Effects of Receptive Music Therapy with a Monochord in multiple sclerosis (MUTIMS) – a randomized controlled study
Organizational Data
- DRKS-ID:
- DRKS00024549
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-03-15
- Last update in DRKS:
- 2024-04-16
- Registration type:
- Prospective
Acronym/abbreviation of the study
MUTIMS
URL of the study
No Entry
Brief summary in lay language
The study's main objective is to investigate whether receptive music therapy with the instrument "Monochord" can reduce anxiety in people with multiple sclerosis (MS). Further objectives are to investigate whether it reduces depression, stress perception, cognitive decline and pain perception, and if it increases quality of life. The treatment-monochord is a big wooden string instrument, which consists of a sounding body and a couch on top to lie on. The strings are clamped beneath the instrument While a patient is lying on the instrument, the music therapist plays the strings like a harp. The vibrations are transmitted onto the whole body and can lead to deep relaxation and the perception of vastness. Receptive music therapy can be a complementary treatment for MS. Study participants will lie on the treatment-monochord during aprroximately 15 minutes. Beforehand and afterwards they will have a short introductory and closing talk of 5 - 10 minutes with the music therapist. The intervention is no psychotherapy and cannot replace such. At study start participants will be randomly assigned to two groups. The interventional group will follow the program as described above. The comparison group will relax on the treatment-monochord for 10-15 minutes, without the music therapist playing the strings so that no music can be heard. Participants will have the introductory and closing talk as well. Directly before and after the music therapeutic sessions both groups will fill in a questionnaire about their well-being. In addition, patients participate in two study visits of about 2 hours time at the beginning and at the end of the study. Questionnaires regarding anxiety, depression, stress perception, fatigue and quality of life will be recorded. A short test regarding cognitive performance will be performed. Thresholds for perception of pain, warmth, cold, etc. will be measured with a specific device on the back of the hands. Eight weeks after study end one questionnaire has to be filled in again and can be sent to the study center. Study participants have to be diagnosed with relapsing or progressive MS and have to follow their treatment and care at the MS Center of the University Hospital of Basel - the only study site. Study start is planned for March 2021 and study end approximately one year later, the study lasting 16 weeks for each participant. The participants of the comparison group will receive vouchers for 6 music-therapy sessions after study end.
Brief summary in scientific language
The objective of this monocentric randomized controlled study in an ambulatory setting is to investigate the effects of receeptive music therapy with the instrument "Monochord" in people with multiple sclerosis (MS) on anxiety and further psychosocial factors: depression, stress perception, fatigue, quality of life, well-being, cognition and thresholds of pain perception. Receptive music theraapy, during which a person absorbs music without playing an instrument himself/herself, can lead to i.a. states of deep relaxation. The treatment-monochord is a big wooden string instrument, which consists of a sounding body with a couch on top to lie on. The strings are clamped beneath the instrument While a patient is lying on the treatment-monochord, the music therapist plays the strings like a harp. The vibrations are transmitted onto the whole body and can lead to deep relaxation. Receptive music therapy can be a complementary treatment for MS. Participants will be randomized 1:1 to an intervention an a control group. Study length is 16 weeks per participant. Study start is planned for March 2021, study end approximately one year later. The monocentric study is performed at the MS Center of the University Hospital Basel, Switzerland.
Health condition or problem studied
- Free text:
- Multiple sclerosis
- ICD10:
- G35.1
- ICD10:
- G35.2
- ICD10:
- G35.3
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- 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.
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsspital Basel Basel
Recruitment period and number of participants
- Planned study start date:
- 2021-03-28
- Actual study start date:
- 2021-05-05
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-09-07
- Target Sample Size:
- 60
- Final Sample Size:
- 57
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Universitätsspital Basel NeurologiePD Dr. med. Athina PapadopoulouPetersgraben 44031 BaselSwitzerland
- Telephone:
- +41 61 328 57 04
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unispital-basel.ch
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsspital Basel NeurologieJenni KuhlmannPetersgraben 44031 BaselSwitzerland
- Telephone:
- +41 61 328 67 91
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unispital-basel.ch
Contact for Public Queries
- Address:
- Universitätsspital Basel NeurologieAndrea ZimmerPetersgraben 44031 BaselSwitzerland
- Telephone:
- +41 61 556 53 35
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unispital-basel.ch
Principal Investigator
- Address:
- Universitätsspital Basel NeurologieJenni KuhlmannPetersgraben 44031 BaselSwitzerland
- Telephone:
- +41 61 328 67 91
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.unispital-basel.ch
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsspital BaselPetersgraben 44031 BaselSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission Nord-West-Schweiz [Ethikkommission Nord-West-Schweiz Hebelstrasse 53 CH-4056 Basel, Tel.: 0041 61 268 13 50, Email: eknz@bs.ch URL: www.eknz.ch]Hebelstrasse 534056 BaselSwitzerland
- Telephone:
- 0041 61 268 13 50
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.eknz.ch/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-01-15
- Ethics committee number:
- 2021-00067
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-03-03
Further identification numbers
- Other primary registry ID:
- SNCTP000004292 - Swiss National Clinical Trials Portal
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Institution does not provide accessible structures for data sharing, yet.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- Juli 2024
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- 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.