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临床试验/NCT04254965
NCT04254965Unknown不适用

Music Therapy Intervention and Bio-psychological Effects Evaluation Among Chronic Psychiatric Inpatients in Rehabilitation Wards of a Community Teaching Hospital

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Change of social and interactive skills

研究概览

简要总结

Negative symptoms are an important factor in preventing patients from returning to the community, we aim to assess the effect of music therapy on negative symptoms through this study. Participants of integrated music therapy will receive instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. Other participants will receive passive music listening or regular occupational therapy during the experimental period. Psychiatric symptoms, quality of life, social and interactive skills, and the differences in the physiological signals produced by skin, muscles, and heart will be measured before, after, and two months after the music therapy.

详细描述

Music therapy is gradually being used in the field of psychiatry, such as depression, anxiety, and development disorders in children. However, music therapy still lacks systematic research on chronic mental illness. Since negative symptoms are an important factor in preventing patients from returning to the community, we aim to assess the effect of music therapy on negative symptoms through this study. Additionally, Taiwan as many Asian countries have not yet established a certification system for music therapy. This study cooperates with licensed therapists abroad in the hope of promoting the systematic development of local music therapy in the future.

Participants of integrated music therapy (Group 1, integration of active and passive music therapy) includes instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. The four stages of activities are warm-up, main activities, secondary activities, and the ending section. The participants of the music listening group (Group 2, background music listening), music selection based on the musical preference and background of subjects, for relax or boost the spirit of the subjects. Participants in the control group (Group 3) receive their regular occupational therapy during the experimental period. We plan to recruit 100 people in the wards: 40/20/40 (Group 1/2/3) under random assignment.

To evaluate the effects of three groups, we measure their psychiatric symptoms, quality of life, social and interactive skills, and the differences in the physiological signals produced by skin, muscles, and heart assisted by a medical engineering scholar before, after, and two months after the music therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Chronic patient in rehabilitation ward without compulsory hospitalization.
  • •Patients with mental, behavioral and neurodevelopmental disorders, including schizophrenia, schizotypal personality disorders, delusional disorders, affective disorders, and organic mental disorders.

排除标准

  • •Patients with hearing impairments.
  • •Patients with no capacity to make juridical acts.

研究组 & 干预措施

Group 1

Experimental

Participants of integrated music therapy (integration of active and passive music therapy) includes instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. The four stages of activities are warm-up, main activities, secondary activities, and the ending section.

干预措施: Music therapy (Other)

Group 1

Experimental

Participants of integrated music therapy (integration of active and passive music therapy) includes instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. The four stages of activities are warm-up, main activities, secondary activities, and the ending section.

干预措施: Biosignal analysis (Device)

Group 2

Active Comparator

Participants of the music listening group will receive background music listening, music selection based on the musical preference and background of subjects, for relax or boost the spirit of the subjects.

干预措施: Music therapy (Other)

Group 2

Active Comparator

Participants of the music listening group will receive background music listening, music selection based on the musical preference and background of subjects, for relax or boost the spirit of the subjects.

干预措施: Biosignal analysis (Device)

Group 3

Sham Comparator

Participants in the control group receive their regular occupational therapy during the experimental period.

干预措施: Biosignal analysis (Device)

结局指标

主要结局

Change of social and interactive skills

时间窗: Before and 2 months after finishing the music therapy

Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)

Change of negative symptoms of inpatients with psychotic disorders

时间窗: Before and 2 months after finishing the music therapy

Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)

Change of quality of life

时间窗: Before and 2 months after finishing the music therapy

Using the World Health Organization Quality of Life-BREF questionnaire (it is a compress name, Traditional Chinese version). The WHOQOL-BREF was derived from data collected using the WHOQOL-100. It produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health. Potential scores for all domain scores range from 4(worse) to 20(better).

Change of negative symptoms of inpatients with psychotic disorders

时间窗: Before and immediately after finishing the music therapy

Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)

Change of quality of life

时间窗: Before and immediately after finishing the music therapy

Using the World Health Organization Quality of Life-BREF questionnaire (it is a compress name, Traditional Chinese version). The WHOQOL-BREF was derived from data collected using the WHOQOL-100. It produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health. Potential scores for all domain scores range from 4(worse) to 20(better).

Change of social and interactive skills

时间窗: Before and immediately after finishing the music therapy

Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)

次要结局

  • Change of facial expression by action landmarks(Two months)
  • Heart Rate Variability in Psychiatric Disorders analysis(Two months)
  • Sleep schedule(Two months)
  • Total sleeping time(Two months)
  • Motion analysis(Two months)
  • Sleep pattern(Two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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