The effect of music therapy on the severity of positive and negative symptoms and function of patients with chronic schizophrenia
Design
Clinical Trial, No control group, single- blind study , consisted of 43 patients who underwent the intervention for 6 months
Settings and conduct
In the present study, 43 patients with schizophrenia will be selected from the patients of Parham Kashan Psychiatric Care Center. They will undergo music therapy sessions. Patients and Clinical caregiver are unaware of method of intervention and one of the colleagues plays the music and does the pre-test and post-test. They do not have a control group and all are subject to intervention. In addition, patients receive their medication during this period as usual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Chronic schizophrenia patients with no previous music therapy experience, Patients with a history of 1 to 2 years of residence in the center, Patients who have not received any new treatment in the past 6 months
Exclusion criteria: Patients with hearing impairment, Patients with vision impairment, Patients with movement disturbance, Patients with mental retardation
Intervention groups
The intervention group includes 43 patients with schizophrenia. There is no control group and all patients are in the intervention group.The intervention group undergoes music therapy sessions, the type of music is pop,which is played 3 times a week and 45 minutes in each session for six months.
Main outcome variables
Score of Global Assessment of Functioning(GAF), Score of Brief Psychiatric Rating Scale (BPRS) , Score of Positive and Negative Symptom Scale(PANSS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046532N1
Registration date:2022-08-11, 1401/05/20
Registration timing:retrospective
Last update:2022-08-11, 1401/05/20
Update count:0
Registration date
2022-08-11, 1401/05/20
Registrant information
Name
Mohamad Latifi Meybodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9111
Email address
latifi-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
2020-04-18, 1399/01/30
Actual recruitment end date
2020-10-21, 1399/07/30
Trial completion date
2020-10-21, 1399/07/30
Scientific title
The effect of music therapy on the severity of positive and negative symptoms and function of patients with chronic schizophrenia
Public title
Effect of music on patients with schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic schizophrenia patients with no previous music therapy experience
Patients with a history of 1 to 2 years of residence in the center
Patients who have not received any new treatment in the past 6 months
Exclusion criteria:
Patients with hearing impairment
Patients with vision impairment
Patients with movement disturbance
Patients with mental retardation
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
43
Actual sample size reached:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in this study know they are participating in a study But they do not know which symptoms are to be examined or which symptoms are the purpose of music therapy. Also, the clinical caregivers working in this center are unaware of the manner and type of intervention. One of the project partners plays music for the patients in each session and examines the severity of their symptoms before and after the intervention.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotb e Ravandi Blvd, Kashan Town
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2020-04-15, 1399/01/27
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.001
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Score of Global assessment of functioning ( GAF)
Timepoint
The variables are measured at the beginning of the intervention and 6 months after beginning of music therapy.
Method of measurement
Global assessment of functioning ( GAF)
2
Description
Score of Brief Psychiatric Rating Scale (BPRS)
Timepoint
The variables are measured at the beginning of the intervention and 6 months after beginning of music therapy.
Method of measurement
Brief Psychiatric Rating Scale (BPRS)
3
Description
ُScore of Positive and Negative Symptom Scale (PANSS)
Timepoint
The variables are measured at the beginning of the intervention and 6 months after beginning of music therapy.
Method of measurement
Positive and Negative Symptom Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group includes 43 patients with schizophrenia There is no control group and all patients are in the intervention group.The intervention group undergoes music therapy sessions, the type of music is pop, which is played 3 times a week and 45 minutes in each session for six months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Parham Psychiatric Patient Care Center
Full name of responsible person
Dr Afshin Ahmadvand
Street address
2 km Noshadabad Ave ,Shohada Square, Vali Asr Square, Kashan.
City
Kashan
Province
Isfehan
Postal code
8715949152
Phone
+98 31 5558 5020
Email
parham_kashan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Kashan University of Medical Sciences,Ghotb ravandi Boulevard.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5544 3020
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohamad Latifi Meybodi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Beheshi Hospital,Ghotb ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 9111
Email
latifi.meybodi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohamad Latifi Meybodi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Beheshti Hospital, Ghotbravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 9111
Email
latifi.meybodi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohamad Latifi Meybodi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Beheshti Hospital,Ghotb ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 9111
Email
latifi.meybodi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Everyone has access to data and documentation
Under which criteria data/document could be used
Use of data is permitted for comparative and systematic studies
From where data/document is obtainable
To receive information, send your request to Kashan University of Medical Sciences at kaums.ac.ir
What processes are involved for a request to access data/document
To receive information, first submit a request to Kashan University of Medical Sciences. After confirmation, the applicant can receive the documents via email to latifi.meybodi@gmail.com from Dr. Mohammad Latifi Meybodi