine
door to ensure privacy. whether a therapist-created recording of an in-
Although all attempts were made to mini- tervention has the same pain-lowering effect if
mize risk of bias, two risks remained, which the patient listens to it after a live session with
are implicit in music therapy research. The the same therapist; and 5) address whether
first is the blinding of participants and person- pain is lowered in control group patients who
nel. Because music therapy requires the pres- later receive music therapy.
ence of the music therapist, both the The strengths of the present study are its
therapist and the patient were not blinded to large sample size, its use of one music therapy
group assignment. The second risk is the intervention, and its attempt to meet scientific
blinding of outcome assessment. When partic- standards of a quality randomized controlled
ipants cannot be blinded to the intervention, trial. Because of these features, it provides
there is definitely an opportunity for bias a valuable addition to the literature. Based
when they are asked to report on subjective on the results, palliative care clinicians may
outcomes such as pain.13 confidently refer trained music therapists to
A limitation of the study is that it may be dif- treat pain in this vulnerable population.
ficult to generalize the results to all palliative
care patients in pain, as 45% of the referred
patients did not consent to participate. For Disclosures and Acknowledgments
consenting patients who choose to be less ac- This research was supported by a grant from
tively involved in a music therapy session, the the Kulas Foundation in Cleveland, Ohio. The
intervention used in this study has clinical sig- authors declare no conflicts of interest.
nificance. Further research is needed to repli- The authors would like to thank the Kulas
cate the study so that its results may be Foundation, all of the patients who partici-
generalized to other music therapists and mu- pated in the study, the Clinical Nurse Special-
sical instruments. ists who assisted in gathering data, the Core
Additional research also is needed to: 1) Library, and the Art and Music Therapy De-
measure the length of time pain is reduced af- partment at University Hospitals Case Medical
ter a music therapy intervention. In the pres- Center for its support and encouragement
ent study, in all but four cases, post-test data throughout the study.
Vol. 45 No. 5 May 2013 Music Therapy Reduces Pain in Palliative Care 831
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