Determining the Impact of Spiritual-Religious Care Program on Public Health and Life Satisfaction of Hospitalized Veterans with Covid-19 Diagnosis.
Design
A clinical trial with two intervention and comparison groups, a blind, randomized, block-assisted strain will be performed on 70 patients with Covid.
Settings and conduct
This clinical trial will be performed at Sasan Hospital in Tehran. This study is a one-way blind and the data analyzer in this study is blind. Participants include veterans with Covid-19.
Participants/Inclusion and exclusion criteria
Entry requirements:
Be a veteran (reviewed by the Medical Commission of the Martyr and Veterans Affairs Foundation and received the percentage of veterans).
Veterans who have a corona test reported positive by PCR and clinical diagnosis by imaging and diagnosed by a Quid-19 physician.
Be admitted to the ward.
Be vigilant and have GCS = 15/15.
The patient should be hospitalized on the first day.
Not having any clinical condition, such as diagnosed neurological problems, that affects a person's ability to participate in a spiritual-religious care program.
No entry:
Any clinical condition such as drowsiness or level of consciousness below 15 that may occur after enrollment and restrict the patient during caregiving exercises.
The patient becomes ill at the beginning of the study or within the first 48 hours and is transferred to the ICU.
The patient dies within the first 48 hours of the study.
Intervention groups
In this study, participants are divided into two groups of intervention and comparison. In the intervention group, patients will be taught spiritual-religious care, in the comparison group, patients will receive only their usual treatments.
Main outcome variables
Blood oxygen level; fever; heart beat; blood pressure; General Health Questionnaire SF12; Life Satisfaction Questionnaire; Spiritual care.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210227050517N1
Registration date:2021-06-26, 1400/04/05
Registration timing:prospective
Last update:2021-06-26, 1400/04/05
Update count:0
Registration date
2021-06-26, 1400/04/05
Registrant information
Name
Raheleh Mahdavitaree
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3355 4128
Email address
mahdavi.raheleh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Spiritual-Religious Practice on Public Health and Life Satisfaction of War Survivors Hospitalized Due to Covid-19
Public title
Investigating the Effect of Spiritual-Religious Practice on Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be a veteran (reviewed by the Medical Commission of the Martyr and Veterans Affairs Foundation and received the percentage of veterans).
PCR is positive.
Be in the ward.
Be vigilant.
The patient should be hospitalized on the first day.
Lack of any clinical condition such as diagnosed neurological problems that affect a person's ability to participate in a spiritual-religious care program.
Exclusion criteria:
Any clinical condition such as drowsiness or level of consciousness below 15 that may occur after enrollment and restrict the patient during caregiving exercises.
The patient becomes ill at the beginning of the study or within the first 48 hours and is transferred to the ICU.
The patient dies within the first 48 hours of the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were first divided into two groups: less than 60 years and 60 years and more. Then, in order to assign the patient to the intervention or control group in this study, the method of randomization blocks with a volume of 4 was used. These blocks were prepared in R software using the blockrand package. If there is an admission order in the file of each patient, the patient who accepts the conditions for admission to the study, if the patient is 60 years and older, enters the study using randomly defined blocks of volume 4 for people 60 years and older And if he is less than 60 years old, he enters the study using other randomly defined blocks for people under 60 years old. The patient is assigned to the intervention or comparison group in the same way according to the random table, and the next individuals are included in the study in the same way according to the random table. There is no concealment in this study.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patient and the researcher are in the intervention and comparison group, while the other members, including the clinical caregiver, outcome assessor, and data analyzer, do not know which patients are in which study group.
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 University of Medical Sciences
Street address
No. 11, Pish Namaz Alley, Mahallati Highway
City
Tehran
Province
Tehran
Postal code
1175875513
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.006
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
According to the General Health Questionnaire, the general health score will be measured in veterans with Covid-19 before and after the intervention. At the beginning of the study, a general health questionnaire will be completed for all participants. Then the intervention will be done. After the intervention, the general health questionnaire will be completed for the patients on the 30th day.
Timepoint
General health will be measured at the beginning of the study before the intervention and on the 30th day.
Method of measurement
Questionnaire 12-Item Short Form Survey
2
Description
Life satisfaction score according to life satisfaction questionnaire will be measured in veterans with Covid-19 before and after the intervention. At the beginning of the study, a life satisfaction questionnaire will be completed for all participants. Then the intervention will be done. After the intervention, the resuscitation satisfaction questionnaire for patients will be completed on the seventh day.
Timepoint
Life satisfaction will be measured at the beginning of the study before the intervention and on the seventh day.
Method of measurement
Satisfaction With Life Scale Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, participants are divided into two groups of intervention and control. The intervention group, in addition to the usual treatments prescribed by doctors in the hospital, receives a spiritual-religious care package that includes a seven-day period and three times a day reciting dhikr or Allah and Surah Hamad. Thus, the patient who has entered the intervention group for seven days should recite Surah Al-Hamd 3 times and Zikr Ya Allah 66 times every morning, noon and night. In order to remind, a table has been prepared that the patient enters in the table every time he recites the dhikr. Saying dhikrs is controlled and reminded daily by the researcher who is present in the hospital. The intervention is non-invasive and does not interfere with other treatment processes.
Category
Rehabilitation
2
Description
Control group: Control group: Patients in the control group receive only the usual treatments prescribed by doctors in the hospital.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sasan hospital
Full name of responsible person
Roghaye Esmaeeli
Street address
No.43, after the crossroads of Palestine, Keshavarz Boulevard,Valiasr Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1415983391
Phone
+98 21 8896 5170
Email
info@sasanhospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Ziyaee
Street address
Shahid Chamran Highway - Yemen St. - Shahid Abbas Arabi St. (Parvaneh) - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Health Services - Headquarters Building 2- Floor 5- Deputy of Research and Technology
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raheleh Mahdavitaree
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, Pish Namaz Alley, 17 Shahrivar St., Tehran
City
Tehran
Province
Tehran
Postal code
1175875513
Phone
+98 21 3355 4128
Email
mahdavi.raheleh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raheleh Mahdavitaree
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, Pish Namaz Alley, 17 Shahrivar St., Tehran
City
Tehran
Province
Tehran
Postal code
1175875513
Phone
+98 21 3355 4128
Email
mahdavi.raheleh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raheleh Mahdavitaree
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11, Pish Namaz Alley, 17 Shahrivar St., Tehran
City
Tehran
Province
Tehran
Postal code
1175875513
Phone
+98 21 3355 4128
Email
mahdavi.raheleh@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
There is no more information.
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
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The final report of this study will be published as an article after the end of the study and data analysis.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
No access restrictions.
Under which criteria data/document could be used
The final report of this study will be published as an article and will be made available to the public.
From where data/document is obtainable
mahdavi.raheleh@gmail.com
What processes are involved for a request to access data/document
The final report will be available as an article in the Journal of Veteran Medicine.