Determining the effect of spiritual intervention caused by a healthy heart on the self-care ability of stroke patients
Design
This study will be conducted as a clinical trial on stroke patients hospitalized in the neurology department of Golestan Ahvaz Hospital. The samples will be selected by the available method from the patients with stroke based on the inclusion criteria. The number of samples was calculated based on the formula for determining the sample size, including 10% attrition, and 86 people were randomly divided into two intervention and control groups using sealed envelopes.
Settings and conduct
This study will be conducted as a clinical trial on stroke patients hospitalized in the neurology department of Golestan Ahvaz Hospital in 1402.
Participants/Inclusion and exclusion criteria
1. Patients with stroke
2. Age above 18 to 80 years
3. Full awareness of time, place and people
4. Not being deaf to communicate effectively
Exclusion criteria include Refusal to participate in the study
Intervention groups
Spiritual intervention based on a healthy heart will be performed on the self-care ability of stroke patients in the intervention group.
Routine care intervention will be implemented in the control group.
Main outcome variables
Self-care ability obtained from the Canadian Work Performance Evaluation Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230729058961N1
Registration date:2023-08-26, 1402/06/04
Registration timing:registered_while_recruiting
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Zahra Elihaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8765 4321
Email address
zahraelihaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
2023-08-23, 1402/06/01
Actual recruitment end date
2024-03-18, 1402/12/28
Trial completion date
2024-03-18, 1402/12/28
Scientific title
The effect of healthy heary based spiritual intrevention on self care ability of patients with stroke
Public title
The effect of healthy heary based spiritual intrevention on self care ability of patients with stroke
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with stroke
Age above 18 to 80 years
Full awareness of time and space and love
Not being deaf to face communication
Exclusion criteria:
Refusal to participate in the study
Absence in more than one training session
Having an acute physical or mental illness
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
86
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
Jundishapur University of Ahvaz
Street address
No. 24, West 19th Street, kianpars, city ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155884339
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.AJUMS.REC.1402.170
Health conditions studied
1
Description of health condition studied
Patients with stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Self-care ability score obtained from the Canadian work performance evaluation scale
Timepoint
Measuring self-care capacity before the intervention and two months after the intervention
Method of measurement
Canadian work performance evaluation scale
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: The spiritual care program will be organized based on religious spirituality and based on the improvement of four human relationships (relationship with God, relationship with self, relationship with others and relationship with the environment) and taking into account the different levels of spirituality of individuals and the amount Their interest and the existential capacity of people, the type of intervention will be done according to the patient's choice and desire. The number and time of the sessions will be 5 sessions of 45-60 minutes during 5 weeks. Every day, all the contents of the previous day will be repeated and reminded. A telephone number will also be provided to the patients of the intervention group so that they can contact this telephone number at home and after discharge, in case of any problems or questions.
Category
Rehabilitation
2
Description
Control group: will receive routine ice care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Zahra elihaei
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6155884339
Phone
+98 933 666 2003
Email
Zahraelihaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra elihaei
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6155884339
Phone
+98 933 666 2003
Email
Zahraelihaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
0
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra elihaei
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6155884339
Phone
+98 933 666 2003
Email
Zahraelihaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra elihaei
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6155884339
Phone
+98 933 666 2003
Email
Zahraelihaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra elihaei
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6155884339
Phone
+98 933 666 2003
Email
Zahraelihaei@gmail.com
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
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