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ORIGINAL ARTICLE
788 Deutsches Ärzteblatt International | Dtsch Arztebl Int 2015; 112: 788–94
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Methods OPS, Classification of Operations and Procedures (the German modification of the International Classifica-
The study was conducted at the university affiliated tion of Procedures in Medicine); ICD, International Classification of Diseases
Palliative Care Unit at St. Vincentius Hospital, Heidel-
berg. It was approved by the ethics committee of the
Faculty of Medicine of Heidelberg University (appro-
val no. S-406/2012) and entered in the German Clinical (HRV) measurement. Five minutes later, he left the
Trials Register (DRKS, Deutsches Register Klinischer room. The music therapist then began a short mindful-
Studien) under number DRKS00006137. ness exercise, accompanied by soft monochord sounds.
Taking account of the patient’s breathing pattern, the
Study design volume, dynamics, and intensity of the monochord
This intervention study was conducted as a randomized playing were then increased, and vocal improvisation
controlled trial. Patients who met the criteria listed in was begun in Ionian or Mixolydian mode (see [26] for
Table 1 and were thus eligible to participate in the study an overview of church modes). Towards the end of the
were informed of what the study would involve. Those improvisation, which lasted approximately 15 minutes,
who were willing to participate signed an informed intensity was gradually reduced. In a five-minute
consent form. Both intervention arms (music therapy discussion after the procedure, the patient had the op-
and control) were presented to the participants as portunity to reflect on his or her experience of listening
equally effective relaxation exercises throughout the to the music. The therapist then left the room. The study
study. The participants were therefore blinded to the assistant returned to take post-intervention scores on
study hypotheses. No further blinding methods (of the self-assessment scales and to measure heart rate
therapists or assessors) could be implemented. Follow- variability. This intervention was repeated two days
ing a baseline assessment of quality of life and previous later (eFigure 3).
experience with relaxation techniques, participants Patients in the control group underwent an interven-
were allocated to one of the two study groups using tion of the same duration but with no musical content or
sealed, sequentially numbered envelopes provided by therapeutic relationship. This consisted of a 20-minute
the study assistant. Individuals providing primary treat- excerpt from the Mindfulness-Based Stress Reduction
ment were not involved in this process. The allocation (MBSR) Program, played through headphones (27).
sequence was compiled before the beginning of the MBSR is a training program that lasts several weeks
study, using computerized block randomization (block and has shown evident health benefits (28). The body-
size: 6). Next, two 30-minute sessions were given two scan meditation exercise used provided an active
days apart (eFigure 1). control condition: a moderately relaxing but not
specifically therapeutic effect was expected. The study
Intervention assistant remained silent in the patient’s room during
The relaxation exercise in the experimental group was this process in case the patient had any questions or
conducted by trained music therapists according to a wished to halt the treatment.
standardized procedure, involving voice as well as
music played live on a monochord (eFigure 2). A Measuring methods
monochord is an instrument developed for therapeutic Participants’ self-assessments before and after each
purposes. It has a rectangular wooden body with 24 session served as the primary endpoint. Visual analog
strings tuned to the same note. When played steadily, it scales (VAS) ranging from 0 to 10 were used for sub-
produces a sound rich in overtones and creates a jective assessment of relaxation, general well-being,
soothing atmosphere. Initial pilot studies show subjec- and acute pain. Previous studies had demonstrated that
tive and physiologically detectable relaxation visual analog scales showed adequate psychometric
responses in oncology patients as a result of listening to properties for measurement of acute pain (29).
