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

February 6, 2020 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Hsinchu County
      • Hsinchu, Hsinchu County, Taiwan, 31064
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
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.
Other: Music therapy
Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.
Device: Biosignal analysis
Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.
Other Names:
  • Fitbit
  • iMotions
  • GSR-Shimmer Module
  • Dailycare
  • DELYSYS TrignoTM Flex
ACTIVE_COMPARATOR: Group 2
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.
Other: Music therapy
Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.
Device: Biosignal analysis
Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.
Other Names:
  • Fitbit
  • iMotions
  • GSR-Shimmer Module
  • Dailycare
  • DELYSYS TrignoTM Flex
SHAM_COMPARATOR: Group 3
Participants in the control group receive their regular occupational therapy during the experimental period.
Device: Biosignal analysis
Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.
Other Names:
  • Fitbit
  • iMotions
  • GSR-Shimmer Module
  • Dailycare
  • DELYSYS TrignoTM Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of negative symptoms of inpatients with psychotic disorders
Time Frame: Before and immediately after finishing the music therapy
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Before and immediately after finishing the music therapy
Change of negative symptoms of inpatients with psychotic disorders
Time Frame: Before and 2 months after finishing the music therapy
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Before and 2 months after finishing the music therapy
Change of quality of life
Time Frame: 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).
Before and immediately after finishing the music therapy
Change of quality of life
Time Frame: 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).
Before and 2 months after finishing the music therapy
Change of social and interactive skills
Time Frame: Before and immediately after finishing the music therapy
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
Before and immediately after finishing the music therapy
Change of social and interactive skills
Time Frame: Before and 2 months after finishing the music therapy
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
Before and 2 months after finishing the music therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Tsing Hua University

Investigators

  • Principal Investigator: Cheng-Che Chen, MDMPH, National Taiwan University Hospital Chu-Tung Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 5, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201908035RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Psychosis

Clinical Trials on Music therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe