Investigating the effect of empowerment program based on spirituality on care burden and health-related quality of life of stroke patients family caregivers
Determining the impact of empowerment program based on spirituality on care burden and quality of life related to the health of family caregivers of stroke patients
Design
A clinical trial with control and intervention groups, with cross-over groups, single-blind, randomized, phase 3 on 96 family caregivers, coin toss was used for randomization.
Settings and conduct
The research environment is the place and situation where the data collection of a study takes place. In this study, the research environment will be the neurology department of hospitals affiliated to Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Having minimum literacy in Persian language؛ A family caregiver who is in the treatment team
Intervention groups
Spiritual intervention on family caregivers of stroke patients who will be divided into two intervention and control groups.
Main outcome variables
Caregiving burden; health-related quality of life
General information
Reason for update
Acronym
TSBQ
IRCT registration information
IRCT registration number:IRCT20230810059109N1
Registration date:2023-08-15, 1402/05/24
Registration timing:prospective
Last update:2023-08-15, 1402/05/24
Update count:0
Registration date
2023-08-15, 1402/05/24
Registrant information
Name
kosar pourhasan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3633 3128
Email address
kosarpourhasan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of empowerment program based on spirituality on care burden and health-related quality of life of stroke patients family caregivers
Public title
Investigating the effect of empowerment program based on spirituality on care burden and health-related quality of life of stroke patients family caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having minimum literacy in Persian language
Age above 18 years
Not taking drugs related to depression or psychosis according to the family caregiver
First or second degree family member including spouse, child, sister, brother, daughter-in-law, son-in-law
Having a smartphone and the possibility of installing internal messengers
Lack of family care as treatment staff
Failure to participate in similar training courses
Exclusion criteria:
Family caregivers should not be Muslim
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples will be entered into the study by the available method as individual units and by simple randomization and coin toss and will be allocated to two intervention and control groups. In order not to meet the control group with the intervention group for the purpose of concealment, we first sample the control group and then the intervention group.
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 Shahid Beheshti Faculty of Nursing and Midwifery
Street address
Tehran Province , Tajrish, Velenjak , 7 th Floor , Blong No.
City
Tehran
Province
Tehran
Postal code
1996835919
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.072
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
Z82.3
ICD-10 code description
Family history of ischaemic heart disease and other diseases of the circulatory system
Primary outcomes
1
Description
Caregiving burden of health-related quality of life
Timepoint
before the intervention and 3 weeks after the intervention
Method of measurement
In this study, the care burden variable is the burden of burden questionnaire and the health-related quality of life variable is the 12-question quality of life questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is carried out in the form of educational content, pamphlets, educational videos in the form of one-on-one sessions for 30 minutes once a week
Category
Rehabilitation
2
Description
Control group: In this group, after the end of the intervention in the test group, which will last for 3 months. After 3 months, the educational content will be provided to the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofaydeh Rehabilitation Center
Full name of responsible person
Kosar Pourhasan
Street address
Tehran Province, Tajrish , Velenjak 7 th Floor , Blong No
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
Kosarpourhasan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Vahid Zamanzade
Street address
Tehran Province , Tajrish , Velenjak , 7th Floor , Blong No
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
kosarpourhasan@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
shahid beheshti medical university
Proportion provided by this source
50
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kosar Pourhasan
Position
Master Of Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran Province , Tajrish , Velenjak , 7 th , Blong Floor
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
kosarpourhasan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kosar Pourhasan
Position
Master Of Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran Province , Tajrish , Velenjak , Blong FLoor, 7th
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
kosarpourhasan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kosar Pourhasan
Position
Master of Community Health Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran Province, Tajrish , Velenjak , Blong Floor , 7th
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
kosarpourhasan@sbmu.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Demographic and clinical questionnaire
When the data will become available and for how long
month 3
To whom data/document is available
reaserchers
Under which criteria data/document could be used
controlled conditions
From where data/document is obtainable
Kosarpourhasan's email, contact number 09147882954 and email: kosarpourhasan@sbmu.ac.ir
What processes are involved for a request to access data/document