Protocol summary

Study aim
The Effect of Drama Therapy with Electra compulsive Therapy on the Social Skills of People with Schizophrenia
Design
The statistical population includes all patients with schizophrenia referring to Semnan medical centers based on incoming criteria. The sampling method will be available from the type of samples that will be assigned as a non-randomized assignment in two groups of testing and control.
Settings and conduct
The location of the study will be in the Kowsar Medical and Hospital Hospital of Semnan. Theater therapy is conducted in a 8-session program of 3 days a week for 60 minutes. And shock therapy sessions are performed in 6 sessions, 3 days a week.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include ages 30-50 years, people with schizophrenia disorder with negative symptoms and psychiatrist's diagnosis, ability to read and write, and exclusion criteria including other psychiatric disorders, poor person collaboration, presence of positive symptoms in a person, Mental disability, seizure, cardiovascular disease
Intervention groups
There are three therapeutic groups in this study. The experimental group received theatrical therapy with shock therapy, the control group receiving the shock therapy, the other control group receiving theatrical therapy.
Main outcome variables
Bar-an's Emotional Intelligence Questionnaire, Granovsky's Cognitive Therapy Settlement, World Health Organization's Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171219037954N3
Registration date: 2018-10-25, 1397/08/03
Registration timing: registered_while_recruiting

Last update: 2018-10-25, 1397/08/03
Update count: 0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
Minasadat Mirshoja
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
msj5831@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Drama Therapy with Electra compulsive Therapy on Social Skills in Schizophrenia
Public title
Drama Therapy with Electra compulsive Therapy on Social Skills in Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 30-50 years Negative symptoms Reading and writing ability
Exclusion criteria:
Other psychiatric disorders Poor person collaboration Positive symptoms Mental disability Seizure Cardiovascular disease
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the Semnan University of Medical science
Street address
15 km Damghan Road- Semnan University of Medical Sciences- Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-08-23, 1397/06/01
Ethics committee reference number
IR.SEMUMS.REC.1397.154

Health conditions studied

1

Description of health condition studied
Schizophernia
ICD-10 code
F20
ICD-10 code description
Schizophernia

Primary outcomes

1

Description
Emotional Intelligence
Timepoint
Before and after therapeutic sessions
Method of measurement
Bar-an's Emotional Intelligence Questionnaire

2

Description
Cognitive regulation
Timepoint
Before and after therapeutic sessions
Method of measurement
Gravinsky Emotional Cognitive Setting Questionnaire

3

Description
Quality of Life
Timepoint
Before and after therapeutic sessions
Method of measurement
World Health Organization Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the experimental group, the therapeutic sessions begin with one another and begin with drama therapy. Each week, they will receive 3 sessions elects compulsive therapy sessions and drama theater. Drama therapy will be grouped in a 8-session program, 3 days a week for 60 minutes. And shock therapy sessions will be conducted in 6 sessions, 3 days a week
Category
Treatment - Other

2

Description
Control group: Electra compulsive therapy sessions are received in 6 sessions, 3 days a week
Category
Treatment - Other

3

Description
Control group: Drama therapy will receive 60 minutes in a 8-session program, 3 days a week
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Educational Hospital
Full name of responsible person
Mina sadat Mirshoja
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4180
Email
msj5831@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Scienes, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mina sadat Mirshoja
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23033654180
Email
msj5831@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mina sadat Mirshoja
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
5314799442
Phone
+98 23 3365 8041
Email
msj5831@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mina sadat Mirshoja
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Damghan Road, Semnan University of Medical Sciences, Faculty of Rehabilitation
City
Semnan
Province
Semnan
Postal code
5314799442
Phone
+98 23 3365 8041
Email
msj5831@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Reproductive in the field of rehabilitation and behavioral science
When the data will become available and for how long
1years
To whom data/document is available
Researchers
Under which criteria data/document could be used
Reproductive in the field of rehabilitation and behavioral science
From where data/document is obtainable
Semnan University of Medical Sciences
What processes are involved for a request to access data/document
نظارت کمیته تحقیقات دانشجویی دانشگاه علوم پزشکی سمنان- انجام تعهدات محقق اصلی
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