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

NCT04254965 | Unknown DMC FDA Device

• 1 other identifier: 201908035RINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Psychosis

Keywords

music therapy; chronic psychosis; negative symptoms; occupational therapy; biosignal analysis

Outcome Measures

Primary Outcomes (6)

• Change of negative symptoms of inpatients with psychotic disorders

  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

  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

  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

  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

  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

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

  Before and 2 months after finishing the music therapy

Secondary Outcomes (6)

• Change of facial expression by action landmarks

  Two months

• Heart Rate Variability in Psychiatric Disorders analysis

  Two months

• Total sleeping time

  Two months

• Sleep schedule

  Two months

• Sleep pattern

  Two months

Study Arms (3)

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.

Other: Music therapy; Device: Biosignal analysis

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.

Other: Music therapy; Device: Biosignal analysis

Group 3

SHAM COMPARATOR

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

Device: Biosignal analysis

Interventions

Music therapy OTHER

Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.

Group 1; Group 2

Biosignal analysis DEVICE

Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.

Also known as: iMotions, GSR-Shimmer Module, Dailycare, Fitbit, DELYSYS TrignoTM Flex

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Tsing Hua University: collaborator

Study Sites (1)

National Taiwan University Hospital

Hsinchu, Hsinchu County, 31064, Taiwan

Location

Related Publications (14)

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  PMID: 3518914 BACKGROUND

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  PMID: 14984391 BACKGROUND

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  PMID: 16897904 BACKGROUND

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  PMID: 26812906 BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Cheng-Che Chen, MDMPH

  National Taiwan University Hospital Chu-Tung Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haifan Hsu

CONTACT

0980230620; C10499@chut.ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: February 5, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)