Individualised music playlist based on the iso-principle for de-escalating agitation in older people with dementia: protocol for a RCT

Aim: To evaluate the efficacy of an individualised music playlist composed of preferred music genres sequenced using the Iso-Principle (InMP) for immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU). Design: A multi-centre, three-arm randomised controlled trial. Methods: Residential home residents with dementia and significant agitation would be randomly allocated to InMP, PM, or TAU groups. All participants would receive usual de-escalation techniques when agitated. The InMP group would additionally listen to music sequenced by the Iso-Principle for 30 min when agitation begins, while the PM group would listen to randomly sequenced preferred music. The primary outcome is agitation level, assessed every 5 min for an hour after each agitation onset. Scores from each 5-min interval would be calculated to give an area-under-curve score to summarise the agitation level of that episode and compared across groups. Secondary outcomes include agitation frequency, behavioural and psychological symptoms severity and carer distress, measured at baseline and Week 6 using CMAI and NPI-Q and analysed using GEE. Conventional content analysis of semi-structured interviews with care staff would be used for implementation factors. Implications for the Profession and/or Patient Care: This study would employ a rigorous approach to evaluate the effects of the intervention. The findings would inform evidence-based strategies for nursing practice to promptly de-escalate agitation in dementia, potentially reducing reliance on medications and physical restraints, improving care quality, and alleviating carer burden. Impact: Agitation negatively impacts both residents and carers. While music interventions can reduce agitation frequency, their effectiveness for immediate de-escalation and impact on carer distress remain unknown. This study addresses the knowledge gap and aims to provide practical solutions for a prevalent clinical problem. Patient or Public Contribution: Service providers commented on intervention design and outcome measurement approaches, ensuring the research addresses the needs of individuals with dementia and the protocol is practical for implementation. Trial Registration: ClinicalTrials.gov: NCT06104436.