Clinical trial NCT04254965: Music Therapy and Bio-psychological Effect Among Chronic Psychiatric Inpatients of a Community Teaching Hospital
Official title: Music Therapy Intervention and Bio-psychological Effects Evaluation Among Chronic Psychiatric Inpatients in Rehabilitation Wards of a Community Teaching Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Psychosis
Keywords: music therapy
chronic psychosis
negative symptoms
occupational therapy
biosignal analysis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Tsing Hua University
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria

* 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.

Exclusion criteria

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

Primary outcomes:
measure: Change of negative symptoms of inpatients with psychotic disorders
timeFrame: Before and immediately after finishing the music therapy
measure: Change of negative symptoms of inpatients with psychotic disorders
timeFrame: Before and 2 months after finishing the music therapy
measure: Change of quality of life
timeFrame: Before and immediately after finishing the music therapy
measure: Change of quality of life
timeFrame: Before and 2 months after finishing the music therapy
measure: Change of social and interactive skills
timeFrame: Before and immediately after finishing the music therapy
measure: Change of social and interactive skills
timeFrame: Before and 2 months after finishing the music therapy
Secondary outcomes:
measure: Change of facial expression by action landmarks
timeFrame: Two months
measure: Heart Rate Variability in Psychiatric Disorders analysis
timeFrame: Two months
measure: Total sleeping time
timeFrame: Two months
measure: Sleep schedule
timeFrame: Two months
measure: Sleep pattern
timeFrame: Two months
measure: Motion analysis
timeFrame: Two months
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital
state: Hsinchu County
Study officials:
affiliation: National Taiwan University Hospital Chu-Tung Branch
name: Cheng-Che Chen, MDMPH
role: PRINCIPAL_INVESTIGATOR
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