Determining the Effect of Reality Therapy on the Anxiety and Stress of Family Caregivers of Stroke Patients
Design
Quasi-experimental Randomized Controlled Trial on 82 Family Caregivers of Stroke Patients
Settings and conduct
In this study,After obtaining the required permits family caregivers of patients who have the desire to participate and meet the inclusion criteria will be selected through the convenience sampling method, and they will be randomly allocated in control and intervention groups. Reality therapy skills will be taught face-to-face in 8 sessions at the 9th Dey Hospital in Torbat Heydarieh city. for the intervention group. After the end of the study, the skills taught to the intervention group will be provided to the control group during 8 training sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- To have the ability to understand and speak Persian.
2- Have the physical ability for interview and complete the questionnaire.
3- Absence of known mental illness
4- hearing health to participate in reality therapy sessions
Intervention groups
In this study, reality therapy skills will be taught face-to-face in 8 sessions for the intervention group. After the end of the study, the skills taught to the intervention group will be provided to the control group during 8 training sessions.
Main outcome variables
Anxiety and Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240526061900N1
Registration date:2024-06-15, 1403/03/26
Registration timing:prospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Reza Vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
rezavafaei935@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Reality Therapy on the Anxiety and Stress of Family Caregivers of Stroke Patients
Public title
Investigating the Effect of Reality Therapy on the Anxiety and Stress of Family Caregivers of Stroke Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
To have the ability to understand and speak Persian.
Have the physical ability for interview and complete the questionnaire.
Absence of known mental illness
hearing health to participate in reality therapy sessions
Exclusion criteria:
Impaired verbal and non-verbal communication
suffering from mental illness
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method will be as follows:
1)The size of each block will be 6.
2)All possible balanced combinations will be written with 3 control cases and 3 intervention cases. (20 combinations)
3)Blocks are randomly selected to allocate each 30 participants.
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 Birjand University of Medical Sciences
Street address
Ghafari Blvd.,Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2024-05-26, 1403/03/06
Ethics committee reference number
IR.BUMS.REC.1403.066
Health conditions studied
1
Description of health condition studied
Cerebrovascular Accident
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Anxiety
Timepoint
Before Starting the Intervention and After Completing the Intervention
Method of measurement
Beck Anxiety Questionnaire
2
Description
Stress
Timepoint
Before Starting the Intervention and After Completing the Intervention
Method of measurement
Tjomas Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, reality therapy skills will be taught face-to-face in 8 sessions for the intervention group. The educational content for each session is determined under the supervision of a mental health specialist, and each training session will be presented in 30 minutes.
Category
Rehabilitation
2
Description
Control group: After the end of the study, the skills taught to the intervention group will be provided to the control group during 8 sessions. The educational content for each session is determined under the supervision of a mental health specialist, and each training session will be presented in 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
9th Dey Hospital of Torbat Heydarieh
Full name of responsible person
Dr.Zahra Nikfarjam
Street address
Kashani Blvd.,9th Dey Hospital
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
951883166
Phone
+98 51 5222 6016
Email
Pr@thum.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Masoud Yousefi
Street address
Ghafari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
webda@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Reza Vafaei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, 28 th Mozafari Blvd.
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9717853076
Phone
+98 51 5223 1952
Email
Rezavafaei935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr.Davod Oudi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ghafari Blvd., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
webda@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Reza Vafaei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 19, 28 th Mozafari Blvd.,
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9717853076
Phone
+98 51 5223 1952
Email
Rezavafaei935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Baesd on Ethical Issues
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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