the sounds of a monochord/tambura (23–25). Throughout the session, intervals in milliseconds
First, the study assistant took baseline scores on self- between successive heartbeats were continuously
assessment scales and began heart rate variability recorded using photoplethysmography (Nexus Blood
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TABLE 2
Volume Pulse Sensor, 128 SPS). Heart rate variability determined using chi-square tests and t-tests for inde-
is an indicator of autonomic nervous system function pendent samples. Differences between sessions 1 and 2
(30). Based on the observation that a healthy heart were analyzed using paired sample t-tests. The study
rhythm has no static phase but rather results from hypotheses were tested using analyses of covariance
dynamic interaction between ascending and descending (ANCOVA), with the pre-intervention score as covari-
neural pathways, heart rate oscillation is used to draw ate and the post-intervention score as the dependent
inferences on the cardiovascular activity of the variable (visual analog scale scores and heart rate
autonomic nervous system (31). Short-term, high- variability measurements were averaged across the two
frequency (HF) changes, such as respiratory sinus sessions if there were no significant differences
arrhythmia, are controlled in particular through vagus between sessions). Physiological data that were not
nerve pathways and can therefore be traced back to normally distributed at baseline were log-transformed
parasympathetic activity (30). Low heart rate variabil- for further analysis. For calculation of the number
ity is a risk factor in cardiovascular (32) and oncologi- needed to treat (NNT), success was defined as a 30%
cal diseases (33, 34), and studies have found it to be a improvement. For intention-to-treat analysis, incom-
predictor of mortality (35). In addition, low heart rate plete datasets were completed using the last observa-
variability as an index of emotional dysregulation is as- tion carried forward method. Where there was no out-
sociated with a range of psychiatric and psychosomatic come-relevant data at any time point, the baseline
illnesses (36). group mean was imputed as a null effect for both pre-
For the present analysis, time segments of five min- and post-intervention scores. The results were then
utes before and after the intervention were compared. tested for robustness in sensitivity analyses (complete
In addition, the mean amplitude of peripheral blood case analysis, CCA). For the three primary endpoints of
volume flow (BVP-A) was calculated for the same time the study (visual analog scales), the Bonferroni correc-
frame. High amplitude implies high blood flow in the tion was used to account for multiple comparisons, re-
fingertips and thus lower sympathetic activity (37). sulting in α = 0.017. For further analyses type I error
Medium-term effects of the intervention were inves- probability was set at α = 0.05. The software packages
tigated by gathering information on quality of life using Biotrace+, Kubios 2.1, and IBM SPSS Statistics 20
the EORTC QLQ-C15-PAL questionnaire at initial were used for data analysis. Sample size calculation
contact and at the end of the second session. EORTC and other details on the methods described here can be
QLQ-C15-PAL consists of 15 items and 10 subscales. It found in the published study protocol (39).
is a short version of QLQ-C30, which is in widespread
use in cancer research, adapted and validated for Results
palliative care (38). Sample description
The primary endpoint (completion of a full session, in-
Statistical analysis cluding visual analog scale data) was achieved by 78 of
Descriptive sample statistics included means, standard the 84 participants. Complete psychometric datasets
deviations, and frequencies. The comparability of the (completion of both sessions with complete visual
two study groups before the beginning of the study was analog scale and quality of life information; eFigure 4)
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TABLE 3
were available in 68 cases. Analysis of physiological (BVP-A), there was an insignificant trend towards
variables included the data of 76 patients. greater vasodilation in the experimental group
The mean age of patients was 63.0 (± 13.4) years, (p = 0.07) (Figure 2).
and 71.4% of them were female. The most common Additional analyses investigated differences in the
primary diagnoses were breast cancer (n = 17), pancre- subscales of the quality of life questionnaire. eFigure 5
atic cancer (n = 11), ovarian cancer (n = 7), and prostate shows that between the beginning and end of the study
cancer (n = 6). With two exceptions, all patients were there were improvements on the overall quality of life
suffering from malignant tumor diseases. Before the scale in both study groups. The improvements were
beginning of the study there were no significant greater in the experimental group, but the difference be-
differences between the groups in terms of age, sex, tween the groups was not significant (p = 0.14). Music
diagnosis, functional level, or interest in relaxation therapy was found to be superior in terms of the fatigue
exercises (eTable). subscale (p = 0.03). Further descriptive trends in the ex-
pected direction were found for the constipation
Primary endpoints (p = 0.13) and physical function (p = 0.14) scales.
Table 2 provides an overview of means, standard devi- There were no further effects in other areas.
ations, and results of analysis of covariance. Because According to CCA sensitivity analyses, the effect on
the effects did not differ significantly between the two fatigue failed to reach statistical significance (p = 0.07).
sessions (p >0.05), mean values were used for further All other test decisions were robust in terms of vari-
analysis. Self-rated relaxation and well-being scores ations related to missing data analysis.
