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Music Therapy and Bio-psychological Effect Among Chronic Psychiatric Inpatients of a Community Teaching Hospital

Primary Purpose

Chronic Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Music therapy
Biosignal analysis
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Psychosis focused on measuring music therapy, chronic psychosis, negative symptoms, occupational therapy, biosignal analysis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Change of negative symptoms of inpatients with psychotic disorders
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Change of negative symptoms of inpatients with psychotic disorders
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Change of quality of life
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 quality of life
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
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
Change of social and interactive skills
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)

Secondary Outcome Measures

Change of facial expression by action landmarks
To evaluate emotion (e.g. anger, fear, disgust, contempt, sadness, and surprise) via facial motion by iMotions device
Heart Rate Variability in Psychiatric Disorders analysis
Measure Heartbeat variability after intervention activities by "Dailycare" CheckMyHeart
Total sleeping time
Recorded by Fitbit health watch
Sleep schedule
Recorded by Fitbit health watch, meaning the hours patients are asleep
Sleep pattern
Recorded by Fitbit health watch, meaning the distribution of sleep stages (light sleep, deep sleep and rapid eye movement sleep).
Motion analysis
Analysis of the electromyography (EMG) of cases recorded by DELYSYS, EMG potentials range between less than 50 μV and up to 30 mV.

Full Information

First Posted
January 5, 2020
Last Updated
February 6, 2020
Sponsor
National Taiwan University Hospital
Collaborators
National Tsing Hua University
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1. Study Identification

Unique Protocol Identification Number
NCT04254965
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Tsing Hua University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Psychosis
Keywords
music therapy, chronic psychosis, negative symptoms, occupational therapy, biosignal analysis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 3
Arm Type
Sham Comparator
Arm Description
Participants in the control group receive their regular occupational therapy during the experimental period.
Intervention Type
Other
Intervention Name(s)
Music therapy
Intervention Description
Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.
Intervention Type
Device
Intervention Name(s)
Biosignal analysis
Other Intervention Name(s)
iMotions, GSR-Shimmer Module, Dailycare, Fitbit, DELYSYS TrignoTM Flex
Intervention Description
Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.
Primary Outcome Measure Information:
Title
Change of negative symptoms of inpatients with psychotic disorders
Description
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Time Frame
Before and immediately after finishing the music therapy
Title
Change of negative symptoms of inpatients with psychotic disorders
Description
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Time Frame
Before and 2 months after finishing the music therapy
Title
Change of quality of life
Description
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).
Time Frame
Before and immediately after finishing the music therapy
Title
Change of quality of life
Description
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).
Time Frame
Before and 2 months after finishing the music therapy
Title
Change of social and interactive skills
Description
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
Time Frame
Before and immediately after finishing the music therapy
Title
Change of social and interactive skills
Description
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
Time Frame
Before and 2 months after finishing the music therapy
Secondary Outcome Measure Information:
Title
Change of facial expression by action landmarks
Description
To evaluate emotion (e.g. anger, fear, disgust, contempt, sadness, and surprise) via facial motion by iMotions device
Time Frame
Two months
Title
Heart Rate Variability in Psychiatric Disorders analysis
Description
Measure Heartbeat variability after intervention activities by "Dailycare" CheckMyHeart
Time Frame
Two months
Title
Total sleeping time
Description
Recorded by Fitbit health watch
Time Frame
Two months
Title
Sleep schedule
Description
Recorded by Fitbit health watch, meaning the hours patients are asleep
Time Frame
Two months
Title
Sleep pattern
Description
Recorded by Fitbit health watch, meaning the distribution of sleep stages (light sleep, deep sleep and rapid eye movement sleep).
Time Frame
Two months
Title
Motion analysis
Description
Analysis of the electromyography (EMG) of cases recorded by DELYSYS, EMG potentials range between less than 50 μV and up to 30 mV.
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haifan Hsu
Phone
0980230620
Email
C10499@chut.ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Che Chen, MDMPH
Organizational Affiliation
National Taiwan University Hospital Chu-Tung Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Hsinchu
State/Province
Hsinchu County
ZIP/Postal Code
31064
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Che Chen, MDMPH
Phone
03-5943248
Email
hugocc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Music Therapy and Bio-psychological Effect Among Chronic Psychiatric Inpatients of a Community Teaching Hospital

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