The effects of individual music therapy in nursing home residents with dementia to improve general well-being: study protocol of a randomized controlled trial.

BACKGROUND: Dementia is often associated with Neuropsychiatric Symptoms (NPS) such as agitation, depression, hallucinations, anxiety, that can cause distress for the resident with dementia in long-term care settings and can impose emotional burden on the environment. NPS are often treated with psychotropic drugs, which, however, frequently cause side effects. Alternatively, non-pharmacological interventions can improve well-being and maintain an optimal quality of life (QoL) of those living with dementia. Other QoL related outcomes, such as pain, discomfort and sleep disruption are relevant outcomes in music trials as well. Music therapy is a non-pharmacological intervention that can reduce NPS and improve well-being, and its associated symptoms in dementia. METHODS: The research will be conducted at eight nursing home facilities of a health care organization in the Netherlands. A sample size of 30 in each group (experimental and control group) is required, totalling 60 residents increased to 80 when considering expected drop out to follow up. The participants in the intervention group receive 30 min of individual music therapy (MT) in their own room by a music therapist twice a week for 12 weeks. The participants in the control group will receive 30 min of individual attention in their own room by a volunteer twice a week for 12 weeks. Assessments will be done at baseline, 6 weeks and 12 weeks. An independent observer, blinded for the intervention or control condition, will assess directly observed well-being (primary outcome) and pain (secondary outcome) before and after the sessions. Nurses will assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS, both assessed with validated scales. The sleep duration will be indirectly assessed by a wrist device called MotionWatch. Information about psychotropic drug use will be derived from electronic medical chart review. DISCUSSION: The main purpose of this study is to assess the effects of individual music therapy on directly observed well-being controlled for individual attention in nursing home residents with dementia with NPS. The outcomes refer to both short-term and long-term effects consistent with therapeutic goals of care for a longer term. We hope to overcome limitations of previous study designs such as not blinded designs and music facilitators that were not only music therapists but also occupational therapists and nurses. This study should lead to more focused recommendations for practice and further research into non-pharmacological interventions in dementia such as music therapy. TRIAL REGISTRATION: The trial is registered at the International Clinical Trials Registry Platform (ICTRP) search portal in the Netherlands Trial Registration number NL7708, registration date 04-05-2019.

Effects of a music therapy and music listening intervention for nursing home residents with dementia: a randomized controlled trial.

Introduction: The aim of the present study was to evaluate the effects of an individual music therapy intervention and an individual music listening intervention on neuropsychiatric symptoms and quality of life in people with dementia living in a nursing home and on professional caregiver's burden to be able to make statements about their specific value of application in clinical practice. Methods: A multicenter single blind randomized controlled trial with three groups was performed: an individual music therapy intervention (IMTI) group (n = 49), an individual music listening intervention (IMLI) group (n = 56) and a control group (n = 53) receiving usual care. The interventions were given during three weeks, three times a week on non-consecutive days during 30-45 minutes for in total nine sessions. The endpoint of the study is the difference from baseline to interim (1,5 week), post-intervention (3 weeks) and follow-up (6 weeks) in reported scores of problem behaviour (NPI-NH) and quality of life (Qualidem) in people with dementia and occupational disruptiveness (NPI-NH) in care professionals. Results: In total 158 people with dementia were randomized to one of the two intervention groups or the control group. Multilevel analyses demonstrated that hyperactive behaviour assessed by the NPI-NH was significantly more reduced for the IMLI group at follow up and that restless behaviour assessed by the Qualidem was significantly more reduced for the IMTI group at post and follow-up measurement compared to the control group. No significant effects between groups were found in other NPI-NH clusters or Qualidem subscales. Conclusion: In conclusion, because we found no convincing evidence that the IMTI or IMLI is more effective than the other both interventions should be considered in clinical practice. For the future, we advise further research into the sustainability of the effects with alternative designs, like a single case experimental design.

The Effect of Music Therapy in Patients with Huntington's Disease: A Randomized Controlled Trial.

BACKGROUND: Music therapy may have beneficial effects on improving communication and expressive skills in patients with Huntington's disease (HD). Most studies are, however, small observational studies and methodologically limited. Therefore we conducted a multi-center randomized controlled trial. OBJECTIVE: To determine the efficacy of music therapy in comparison with recreational therapy in improving quality of life of patients with advanced Huntington's disease by means of improving communication. METHOD: Sixty-three HD-patients with a Total Functional Capacity (TFC) score of ≤7, admitted to four long-term care facilities in The Netherlands, were randomized to receive either group music therapy or group recreational therapy in 16 weekly sessions. They were assessed at baseline, after 8, 16 and 28 weeks using the Behaviour Observation Scale for Huntington (BOSH) and the Problem Behaviour Assessment-short version (PBA-s). A linear mixed model with repeated measures was used to compare the scores between the two groups. RESULTS: Group music therapy offered once weekly for 16 weeks to patients with Huntington's disease had no additional beneficial effect on communication or behavior compared to group recreational therapy. CONCLUSION: This was the first study to assess the effect of group music therapy on HD patients in the advanced stages of the disease. The beneficial effects of music therapy, recorded in many, mainly qualitative case reports and studies, could not be confirmed with the design (i.e. group therapy vs individual therapy) and outcome measures that have been used in the present study. A comprehensive process-evaluation alongside the present effect evaluation is therefore performed.