Brief description of trial (Data source: BASEC)
Die Studie untersucht die Wirkung von Musiktherapie auf Angstbeschwerden bei Menschen mit Multipler Sklerose. Ausserdem untersuchen wir Effekte von Musiktherapie auf Depression, Stress, Müdigkeit ("Fatigue"), Lebensqualität, geistige Leistungsfähigkeit und Hautempfinden.
Diese Studie wird mit einer Musiktherapiegruppe und einer Kontrollgruppe durchgeführt, mit jeweils 30 Patienten (insgesamt 60). Musiktherapie ist ein Zweig der Kunsttherapie, in welcher Musik gezielt therapeutisch eingesetzt wird. In dieser Studie ist ein Entspannungs-förderndes Setting vorgesehen, mit live-Musik von einer Musiktherapeutin auf einem Monochord («Behandlungsmonochord»). Dies ist ein Instrument aus Holz mit einer grossen Auflagefläche, auf die man sich legen kann. Darunter aufgespannt sind Saiten, deren Schwingungen die teilnehmende Person nicht nur hören, sondern auch am Körper spüren kann.
Es wird zufällig ausgewählt, in welche Gruppe die Teilnehmer kommen.
Health conditions investigated(Data source: BASEC)
Multiple Sklerose
Health conditions
(Data source: WHO)
Multiple sclerosis
G35.1
G35.2
G35.3;G35.1;G35.2;G35.3
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
In der Musiktherapiegruppe bekommen alle Teilnehmenden 6 Sitzungen bei der Musiktherapeutin, 1x/ Woche. Während der Sitzung liegt die teilnehmende Person auf dem Instrument «Behandlungsmonochord» und entspannt zu der live durch die Therapeutin gespielten Musik dieses Instruments (ca. 15 min).
In der Kontrollgruppe bekommen alle Teilnehmenden ebenfalls 6 Sitzungen bei der gleichen Musiktherapeutin, 1x/Woche. Während der Sitzung liegt die teilnehmende Person auf dem Instrument «Behandlungsmonochord» und entspannt, ohne dass Musik gespielt wird (ca. 10-15 min).
Interventions
(Data source: WHO)
Group 1: Intervenion group: 6 weekly music therapeutic sessions of approximately 45 minutes. Lying 15 minutes on the Monochord, while the music therapists plays the instrument. Introductory ans closing talk of 5-10 minutes with the music therapist.
Group 2: Control group: The same procedures as the intervention group with the following exeption: Relaxing ca. 10-15 minutes while lying on top of the Monochord, without music.
Participants of the active control group will receive vouchers for 6 music-therapy sessions after study end.
Criteria for participation in trial
(Data source: BASEC)
1) Diagnose von schubförmiger oder progredienter Multipler Sklerose
2) Alter > 18 Jahre
3) Gehfähigkeit von mind. 5m mit beidseitiger Hilfe (EDSS ≤ 6.5)
Exclusion criteria
(Data source: BASEC)
1) aktuell schwere psychiatrische Erkrankung, z.B. schwere Depression
2) aktive MS-Erkrankung mit Schüben (innerhalb der letzten 3 Monate, bzw. >2 im letzten Jahr)
3) Veränderung der Medikation innerhalb der letzten 3 Monate (für MS, Depression, Angstsymptome, Müdigkeit, Schmerz oder geistige Leistungsfähigkeit)
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: None
Minimum age: 18 Years
Inclusion criteria: 1)Diagnosis of relapsing-remitting MS (RRMS) or progressive (primary or secondary) MS
2)age >18ys
3)EDSS score of = 6.5
4)Written consent for participation in the study.
Background knowledge about music is not a prerequisite for study participation, but no exclusion criterium either.