showed significantly greater increases in the music
therapy group compared to the control group (p <0.001 Discussion
and p = 0.013 respectively). Figure 1 shows box-and- The primary hypothesis of this study is supported by
whisker plots comparing changes in the primary end- the results: music therapy improved subjective
points for the two groups. Number-needed-to-treat assessment of relaxation and well-being in termin-
analysis revealed that for one person to have a ally ill patients receiving palliative care. The effect
favorable outcome it was necessary to administer music sizes between the groups were medium to high
therapy to 2.80 and 5.25 patients (for relaxation and (Table 3). This finding is supported by both the sig-
well-being respectively). There were no significant nificant increase in high-frequency (HF) variations
differences in pain perception between the groups in heart rate and a trend towards greater peripheral
(p = 0.53). Table 3 shows mean between-group differ- blood flow, which suggests increased parasympa-
ences and effect sizes. thetic modulation and reduced sympathetic modu-
lation of cardiovascular activity of the autonomic
Secondary endpoints nervous system. Because physiological data varied
Analysis of physiological data showed a significantly greatly between individuals, additional growth curve
greater increase in high-frequency (HF) changes in modeling is planned.
heart rate variability in the music therapy group The hypothesis that music therapy contributes to
(p = 0.01). In terms of peripheral blood volume flow pain reduction was not confirmed. Examination of
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Box-and-whisker FIGURE 1
On the fatigue subscale the observed differences
plots showing were statistically significant; this is concordant with the
changes in VAS findings of a recent pilot study involving breast cancer
changes in phy-
siological data Group: Because study patients were not informed as to
middle line (bold), 2.0 CG which of the two interventions was the experimental
MT
median; colored condition and which the control, they were blind with
rectangle, 25th to regard to the study hypotheses. For organizational
1.0
75th percentile; reasons, no further blinding procedures (for the music
whiskers, upper/
therapist or study assistant) were possible. In a total of
lower quartile;
points, outliers; as-
0.0 78 music therapy sessions, only one (1.3%) was halted
terisks, extremes. due to pain/anxiety on the part of the patient (eFig-
HRV, Heart rate ure 4). This fact suggests high acceptance and low
−1.0
variability; levels of side effects.
MT, music therapy; This study is the first randomized controlled trial to
CG, control group; −2.0 examine objective data for evidence that receptive
HF, power in high- music therapy has an effect on well-being and
frequency spectrum
relaxation in patients receiving palliative care. The
(autoregressive); −3.0 tested relaxation exercise can be used effectively by
BVP-A, blood
volume pulse
HF BVP-A music therapy practitioners in their work with seriously
amplitude and terminally ill patients. Because more data has be-
come available in recent years (10, 20), review articles
should re-examine the available evidence on the
efficacy of music therapy (2, 3).
baseline values shows that many participants were al-
ready being treated well for pain before the beginning Acknowledgement
of the study. In other studies that did find evidence We would like to thank Gisela Platzbecker, Josien van Kampen, and Kerstin
of an analgesic effect for music therapy, recruitment Röbig for their support in conducting the music therapy sessions.
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Corresponding author:
Dipl.-Psych. Marco Warth, M.A.
Zentrum für Schmerztherapie und Palliativmedizin
Klinik für Anästhesiologie, Universität Heidelberg
Im Neuenheimer Feld 131
69120 Heidelberg, Germany
marco.warth@hochschule-heidelberg.de
@ Supplementary material:
eFigures, eTable:
www.aerzteblatt-international.de/15m0788
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Recruitment
Inclusion/exclusion criteria
Informed consent
Baseline measurement:
Interview to take clinical history
T0
Quality of life
Medical records
Randomization
(same day)
HRV, HRV,
quality of life quality of life
Foto: Gülay Keskin
I Deutsches Ärzteblatt International | Dtsch Arztebl Int 2015; 112: 788–94 | Supplementary material
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Introduction,
VAS/HRV before breathing exercise, VAS/HRV after
body scan/mindfulness exercise
eTABLE
Deutsches Ärzteblatt International | Dtsch Arztebl Int 2015; 112: 788–94 | Supplementary material II
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Randomized (n = 84)
III Deutsches Ärzteblatt International | Dtsch Arztebl Int 2015; 112: 788–94 | Supplementary material
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after)
70 Group: middle line (bold), median; colored rect-
CG angle,25th to 75th percentile; whiskers, up-
50 MT
per/lower quartile; points, outliers; aster-
isks, extremes.
30 MT, music therapy; CG, control group;
QL, overall quality of life; FA, fatigue
10
−10
−30
−50
−70
QL FA
Deutsches Ärzteblatt International | Dtsch Arztebl Int 2015; 112: 788–94 | Supplementary material IV