The Effect of Education According to Roys Adaptation Model on the Quality of life of Family caregivers of Mental patients with a History of Admission to Mental Hospitals of Armed Force
This study aimed to investigate the effect of education based on the adaptive pattern on the quality of life of home-care carers in psychiatric patients.
Design
Clinical randomized controlled trials
Settings and conduct
A total of 50 home caregivers , military hospitals in Bushehr,available sampling method, two groups of tests and control. Quality of care was assessed by Sf-36 quality of life questionnaire before and one month after intervention. Data were analyzed using Spss software.
Participants/Inclusion and exclusion criteria
Inclusion criteria include the first-degree dependent who is the main caregiver and lives with the patient at home, with cyclical upsurges, having informed consent for participation in the study, having a child aged between 20-60 years without any physical defects, mental illness Or taking mental drugs, addiction and misinformation, the absence of another crisis, such as the divorce or death of loved ones in the last six months, and the care of a patient with a history of hospitalization in military hospitals. Exit criteria for absenteeism in more than one session, other critical events such as divorce or death of loved ones, participation in another educational program and reluctance to continue studying
Intervention groups
Educational intervention is performed in the experimental group. In the control group, no intervention will be performed
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042566N1
Registration date:2019-02-22, 1397/12/03
Registration timing:retrospective
Last update:2019-02-22, 1397/12/03
Update count:0
Registration date
2019-02-22, 1397/12/03
Registrant information
Name
Sahar Nezameslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3344 6894
Email address
saharnezameslami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-27, 1397/08/05
Expected recruitment end date
2018-12-26, 1397/10/05
Actual recruitment start date
2018-10-27, 1397/08/05
Actual recruitment end date
2018-12-26, 1397/10/05
Trial completion date
2019-01-25, 1397/11/05
Scientific title
The Effect of Education According to Roys Adaptation Model on the Quality of life of Family caregivers of Mental patients with a History of Admission to Mental Hospitals of Armed Force
Public title
The effect of education of Roy adaptation model on quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having ages 20-60 years
Without any mental disorder or mental illness, addiction and background
There is no other crisis such as the divorce or death of loved ones in the last six months
The care of a mental disorder with a history of admission to military hospital
Exclusion criteria:
A family member who has previously been trained in adaptive behavior
A member of the family who is undergoing neuro-psychological treatment
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a random number table in such a way that two rows of rows and columns were arranged from 01 to 50, then by rotating the pencil tip of the selected numbers up to 25 persons were assigned to the control group. The remaining 25 were placed in the test group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
50 subjects were randomly assigned to randomly assigned to two groups of test and control. The training test group was based on the adaptive pattern
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Aja of Medical Science
Street address
Navy Base,Bushehr
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۸۶۳۳۱۱۳
Approval date
2018-12-23, 1397/10/02
Ethics committee reference number
IR.AJAUMS.REC.1397.064
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
Beginning of study and one month after the intervention
Method of measurement
Quality of life questionnaire Sf-36
Secondary outcomes
empty
Intervention groups
1
Description
An average weekly education was provided for 90 minutes in five consecutive sessions by an experienced researcher (nursing masters) and a clinical psychologist. All participants in the test group were trained in one class. Educational sessions were presented through lectures, questions and answers, discussion and discussion, expression of experiences, thoughts and feelings of caregivers about life with mental patients and giving educational pamphlets. The tool used for teaching slides and the place of training for the auditorium of Khatam-ol-Anbia Hospital was Navy .Educational materials in the field of incompatible behaviors include how to deal with the behavioral problems of psychiatric patients such as aggression, isolation and confinement, suicide and intercourse, sleep disorders and nutrition, irritability, hallucinations and delusions, measures when refusing the patient Drug use, anxiety and patient fears, family planning interventions, social skills, and apprenticeships. Also, training was provided in the form of a variety of psychiatric disorders, drug treatments and drug-related side effects, and measures taken before and after non-pharmacological treatments such as ect.
Category
N/A
2
Description
Control group: Home careers do not receive psychological intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
khatamolanbia Naval force hospital
Full name of responsible person
Sahar Nezameslami
Street address
Navy base., Bushehr
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۸۶۳۳۱۱۳
Phone
+98 77 3344 6894
Email
saharnezameslami@yahoo.com
2
Recruitment center
Name of recruitment center
Amiralmomnin hospital of Air force
Full name of responsible person
Sahar Nezameslami
Street address
Air forc base,
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۸۶۳۳۱۱۳
Phone
+98 77 3154 2072
Email
saharnezameslami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr- Armin Zareeian
Street address
Etemad zadeh st,AJA university of Medical science
City
Tehran
Province
Tehran
Postal code
۷۵۱۸۶۳۳۱۱۳
Phone
+98 21 4382 2353
Email
f.soltannezhad@ajaums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Sahar Nezameslami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Navy base, Bushehr
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۸۶۳۳۱۱۳
Phone
+98 77 3344 6894
Email
saharnezameslami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sahar Nezameslami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Navy base, Bushehr
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۸۶۳۳۳۱۱۳
Phone
+98 77 3344 6894
Email
saharnezameslami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sahar Nezameslami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Navy base , Bushehr
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۸۶۳۳۱۱۳
Phone
+98 77 3344 6894
Email
saharnezamrslami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Tables of dimensions of quality of life and demographic variables
When the data will become available and for how long
2019
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Nurses can use data and analysis methods
From where data/document is obtainable
saharnezameslami@yahoo.com
What processes are involved for a request to access data/document
Having a student card with a student number, or a valid university identification card