The effect of spiritual care on the quality of life of patients with stroke
Design
After obtaining permission, the researcher goes to the relevant center to select samples. The sampling method is random and based on coin toss
Settings and conduct
In this study, spiritual care will be performed individually and twice a week in the morning or afternoon shifts at the patient's personal home. A landline and mobile phone number will be taken from the patient or the patient's companion to follow up and ask any questions about the disease. The control group is not given any training. One month after the completion of the educational intervention, the Stroke Quality of Life Scale questionnaire will be completed by both intervention and control groups.
Participants/Inclusion and exclusion criteria
Patients between the ages of 18-60. Patients who are conscious and oriented. Be able to speak Persian. Do not have severe hearing and vision impairment. Willing to participate in the study. The patient has no history of mental illness. The patient has no history of hospitalization due to stroke. The patient has the ability to self-care and more than 48 hours have passed since the onset of cerebral haemorrhage (acute stage).
Exclusion criteria: The patient's unwillingness to continue participating in the study for any reason. Perform any procedure outside the routine program. Illness for any reason Death of the patient
Intervention groups
In the intervention group, the spiritual care model is trained for 90 minutes in the patient's personal home for seven sessions in each session. Then, two weeks and one month after the end of the training, a quality of life questionnaire will be provided to patients.
Main outcome variables
Improving and improving the quality of life of patients with stroke
General information
Reason for update
Acronym
SQP
IRCT registration information
IRCT registration number:IRCT20161116030926N9
Registration date:2022-01-19, 1400/10/29
Registration timing:prospective
Last update:2022-01-19, 1400/10/29
Update count:0
Registration date
2022-01-19, 1400/10/29
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
alilu@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care on the quality of life of patients with stroke
Public title
The effect of spiritual care on the quality of life of patients with stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are between the age group of 18-60. Patients who are alert and oriented. Have the ability to speak Persian. Do not have severe hearing and vision impairment. Have a desire to participate in the study. The patient has no history of mental illness. The patient does not have a history of hospitalization due to stroke.
Exclusion criteria:
The patient's unwillingness to continue participating in the study for any reason. Perform any procedure outside the routine program. Illness for any reason Death of the patient
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is by using coin toss, so that the line intervention group and the valve control group are considered and the coin will be tossed according to the desired sample size.
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
Urmia University of Medical Sciences
Street address
South Khayyam Street
City
Urmia
Province
West Azarbaijan
Postal code
5951973896
Approval date
2022-01-01, 1400/10/11
Ethics committee reference number
IR.UMSU.REC.1400.388
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
In this study, the SS-QoL (Stroke-Specific Quality of Life scale) quality scale will be used to determine the quality of life of a patient rescued from a stroke. This questionnaire consists of 12 items, each of which represents a major dimension of the 12 dimensions of SS-QOL. The answer is 2 methods, for the first group (physical) the answer is 1 - I can not do at all 2- I do very hard 3- I do a little hard 4- I do hard 5- I do without effort. For group 2, which is the psycho-social dimension, answering as 1- I totally agree 2- I slightly agree 3- I have no opinion 4- I slightly disagree 5- I strongly disagree The minimum score will be 12 and the maximum score will be 60 And a higher score will indicate a better quality of life
Timepoint
Two weeks and one month after the intervention
Method of measurement
By quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consists of 50 people who are randomly selected by tossing a coin. Patients will enter the study phase after discharge. Also in this study, spiritual care will be performed individually and twice a week in the morning or evening shifts, in the patient's private home for seven sessions and for 90 minutes. Also, in order to have a greater impact and improve the quality of education, the guidance and advice of Dr. Heiman Mohammad Fakheh (PhD in Psychology) will be used. A landline or mobile phone number will be taken from the patient or the patient's companion to follow up and ask any questions about the disease.
Category
Lifestyle
2
Description
Control group: They do not receive any training.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Urmia
Full name of responsible person
Leila Alilo
Street address
Urmia - Resalat Boulevard - Emergency Alley - Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5951973896
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
aliluleyla@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Alilo
Street address
Urmia - Resalat Boulevard - Emergency Alley - Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5951973896
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
aliluleyla@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Leila Alilo
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ارومیه - بلوار رسالت - کوی اورژانس - دانشگاه علوم پزشکی ارومیه
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Fax
+98 44 3223 4897
Email
aliluleyla@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Alilo
Position
ph.d
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Urmia - Resalat Boulevard - Emergency Alley - Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
aliluleyla@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leila Alilo
Position
ph.d
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Resalat Boulevard - Emergency Alley - University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5951973896
Phone
+98 44 3223 4897
Email
aliluleyla@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
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
It is available to everyone as an educational pamphlet
When the data will become available and for how long
One year after printing
To whom data/document is available
All stroke patients
Under which criteria data/document could be used
Charter to improve the quality of life and stroke patients
From where data/document is obtainable
Author
What processes are involved for a request to access data/document