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Terapi Musik 1
Terapi Musik 1
Terapi Musik 1
Key Words The effect of music therapy was sustained for up to 8 weeks
Music therapy ⴢ Alzheimer’s disease ⴢ Depression ⴢ Anxiety after the discontinuation of sessions between weeks 16 and
24 (p ! 0.01). Conclusion: These results confirm the valuable
effect of music therapy on anxiety and depression in pa-
Abstract tients with mild to moderate Alzheimer’s disease. This new
Background/Aims: Numerous studies have indicated the music therapy technique is simple to implement and can
value of music therapy in the management of patients with easily be integrated in a multidisciplinary programme for the
Alzheimer’s disease. A recent pilot study demonstrated the management of Alzheimer’s disease.
feasibility and usefulness of a new music therapy technique. Copyright © 2009 S. Karger AG, Basel
The aim of this controlled, randomised study was to assess
the effects of this new music therapy technique on anxiety
and depression in patients with mild to moderate Alzhei- Introduction
mer-type dementia. Methods: This was a single-centre,
comparative, controlled, randomised study, with blinded as- According to a recent study, 24.3 million people cur-
sessment of its results. The duration of follow-up was 24 rently suffer from Alzheimer’s disease or related disor-
weeks. The treated group (n = 15) participated in weekly ses- ders, and 4.6 million new cases are reported worldwide
sions of individual, receptive music therapy. The musical each year. The number of patients is expected to double
style of the session was chosen by the patient. The validated every 20 years, to reach 43.2 million by 2020 and 81.1
‘U’ technique was employed. The control group (n = 15) par- million by 2040 [1]. Alzheimer’s type dementia (AD) is
ticipated under the same conditions in reading sessions. The the most common degenerative disease, with only half of
principal endpoint, measured at weeks 1, 4, 8, 16 and 24, was the cases being diagnosed and one third treated. With the
the level of anxiety (Hamilton Scale). Changes in the depres- 2-fold increase in the number of cases anticipated over
sion score (Geriatric Depression Scale) were also analyzed as the next few decades, this progressive disease has become
a secondary endpoint. Results: Significant improvements in a major public health problem. Alzheimer’s disease is
anxiety (p ! 0.01) and depression (p ! 0.01) were observed in characterised by acquired impairment in cognitive func-
the music therapy group as from week 4 and until week 16. tion, with a gradual impact on the patient’s professional
Patient recruitment
12 weeks
Without music therapy (n = 15)
Clinical evaluations
D0 W4 W8 W16 W24
Fig. 1. Study flow chart.
stable reduced doses. Patients considered highly likely not to com- Thirty patients in total were randomised to one of the 2 groups,
ply with the protocol or to drop out of the study as well as those i.e. 15 patients per group. The subjects were followed up at W4,
suffering from a life-threatening illness during the envisaged W8, W16 and W24 (fig. 1).
study period were not included in the study. Likewise, patients In the group of patients undergoing music therapy, the ses-
with other neurological disorders, stroke, Parkinson’s disease, ep- sions took place once a week between D0 and W16. The patients
ilepsy, Lewy body dementia defined by the presence of extrapyra- in the control group, without music therapy, took part in a differ-
midal symptoms, hallucinations, unexplained episodes of confu- ent type of session (rest and reading), under the same conditions
sion, dementia possibly of vascular origin (modified Hachinski and at the same intervals.
ischaemia score 1 4), frontal dementia (frontal score 1 3) and psy- The results obtained at D0, W4, W8, W16 and W24 were col-
chiatric disorders (schizophrenia, bipolar disorders or depression lected by an independent neuropsychologist assessor (D.L.), not
as per the major depressive disorder criteria of DSM-IV) were not belonging to the care team and unaware of the type of interven-
included in the study. tion. The assessment at W24 made it possible to observe the po-
tential persisting effect of music therapy.
Sample Size
The number of subject required was estimated at 11 per group Intervention Method
for a type I risk of 5% and a power of 90% with a 2-sided hypoth- The individual receptive music therapy method was used.
esis. This sample size was based on the results of the preliminary This may help reduce anxiety, depression and agitation in patients
study [16], taking an improvement corresponding to 7 units (on the suffering from Alzheimer’s disease [19, 20]. The music was chosen
Hamilton Scale) with a standard deviation of 2.6 in the music ther- based on the patients’ personal tastes following an interview/
apy group versus an improvement corresponding to 3 in the con- questionnaire. Choosing music connected to the individual’s per-
trol group (improvement close to the standard deviation). Consid- sonal experience is of paramount importance. The style of music
ering the anticipated number of patients lost to follow-up, the sam- chosen varies from one patient to another, but also from one ses-
ple size for the group was increased to 15 subjects per group. sion to another for a given patient. The Centre Hospitalier Ré-
Thirty subjects in total were included in the context of the study. gional de Montpellier (CHRU) and Association de Musicothéra-
pie Applications et Recherches Cliniques (AMARC) thus de-
Authorised Medication/Concomitant Medication signed a computer program for this purpose. This makes it
All medicinal products and preparations, including over-the- possible to select a musical sequence suited to the patient’s request
counter products, taken by the patient during the study were re- from the different musical styles suggested (classical music, jazz,
corded in the case report form stating the name, dosage, indica- world music, various). The standard musical sequence, lasting 20
tion and treatment duration. min, is broken down into several phases which gradually bring
The intake of medicinal products was recorded at each follow- the patient into a state of relaxation according to the new ‘U se-
up visit. No modifications in medication or significant changes quence’ method [8, 9, 16]. This works by reducing the musical
in medicinal product intake were observed during the study, ir- rhythm, orchestral formation, frequency and volume (descending
respective of therapeutic class and patient group. ‘U’ phase). After a phase of maximum relaxation (bottom ‘U’ seg-
ment), a re-enlivening phase follows (ascending ‘U’ segment)
Method (fig. 2). All of the music sequences, constructed using the ‘U se-
All of the included patients underwent a clinical evaluation quence’ method, were specially created by the record publishing
and neuropsychological assessment at day 0 (D0), week 4 (W4), company, Music Care (table 1).
W8, W16 and W24. This follow-up was carried out in a visit con- The music was streamed via headphones in the patients’
text. Each subject underwent a clinical examination by a neurolo- rooms. The patients were either in a supine position or seated in
gist experienced in the diagnosis of AD, together with a neuro- a comfortable armchair. They were also offered a mask so as to
psychologist, and carried out all of the envisaged tests and ex- avoid visual stimuli, thus encouraging them to concentrate on the
aminations. music.
40 >T > 30
OF: 1–3
Table 1. Choice of suggested music styles ered was drawn up for each group. The quantitative data were
described in terms of sample size, mean, standard deviation and
Classical Jazz World Various range (minimum and maximum). The qualitative data were de-
scribed by their distribution in terms of sample size and percent-
Piano Piano Cuba Popular accordion music age by class. The normality of data was verified using the Kol-
Violin Guitar Andes World accordion music mogorov-Smirnov test. The comparability of the 2 groups was
Flute Saxophone India Classic vocals verified on the baseline data (D0). The means were compared us-
Harp Trumpet Ireland Popular vocals ing Student’s t test or the Mann-Whitney nonparametric test.
Oboe Trombone Spain New age music Qualitative variables were compared with the 2 test or Fisher’s
exact test. A multivariate analysis was performed by means of
ANOVA with repeated measures, in order to study the overall
changes in the endpoints measured during follow-up. The differ-
ences between 2 consecutive time points and between each time
Randomisation
point and D0 were tested. The tests were 2-sided, with a signifi-
The patients were allocated to the different groups by ran-
cance limit of 5%. The statistical analysis was performed using
domisation at the end of the inclusion visit (V0), after patient in-
SAS쏐 software V9.1.
formation, verification of inclusion and exclusion criteria, and
signing the consent form.
Randomisation was generated in blocks of 4 by the method-
ological team (Clinical Research Unit, Montpellier CHRU). Results
Study Endpoints
• The primary study endpoint corresponded to anxiety between Figure 3 illustrates the patient distribution within the
D0 and W16, measured using the Hamilton Scale, with the groups. Two patients were prematurely withdrawn from
total score ranging from 0 to 56 [21, 22]. This scale consists of the study in the intervention group: 1 between W8 and
14 items covering all of the sectors of psychosomatic anxiety. W16 owing to an intercurrent event not related to the
• The secondary endpoints corresponded to depression mea-
sured by means of a score obtained from the Geriatric Depres- study (life-threatening situation, hospitalisation), and
sion Scale (GDS) questionnaire. This is a self-assessment ques- the second died between W16 and W24. Four patients
tionnaire consisting of 30 dichotomous questions, perceived were withdrawn from the study in the control group: 1
as the reference diagnostic tool for evaluating depression in between W4 and W8 due to dropping out, 1 between W4
the elderly. The maximum score is 30 [23]. and W8 owing to an intercurrent event not related to the
Statistical Analysis study (hospitalisation), 1 patient died between W4 and
All of the randomised patients were included in the intent-to- W8, and the last patient dropped out between W16 and
treat population. An overall description of each variable consid- W24.
Excluded patients
n=8
Randomisation
D0
W4 (n = 15) W4 (n = 15)
Patients withdrawn
from study
(drop-out,
Patient withdrawn W8 (n = 15) hospitalisation, death)
W8 (n = 12)
from study
(hospitalisation)
Randomised Comparative Study The data relating to patient clinical examination are
The comparability of the 2 groups was verified at in- described and compared between the 2 groups in table 2.
clusion (table 2) for the main demographic, sociocultural The score for the Hamilton Anxiety Scale, the MMSE
and medical characteristics. score and the GDS score, obtained during the baseline
The 2 groups were comparable at inclusion in terms of visit, are shown. No statistically significant differences
demographic and sociocultural data and history of the are observed between the 2 groups as regards the scores
disease, apart from there being a higher number of wom- obtained for the Hamilton Scale, GDS and MMSE at in-
en in the music therapy group. clusion.
25
*
* * *
20
10
0
D0 W4 W8 W16 W24
Follow-up visits
Value
Anx. W24 13 10.686.3 2/20 11 20.585.4 10/27 <0.001
Variation
D0–W24 13 –11.587.2 –22/–1 11 –1.586.8 –17/9 0.002
W16–W24 13 2.183.7 –4/8 11 –0.882.8 –7/3 0.046
20
p = 0.06
15
GDS score
* **
** *
10
0
D0 W4 W8 W16 W24
Follow-up visits
Value
Dep. D0 15 16.786.2 6/26 15 11.887.4 1/27 NS
Dep. W4 15 13.186.1 5/26 15 12.187.2 4/25 0.046
Dep. W8 15 11.485.0 4/22 12 12.485.6 6/23 0.009
Dep. W16 14 8.983.3 4/14 12 11.286.1 4/25 0.002
Variation
D0–W4 15 –3.584.6 –13/3 15 0.382.8 –3/6 0.04
W4–W8 15 –1.782.8 –7/2 12 0.684.2 –5/8 NS
W8–W16 14 –2.282.7 –9/1 12 –1.385.0 –12/5 NS
D0–W16 14 –7.784.6 –15/–1 12 –0.284.4 –8/6 0.002
Dep. = Depression.
