Protocol summary

Summary
The aim of this study was to determine the effect of traditional music therapy on mental status of schizophrenic hospitalized patients.This study was a clinical trial, single center, with random allocation. The patients were allocated randomly in the study groups according to encoded sheets. The population of the study was the eligible chronic schizophrenic patients hospitalized in Sina Hospital in Jooneghan. Inclusion criteria was diagnosis of chronic schizophrenia. The patients with mental retardation or change in the treatment regimen during the study were excluded. Sixty patients were randomly allocated in traditional music therapy or control (routine treatment) groups (30 in each group). The intervention was conducted for 2 months. The positive and negative symptoms of the patients were evaluated at the beginning and the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412282085N14
Registration date: 2015-01-06, 1393/10/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-06, 1393/10/16
Registrant information
Name
Neda Parvin
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5652
Email address
nedali285@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of traditional music therapy on mental status of schizophrenic patients hospitalized in Sina Hospital Jooneghan
Public title
Effect of traditional music therapy on mental status of schizophrenic patients hospitalized in Sina Hospital Jooneghan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Physical ability; the diagnosis of chronic schizophrenia; aged between 18 and 70 years Exclusion criteria:Mental retardation; change in the treatment regimen during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Postal code
Approval date
2012-10-11, 1391/07/20
Ethics committee reference number
91-7-20

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20.5
ICD-10 code description
Residual schizophrenia

Primary outcomes

1

Description
Positive and negative symptoms
Timepoint
At the beginning and the end of the study
Method of measurement
Positive and negative symptoms questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Music therapy group: The patients in this group participated in group traditional music therapy sessions, 5 sessions each week for two months in addition to routine treatment.
Category
Treatment - Other

2

Description
Control group: The patients in this group received routine treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
ُSina Hospital in Jooneghan
Full name of responsible person
Neda Parvin
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences, Shahrekord
Full name of responsible person
Dr Mahmood Mobasheri
Street address
Shahrekord University of Medical Sciences, Kashani Street, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical Sciences, Shahrekord
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 383335652
Fax
Email
np285@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
np285@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Neda Parvin
Position
Lecturer, faculty member
Other areas of specialty/work
Street address
Rahmatiee, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
np285@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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