Determining the effect of spiritual care based on Ghalbe Salim on anxiety related to COVID-19 in working women of Larestan offices in 2020
Design
Randomized Clinical Trial with control and intervention group. parallel groups without blindness. on 28 working women in Larestan offices
Settings and conduct
The present study was performed on working women in Larestan offices .
Participants/Inclusion and exclusion criteria
Admission requirements: Be a woman and work in government offices.
Exit conditions: Do not have the necessary conditions to do homework and accompany the program.
Intervention groups
The program of spiritual intervention based on Ghalbe Salim was based on Islamic verses and hadiths and approved by religious experts. This program included presenting solutions in four areas as follows :
A) Communication with God
B) Communication with yourself
C) Communication with others
D) Relationship with nature and environment
After identifying the members of the intervention group, 6 virtual 60-minute sessions were held.
The agenda of the meetings was as follows:
1.Expressing the content identified by researchers in a variety of ways, including playing short videos, audio and text for 20 to 30 minutes
2.Specify the task of the next session includes writing your opinion on a specific spiritual subject, doing a practical task such as doing a particular act of worship and expressing your feelings about it, and so on.
3.Questions and answers and summarizing the contents and feedback of the homework of the previous session for 20 minutes.
The control group was selected from the same participants who had the inclusion criteria.The control group did not receive any intervention.
Main outcome variables
After the intervention, the Corona Anxiety Scale Questionnaire was completed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201003048905N1
Registration date:2020-10-07, 1399/07/16
Registration timing:retrospective
Last update:2020-10-07, 1399/07/16
Update count:0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Zohreh Faramarzian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 9506
Email address
zohreh.faramarzian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-23, 1399/03/03
Expected recruitment end date
2020-07-03, 1399/04/13
Actual recruitment start date
2020-06-13, 1399/03/24
Actual recruitment end date
2020-07-24, 1399/05/03
Trial completion date
2020-07-31, 1399/05/10
Scientific title
Effect of spiritual care based on Ghalbe Salim on anxiety related to COVID-19 (corona phobia) in working women of Larestan offices in 2020
Public title
Effect of spiritual care based on Ghalbe Salim on anxiety related to COVID-19 (corona phobia)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Do not have acute family problems.
Have an interest and desire to participate in meetings.
Have no history of diagnosed mental illness (depression, violence, etc.).
Exclusion criteria:
Withdrawal from continuing cooperation during the study
Absence from more than one session of interventions
Failure to perform assigned tasks in more than one session
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Actual sample size reached:
14
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher extracts the list of government offices in Larestan by referring to Larestan city governor's office and writes the name of each office on a piece of paper. In the next step, the papers are entered into the envelopes and 7 envelopes are selected through simple random sampling. Therefore, 7departments are selected for sampling up to this stage. In the next step, the researcher provides ethical and scientific permission to the city governor to write letters to selected departments.
Researcher explains the goals of the plan as well as the criteria for entering and leaving the study and requests from selected departments to introduce 4 working women who wants to participate in the present study through the contact number.
Individuals are divided into 7 blocks of 4 by contacting the researcher and randomly assigning random blocks.
Therefore, in each block, 2 people are assigned to the intervention group and 2 people to the control group
Finally, 14 women are in the intervention group and 14 women are in the control group.
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 Larestan University of Medical Sciences
Street address
Fars, Larestan, Shahr-e Jadid, North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
City
larestan
Province
Fars
Postal code
7431889629
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.LARUMS.REC.1399.001
Health conditions studied
1
Description of health condition studied
anxiety related to corona disease (coronaphobia)
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety related to COVID-19 ( corona phobia )
Timepoint
At the beginning of the study and after the study
Method of measurement
Corona Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : The program of spiritual intervention based on Ghalbe Salim, which is based on Islamic verses and hadiths and approved by religious experts, is developed in four areas and includes the following: A) Communication with God B) Communication wit yourself. C) Communication with others. D) Relationship with nature and environment. The program was presented in 6 sessions as follows: Session 1: Initial evaluation, welcome, explanation of group rules, statement of goals and structure of meetings, initial evaluation feedback, program implementation Session 2: Implement the program to provide solutions to strengthen the relationship with God. Session 3: Implement the program to provide solutions to strengthen self-communication. Sessions 4 and 5: Implement the program to provide solutions to strengthen relationships with others. Session 6: Presenting solutions to strengthen the relationship with the environment and nature and summarizing the previous sessions
Category
Lifestyle
2
Description
The "Control group" will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Larestan offices
Full name of responsible person
Zohreh Faramarzian
Street address
Fars Province, Larestan, New City, Dr. Dadman Highway, Next to Imam Reza Hospital, Hazrat Zeinab School of Nursing and Midwifery, Teacher's Office
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Email
zohreh.faramarzian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr Behzad Rezaie
Street address
Fars, Larestan, Shahr-e Jadid, North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
zohreh.faramarzian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Zohreh Faramarzian
Position
Instructor-Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatric nursing
Street address
Fars Province, Larestan, New City, Dr. Dadman Highway, Next to Imam Reza Hospital, Hazrat Zeinab School of Nursing and Midwifery, Teacher's Office
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
Email
zohreh.faramarzian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Zohreh Faramarzian
Position
Instructor-Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatric nursing
Street address
Fars Province, Larestan, New City, Dr. Dadman Highway, Next to Imam Reza Hospital, Hazrat Zeinab School of Nursing and Midwifery, Teacher's Office
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
Email
zohreh.faramarzian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Zohreh Faramarzian
Position
Instructor-Faculty Member
Latest degree
Master
Other areas of specialty/work
Pediatric nursing
Street address
Fars Province, Larestan, New City, Dr. Dadman Highway, Next to Imam Reza Hospital, Hazrat Zeinab School of Nursing and Midwifery, Teacher's Office
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
Email
zohreh.faramarzian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It can be shared by unidentifiable participants.
When the data will become available and for how long
Access begins a year after the publication of results
To whom data/document is available
People who are working in the academic and scientific institutions
Under which criteria data/document could be used
it needs the agreement of Larestan University of Medical Sciences
From where data/document is obtainable
zohreh Faramarzian, Instructor, Larestan University of Medical Sciences, Email: zohreh.faramarzian@gmail.com
Contact Phone:00987152245009
What processes are involved for a request to access data/document
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences