Effects of Receptive Music Therapy with a Monochord in multiple sclerosis (MUTIMS) – a randomized controlled study - MUTIMS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.