Exclusion criteria: 1)Reported or medically recorded diagnoses of current serious psychological disorders including acute and severe depression, suicidality and severe anxiety syndromes
2)Other currently life-threatening or severely disabling physical disorders
3)>2 MS relapses within the last year
4)MS relapse within the last 3 months before recruitment
5)MS immune modulating medication altered within the last 3 months
6)Symptomatic MS medication for depression, anxiety, fatigue, pain or cognition altered in the last 3 months
7)Pregnancy (due to many possible pregnancy-related/hormonal changes in our primary and secondary outcomes)
8)Inability to lie supine for 15 min
9)Severely compromised hearing (unless patient has sufficient hearing aid)
10)Severe numbness in both hands, MS related or due to other causes.
Specifically vulnerable patient groups will not be included.
-
Further information on trial
Date trial registered
Mar 15, 2021
Incorporation of the first participant
May 5, 2021
Recruitment status
Complete
Academic title
(Data source: WHO)
Effects of Receptive Music Therapy with a Monochord in multiple sclerosis (MUTIMS) ? a randomized controlled study - MUTIMS
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: treatment
Phase
(Data source: WHO)
4
Primary end point
(Data source: WHO)
Change in anxiety as measured by the anxiety subscale of The Hospital anxiety and Depression Scale (HADS-A). Timepoints: Baseline, before the second, forth and sixth music-therapeutic session as well as at follow-up 8 weeks after study end. Hypothesis: Receptive music therapy with the Monochord can reduce anxiety by 2.5 points on the HADS-A.
Secundary end point
(Data source: WHO)
Depression: HADS, Subscale Depression (HADS-D);
Fatigue: Modified Impact Scale (MFIS);
Stress perception: Perceived Stress Questionnaire 20 (PSQ20);
Quality of life: Short Form 36 (SF-36);
Cognition: Symbol Digit Modality Test (SDMT);
Thresholds for perception of pain, heat, cold, pressure and mechanical pain: Quantitative sensory testing (QST);
Well-being: Pre-post-questionnaire before und after each session.
All secondary endpoint will be measured at study start (baseline) and study end (study completion).
HADS-D will be assessed additionally before the second, fourth and sixth session and at follow-up.
Contact information
(Data source: WHO)
Universit?tsspital Basel
Trial results
(Data source: WHO)
Results summary
Currently, the analysis is ongoing and the results are being prepared for publication. Preliminary results can be summarized as follows:
We included 57 patients from the MS center in Basel (age: 50.1 ? 12.4 years, sex: 47 women, disease course: 46 relapsing-remitting, median Expanded Disability Status Scale (EDSS) 3.0 (1.0 - 6.5), disease modifying treatment: 53). Patients were randomized 1:1 to two groups: 30 to the MT group (MTG) and 27 to the control group (CG). Patients in the MTG had six weekly sessions of MT, relaxing on top of the ?monochord? instrument and perceiving its music played by the therapist, while patients in the CG had the same number of sessions (lying on the ?monochord?) without music. A blinded rater assessed the endpoints with standardised questionnaires (Hospital Anxiety and Depression Scale, HADS; Modified Fatigue impact scale, MFIS; Short Form 36, SF36) and quantitative sensory testing (QST), examining pain thresholds (thermal-, mechanical- and pressure pain). Assessments took place at study baseline and after the last session. Also, effects on body perception were obtained by an unvalidated questionnaire before and after each session (Questionnaire A and B, Q A&B). Data was analysed using linear mixed models.
The final results are currently pending.
Information on the availability of individual participant data
No
Institution does not provide accessible structures for data sharing, yet.
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
PD Athina Papadopoulou
+41 (0)61 265 2525
athina.papadopoulou@usb.ch
Contact for general information
(Data source: WHO)
Athina
Papadopoulou
Petersgraben 4
Universit?tsspital Basel Neurologie
+41 61 328 57 04
athina.papadopoulou@usb.ch
Contact for scientific information
(Data source: WHO)
Athina
Papadopoulou
Petersgraben 4
Universit?tsspital Basel Neurologie
+41 61 328 57 04
athina.papadopoulou@usb.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
03.03.2021
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2021-00067
Secondary ID (Data source: WHO)
SNCTP000004292
U1111-1264-9166
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