The Effectiveness of Music Therapy with Aerobic exercise in Control of Positive and Negative Syndromes and Improving Sleep Quality in Patients with Schizophrenia
The aim of this study is finding the effects of music therapy, aerobic exercise and music therapy combine with aerobic exercise in control of positive and negative symptoms and improving sleep quality of Patients with Schizophrenia.
Design
Clinical trial with 3 experimental group (n=45); (music therapy (n=15); aerobic exercise (n=15); music therapy with aerobic exercise (n=15) and one control group (n=15), parallel groups, random assignment
Settings and conduct
The study will be performed in 8 educational sessions for three experimental groups at Darol shafa rehabilitation center in Ardabil without blinding
Participants/Inclusion and exclusion criteria
A diagnosis of schizophrenia by a psychiatrist based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
aged 18–65 years; changes in medication during the intervention; medical contraindication for physical activity
Intervention groups
Experimental group 1: 8 1-hour sessions of music therapy for 2 months; Experimental group 2: 8 1-hour sessions of aerobic exercise for 2 months; Experimental group 3: 8 1-hour sessions of music therapy with aerobic exercise for 2 months; control group: without training
Main outcome variables
Positive and negative symptoms ; quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171212037852N2
Registration date:2019-06-08, 1398/03/18
Registration timing:registered_while_recruiting
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Mahdieh Jafari
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5000
Email address
m.jafari@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-27, 1398/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Music Therapy with Aerobic exercise in Control of Positive and Negative Syndromes and Improving Sleep Quality in Patients with Schizophrenia
Public title
The Effectiveness of Music Therapy with Aerobic exercise in improvement of symptoms in Patients with Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
a diagnosis of schizophrenia by a psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
age18–65 years
Exclusion criteria:
changes in medication during the intervention
medical contraindication for physical activity
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The member of sample assigned in the experimental and control group by lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Scienses
Street address
Daneshgah Ave.
City
Ardabil
Province
Ardabil
Postal code
5451917961
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.ARUMS.REC.1397.291
Health conditions studied
1
Description of health condition studied
Schizophrenic patients
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
positive and negative symptoms
Timepoint
Before the intervention and 1 week after the intervention
Method of measurement
Positive and Negative syndrome scale
Secondary outcomes
1
Description
Quality of sleep
Timepoint
Before the intervention and 1 week after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Intervention group: Music therapy. Before performing music therapy, the pre-test will be perform. Music therapy will hold in 8 sessions for four weeks (twice a week). Each session last 60 min. This intervention comprise of passive music interventions including music listening. The music use in this study include eight light music that play with an mp3 player attach to a speaker. During the intervention, the participants should not draw or image to the music, but they will allow to talk about that after finishing the session. Patients will ask to concentrate on the music to become relaxed and lie in a bed or chair in comfortable position during the music therapy sessions. After performing music therapy, the post-test will be perform.
Category
Rehabilitation
2
Description
Intervention group: Aerobic exercise. Before performing the aerobic exercises, the pre-test will be perform. The aerobic exercise program consisted of eight exercise sessions over the course of four weeks. Each session of the aerobic exercise involve stretching the large muscle groups as a warm-up (10 min), performing the aerobic exercise during the main phase (40 min), and stretching the center-based muscle during a cool-down stage (10 min). After performing aerobic exercises, the post-test will be perform.
Category
Rehabilitation
3
Description
Intervention group: Music therapy with aerobic exercise. In this group, after performing the pre-test the patients will be receive music therapy and aerobic exercise, according to the protocol of two other intervention groups that explained. In this method, aerobic exercise will be perform in the morning and music therapy will be perform in the evening. At the end of the interventions the post-test will be perform.
Category
Rehabilitation
4
Description
Control group: without training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Darolshafa rehabilitation center
Full name of responsible person
Milad Bazazorde
Street address
Kosar Town, Darolshafa rehabilitation center
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 41 4433 3120
Email
Milad_bazazorde@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ْThe University of Mohaqeq Ardabili
Full name of responsible person
Ali Akbar Atadokht
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, university street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5698725761
Phone
+98 45 3551 2081
Email
ak_atadokht@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ْThe University of Mohaqeq Ardabili
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
The University of Mohaghegh Ardabili
Full name of responsible person
Milad Bazazorde
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 45 3551 2081
Email
milad_bazazorde@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Milad Bazazorde
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 45 3551 2081
Email
milad_bazazorde@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
Full name of responsible person
Milad Bazazorde
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Education & Psychology, University of Mohaqeq Ardabili, University street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5451917961
Phone
+98 45 3551 2081
Email
milad_bazazorde@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available