Determining the effect of using spiritual care program on sleep quality and Spiritual health of patients with stroke
Design
The present study is a randomized two-group clinical trial study that will be performed with the participation of 112 patients. The research units will be selected by available sampling method and permuted block method divided into two groups of control and test.
Settings and conduct
The present study is a randomized two-group clinical trial with the participation of 112 patients with stroke in Hamadan. In the intervention group, group sessions of the spiritual care program will be held in 4 sessions, one session per week for 45 to 60 minutes by the researcher. The topics of the sessions will include assessing the spiritual needs of patients with stroke, religious care for stroke patients, spiritual care-support for stroke patients, and evaluation of spiritual care, respectively. The patients' hope questionnaire will be administered one month after the last care session. The control group will receive only routine medical care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of adult stroke according to the doctor; not having mental disorders; lack of vision and hearing diseases. Exclusion criteria: hospitalization of the patient due to recurrence of the disease; absence more than once in meetings; reluctance to continue participating in the study.
Intervention groups
Intervention group: the group sessions of the spiritual care program will be held by the researcher for the intervention group during 4 sessions, 1 session per week for 45 to 60 minutes. Assessment of patients' hope after spiritual care intervention will be done one month after the last care session. Control group: patients in the control group will receive only routine care.
Main outcome variables
sleep quality and Spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211227053551N1
Registration date:2022-01-03, 1400/10/13
Registration timing:prospective
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
ٰٰVahid Yousofvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3252 6339
Email address
v.yousofvand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
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 using spiritual care program on sleep quality and Spiritual health of patients with stroke
Public title
The effect of spiritual care program on sleep quality and Spiritual health
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of stroke according to the doctor
Not having mental disorders
Lack of vision and hearing diseases
Exclusion criteria:
Hospitalization of the patient due to recurrence of the disease
Absence more than once in meetings
Reluctance to continue participating in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the patients were registered according to the sample size (112) and according to the inclusion criteria, and using the blocking method (using a two-block method, two letters A and B with different permutations we place in blocks and randomly select 56 blocks and assign each block to 2 people) will be assigned to two groups.
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
کمیته اخلاق دانشگاه علوم پزشکی همدان
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.UMSHA.REC.1400.711
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67.81
ICD-10 code description
Acute cerebrovascular insufficiency
Primary outcomes
1
Description
Patients' sleep quality and Spiritual health
Timepoint
One month after the intervention
Method of measurement
Patients' Pittsburgh Sleep Quality and Paloutzian and Ellison Spiritual health questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group sessions of the spiritual care program will be held in 4 sessions, one session per week for 45 to 60 minutes by the researcher. The content of these sessions has been localized due to the identification of the spiritual needs of Iranian patients and its adaptation to the international clinical guide and texts related to spiritual care, through a group agreement of Iranian health system experts. The Patients' sleep quality and Spiritual health Questionnaire will be administered one month after the last care session.
Category
N/A
2
Description
Control group: the control group will receive only routine medical care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Azim Azizi
Street address
Shahid Beheshti Blvd., Besat hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 918 107 0758
Email
azimazizi1360@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Hamadan University of Medical Sciences, ُShahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, ُShahid Fahmideh St.
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
azimazizi1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, ُShahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
azimazizi1360@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vahid Yousofvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, ُShahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
v.yousofvand@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