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

Chronic Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04254965
• Other study ID #: 201908035RINC
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: National Taiwan University Hospital
• Contact: Haifan Hsu
• Phone: 0980230620
• Email: C10499[@]chut.ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Hsinchu	Hsinchu County

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Tsing Hua University

Country where clinical trial is conducted

Taiwan, 

References & Publications (14)

Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x. — View Citation

Buccheri R, Trygstad L, Dowling G, Hopkins R, White K, Griffin JJ, Henderson S, Suciu L, Hippe S, Kaas MJ, Covert C, Hebert P. Long-term effects of teaching behavioral strategies for managing persistent auditory hallucinations in schizophrenia. J Psychosoc Nurs Ment Health Serv. 2004 Jan;42(1):18-27. — View Citation

Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. — View Citation

Cook JD. Music as an intervention in the oncology setting. Cancer Nurs. 1986 Feb;9(1):23-8. — View Citation

Gold C, Rolvsjord R, Aaro LE, Aarre T, Tjemsland L, Stige B. Resource-oriented music therapy for psychiatric patients with low therapy motivation: protocol for a randomised controlled trial [NCT00137189]. BMC Psychiatry. 2005 Oct 31;5:39. — View Citation

Hars M, Herrmann FR, Gold G, Rizzoli R, Trombetti A. Effect of music-based multitask training on cognition and mood in older adults. Age Ageing. 2014 Mar;43(2):196-200. doi: 10.1093/ageing/aft163. Epub 2013 Nov 7. — View Citation

Hayashi N, Tanabe Y, Nakagawa S, Noguchi M, Iwata C, Koubuchi Y, Watanabe M, Okui M, Takagi K, Sugita K, Horiuchi K, Sasaki A, Koike I. Effects of group musical therapy on inpatients with chronic psychoses: a controlled study. Psychiatry Clin Neurosci. 2002 Apr;56(2):187-93. — View Citation

Morgan KA, Harris AW, Luscombe G, Tran Y, Herkes G, Bartrop RW. The effect of music on brain wave functioning during an acute psychotic episode: a pilot study. Psychiatry Res. 2010 Jul 30;178(2):446-8. doi: 10.1016/j.psychres.2010.04.020. Epub 2010 May 14. — View Citation

Peng SM, Koo M, Kuo JC. Effect of group music activity as an adjunctive therapy on psychotic symptoms in patients with acute schizophrenia. Arch Psychiatr Nurs. 2010 Dec;24(6):429-34. doi: 10.1016/j.apnu.2010.04.001. Epub 2010 May 21. — View Citation

Silverman MJ. Psychiatric patients' perception of music therapy and other psychoeducational programming. J Music Ther. 2006 Summer;43(2):111-22. — View Citation

Talwar N, Crawford MJ, Maratos A, Nur U, McDermott O, Procter S. Music therapy for in-patients with schizophrenia: exploratory randomised controlled trial. Br J Psychiatry. 2006 Nov;189:405-9. — View Citation

Tseng PT, Chen YW, Lin PY, Tu KY, Wang HY, Cheng YS, Chang YC, Chang CH, Chung W, Wu CK. Significant treatment effect of adjunct music therapy to standard treatment on the positive, negative, and mood symptoms of schizophrenic patients: a meta-analysis. BMC Psychiatry. 2016 Jan 26;16:16. doi: 10.1186/s12888-016-0718-8. Erratum in: BMC Psychiatry. 2016;16:150. — View Citation

Ulrich G, Houtmans T, Gold C. The additional therapeutic effect of group music therapy for schizophrenic patients: a randomized study. Acta Psychiatr Scand. 2007 Nov;116(5):362-70. — View Citation

Wiersma D, Jenner JA, Nienhuis FJ, van de Willige G. Hallucination focused integrative treatment improves quality of life in schizophrenia patients. Acta Psychiatr Scand. 2004 Mar;109(3):194-201. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	Two months
Secondary	Heart Rate Variability in Psychiatric Disorders analysis	Measure Heartbeat variability after intervention activities by "Dailycare" CheckMyHeart	Two months
Secondary	Total sleeping time	Recorded by Fitbit health watch	Two months
Secondary	Sleep schedule	Recorded by Fitbit health watch, meaning the hours patients are asleep	Two months
Secondary	Sleep pattern	Recorded by Fitbit health watch, meaning the distribution of sleep stages (light sleep, deep sleep and rapid eye movement sleep).	Two months
Secondary	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.	Two months