The aim of this study was to improve the performance and quality of life of patients with schizophrenia. This is a two-group clinical trial, three-step, and one-blind clinical trial. In this study, 70 people with schizophrenia who are eligible for inclusion in the study are selected through simple random sampling in two groups of test and control. At least two years of history of schizophrenia and having criteria for discharge and the ability to attend educational sessions are the most important criteria for entering this study, if for any reason, patients have more than two absenteeism sessions. The data gathering tool was a questionnaire on the quality of life of schizophrenic patients and general performance that was completed by the two groups in three stages before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072835350N1
Registration date:2017-08-23, 1396/06/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-23, 1396/06/01
Registrant information
Name
Sara Khalatbari Zamanpour
Name of organization / entity
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 8424
Email address
s.khalatbari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of The effect of a self-care program based on Orem's theory on the performance and quality of life of schizophrenic patients
Public title
The effect of self-care program based on Orem's theory on the performance and quality of life of schizophrenic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for entering the study:
1. Have at least 2 years of history of chronic schizophrenia.
2. Have a willingness to participate in the research.
3-Minimum age for participation in the research is 18 years and maximum 50 years. (Jahansari et al., 2011)
4. Be able to communicate and read and write in Persian.
5-Examples have the ability to understand the content provided in the training classes (according to the psychiatrist's approved insight) and have the consent to participate in the study. (Jansari et al., 2011)
6. The selected samples are admitted to hospital and have criteria for discharge (criteria for returning to society) according to the psychiatrist.
7. Confirmation of the diagnosis of schizophrenia by a psychiatrist based on DSM-5 criteria in the chronic phase of the disease. (Jansari et al., 2011)
8. Do not have drug addiction and do not treat psychosocial drugs.
9.Do not Have participated in any training project in this area before.
10-Do not have physical features that cause a functional impairment.
Exit criteria:
1-The inability of a regular company to attend meetings (having more than two meetings absent)
2. The patient does not want to continue co-operation in educational sessions.
3. Suicide or death during the study.
4. The occurrence of stressful events in divorce and suicide is such that the level of their stress and anxiety according to the Holmes table and Rahe to patients during the study is more than 150.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Isfahan University of Medical Sciences, College of Nursing and Midwifery
Secondary trial Id
IR.MUI.REC.1396.3.210
Registration date
1396-01-03, 777/01/-806
Ethics committees
1
Ethics committee
Name of ethics committee
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Street address
Azadi Square, Hezarjarib street
City
Esfahan
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
396210
2
Ethics committee
Name of ethics committee
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Street address
Azadi Square, Hezarjarib street
City
Esfahan
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
396210
3
Ethics committee
Name of ethics committee
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Street address
Azadi Square, Hezarjarib street
City
Esfahan
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
396210
Health conditions studied
1
Description of health condition studied
Schizophrenia disorder
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Overall performance
Timepoint
Before the intervention, one month later and three months after the intervention
Method of measurement
General Performance Questionnaire
Secondary outcomes
1
Description
Quality of Life in Schizophrenic Patients
Timepoint
Before the intervention, one month later and three months after the intervention
Method of measurement
The quality of life questionnaire for schizophrenic patients
Intervention groups
1
Description
The researcher will set up his intervention program based on the Orem-based self-care plan and will act as a supportive educational intervention in eight 90-minute sessions, twice a week for patients with schizophrenia, who have criteria Clearance and Eligibility.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Specialized and Advanced Hospital
Full name of responsible person
Sara Khalatbari Zamanpour(Researcher)
Street address
Bozorg Mehr Bridge, Mashhagh Third Street, Arghavani Blvd.
City
Esfahan
2
Recruitment center
Name of recruitment center
Noor Medical Center and Ali Asghar (AS)
Full name of responsible person
Sara Khalatbari Zamanpour(Researcher)
Street address
Imam Hussein Square, Ostandari Square
City
Esfahan
3
Recruitment center
Name of recruitment center
Ayatollah Madras Medical Center
Full name of responsible person
Sara Khalatbari Zamanpour(Researcher)
Street address
18 km of Esfahan Road, Najaf Abad, at the beginning of Goldschat
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Sara Khalatbari Zamanpour
Street address
Azadi Square, Hezarjarib street
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
College of Nursing and Midwifery, Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Saeed Pahlavanzade
Position
Master of Psychiatric Nursing, Faculty Member of Department of Psychiatric Nursing, Faculty of Nursi
Other areas of specialty/work
Street address
Azadi Square, Hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3668 7124
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery