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 treatments approaches can improve well-being and maintain an optimal quality of life (QoL) of those living with dementia. Other outcomes associated to QoL, such as pain, discomfort and sleep disruption are relevant outcomes in trials as well. Music therapy is a non-pharmacological treatment that can reduce NPS and improve wellbeing, and its associated symptoms in dementia.

Methods: The research is conducted at eight facilities of one nursing home organization in the Netherlands. The participants in the intervention group receive 30 minutes 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 receive 30 minutes 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, assesses directly observed wellbeing (primary outcome) and pain before and after the sessions. Nurses assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS assessed with validated scales. The sleepy duration will be indirectly assessed by a wrist device called MotionWatch. Information about psychotropic drug use is 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 wellbeing 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.

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.

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Journal: Clinical Trial Protocol

Keywords: behavioural symptoms, Dementia, music therapy, neuropsychiatric symptoms, nursing homes, psychosocial intervention, Quality of life, randomized controlled trial, Sleep,

Applications: Sleep,

CamNtech Reference: M22069

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