The level of depression decreased further in the music After 16 weeks, the improvement corresponded to ap-
therapy group at W16, 8.9 (83.3) for the intervention proximately 7.7 (84.6) points, i.e. 47.1% in the music ther-
group versus 11.2 (86.1) for the control group. The chang- apy group with a mean depression score of 16.7 (86.2)
es between D0 and W16 appeared to be significantly dif- versus an improvement in the region of 0.2 (84.4) points,
ferent between the 2 treatment groups as regards this i.e. 1.7%, in the control group with a mean depression
endpoint (p = 0.002; table 5). score of 11.8 (87.4).
Value
Dep. W24 13 12.586.4 2/27 11 12.187.6 1/29 0.003
Variation
D0–W24 13 –4.084.6 –12/3 11 1.383.9 –7/8 0.003
W16–W24 13 3.484.4 –3/14 11 0.982.4 –3/5 NS
Persistence of the Effect of Music Therapy at W24. The These results confirm the beneficial effect of music ther-
scores obtained at W24 were compared between the 2 apy on symptoms of anxiety, from the fourth week of
groups. ANOVA with repeated measures evidenced a sig- treatment. The significant intergroup difference ob-
nificant difference (p = 0.006); the 2 groups progressed served between D0 and W24 demonstrates the persistent
in a different manner during follow-up, up to 6 months. effect of music therapy on symptoms of anxiety for up to
Table 6 describes and compares the GDS score ob- 2 months after stopping the sessions (fig. 4).
tained at W24, the difference between D0 and W24, and As regards the depression score (GDS), the 2 groups
also between W16 and W24, with adjustment on D0. The progressed in a different manner between each follow-up
depression score at W24 was 12.5 (86.4) in the music time point. Hence, between D0 and W4, a significant re-
therapy group and 12.1 (87.6) in the control group. The duction was observed in the score for the music therapy
difference between D0 and W24 appeared to be signifi- group, whereas in the group not receiving music therapy,
cant regarding this endpoint (p = 0.03; table 6). the mean score showed a tendency towards a slight in-
crease (fig. 5). Likewise, significant changes between D0
Additional Analyses: Changes in Cognition and W16 were evidenced, together with significant varia-
As regards the MMSE, the score changed from 19.8 tion between D0 and W24. The significant intergroup
(84.4) at D0 to 19.6 (84.4) at W16 in the music therapy difference observed between D0 and W24 tends to show
group and from 20.7 (83.4) at D0 to 19.8 (83.3) at W16 that the effect of music therapy on depression is main-
in the control group. No significant differences were evi- tained for up to 2 months after stopping the sessions
denced between the 2 groups. This result was confirmed (fig. 5).
by ANOVA with repeated measures, conducted on 26 pa- The main results are similar to those observed in the
tients. international scientific literature [4, 24]. Koger et al. [4]
thus carried out a review of the literature combining 69
articles published between 1985 and 1996. This analysis
Discussion reflects a favourable response to music therapy but high-
lights the lack of specific information on the action mech-
This randomised controlled study, the endpoints of anism of this method. The variables used are extremely
which were evaluated under blind conditions, enabled a heterogeneous: music therapy methods, type of music
stringent assessment of the impact of music therapy in therapist professional involved, type of dementia, degree
patients suffering from mild to moderate stages of AD. of cognitive impairment, sample size, etc. Koger et al. [4],
The results obtained over the entire follow-up period Clark et al. [25] and Sherratt et al. [24] also confirmed
show a significant difference between the 2 groups re- these results through reviews of the literature. It is inter-
garding anxiety, the primary study endpoint. Signifi- esting to note that the majority of the concerned studies
cantly different changes were observed between the 2 institutionalised individuals and were mainly conducted
groups between D0 and W4. A reduction in the score was (in two thirds of the cases) in North America [22]. In
thus found for the music therapy group, whereas the 1999, Koger et al. [4] emphasised the lack of published
mean score remained constant in the control group. Sim- randomised controlled studies. Only 1 review of the lit-
ilarly, significant changes between D0 and W8 and be- erature focused on the effect of music therapy on agita-
tween D0 and W16 were evidenced between the 2 groups. tion [5]. Based on the analysis of 7 studies, the author
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