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临床试验/NCT04236557
NCT04236557已完成不适用

Individualized Music Playlist Based on ISO-Principle for De-escalating Agitation of People Living With Dementia: A Randomized Controlled Feasibility Study

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Attrition rate

研究概览

简要总结

Abstract:

Agitation is exhibited by almost every dementia patient during the course of illness, and that leads to detrimental consequences on both patients and caregivers. Listening to preferred music is found useful in reducing the agitation frequency of people with dementia. However, the music intervention is usually provided regularly and the music psychotherapy ISO-Principle is ignored in published studies. The ISO-Principle that commonly adopted in music therapy using live-music, suggests that characteristics of music being played (e.g. tempo, melody and lyrics) should match with the current state (e.g. manic/depressive) of the client, and gradually modify these characteristics to the desired state. This randomized feasibility trial aims to evaluate the feasibility of using individualized music playlist with the music genres sequenced according to the ISO-Principle, for de-escalating agitation of people with dementia, and provide preliminary evidence on efficacy.

Eighty-four nursing home residents with agitation will be randomly allocated into music listening or control groups. Acceptability, implementation and practicality, as well as efficacy (in terms of agitation intensity, stress and mood states before and after the de-escalating music intervention or control condition; and occurrence of agitation and other behavioural and psychological symptoms of dementia before and after the 6-week observation period).

Feasibility indicators will be reported descriptively. The efficacy of (1) music listening in de-escalating symptoms and (2) reducing occurrence frequency of symptoms after 6 weeks, will be analysed with Generalized Estimating Equation. If the findings are positive, the intervention have a great potential to be adopted as the gold standard of care in the nursing homes to solve a common yet detrimental clinical problem.

详细描述

  1. Aims and objectives:

This study is to evaluate the feasibility of the individualized music playlist based on ISO-Principle for de-escalating agitation of nursing home residents living with dementia.

Objectives are as below:

  1. To evaluate the feasibility of the intervention in terms of recruitment, retention, and acceptability.

  2. To examine the preliminary effects of the intervention on participants' agitation, stress and emotion as compared to control group.

  3. To evaluate suitability of outcome assessment instruments.

  4. Methods:

  5. Design:

  • A two arms randomized controlled feasibility trial.
  1. Participants and setting:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Nursing home residents with medical diagnosed of any type of dementia; presented with significant agitation in the past two weeks before recruitment;
  • expected to be present in the facility every Monday to Friday during the study period; and
  • Aged 60 or above;

排除标准

  • Nursing home residents who were admitted to the nursing home for less than 3 months;
  • participating in other studies or experimental therapies, or blinded treatments;
  • those with comorbid psychiatric illness such as depression, schizophrenia;
  • or those with uncorrectable hearing impairment.
  • Concurrent psychotropic medications over the study period is allowed but any change in the prescriptions will be monitore

结局指标

主要结局

Attrition rate

时间窗: The 6th week

The percentage of recruited participant dropped out from the project prematurely

Recruitment rate

时间窗: At baseline

The percentage of eligible participants who finally agreed to join the project

Satisfaction rate

时间窗: At the end of the 6th week

Satisfaction of the intervention rated by staff using self-developed rating scale

次要结局

  • Heart rate(Continuously during the 6-week study period)
  • Agitation frequency(Screening, Baseline, at the end of the project (i.e. the 6th week))
  • Behavioural and psychological symptoms of dementia frequency(Screening, Baseline, at the end of the project (i.e. the 6th week))
  • Agitation Intensity(During the 6-week study period, before and immediate after listening to the audio when agitated)
  • Mood States(During the 6-week study period, before and immediate after listening to the audio when agitated)
  • State of Arousal(During the 6-week study period, before and immediate after listening to the audio when agitated)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Daphne Cheung

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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