Protocol summary

Study aim
Determining the effect of educational intervention based on self-care strategies on self-compassion and COVID-19 prevention in nurses of Corona wards in hospitals related to Shahid Beheshti University of Medical Science in 1400.
Design
The clinical trial has a control group, not blinded, randomized, and on 80 nurses. Hospitals will randomly select and then the hospitals will be divided into two groups of intervention and control through block balanced randomization. Then, from each hospital, 10 nurses working in the corona ward will be selected through simple random sampling.
Settings and conduct
The research environment includes hospitals affiliated to Shahid Beheshti University of Medical Sciences in Tehran and then after random selection of samples, training will be provided individually based on self-care strategies in 6 relevant areas in accordance with the latest standard guidelines in intervention group
Participants/Inclusion and exclusion criteria
Inclusion criteria: To have physical health and the absence of underlying disease, Access to the Internet and social networks, No infection with COVID-19 during the last 6 months, Not participating simultaneously in similar classes or research to this research, Acquiescence to participate in research, To have bachelor certification at least. Exclusion criteria: Being infected by COVID-19 during last 6 months, Inaccessibility to internet or social media
Intervention groups
Intervention includes self-care training on self-compassion and COVID-19 prevention. This intervention will be performed in intervention group, and it will not be done in control group.
Main outcome variables
Determining and comparing the mean score of self-compassion and score of COVID-19 prevention, before and after the educational intervention based on self-care strategies in samples;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210925052567N1
Registration date: 2021-10-29, 1400/08/07
Registration timing: prospective

Last update: 2021-10-29, 1400/08/07
Update count: 0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Elahe Mehrabi Moshtaghin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7731 7659
Email address
elahemehrabi1995@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-02, 1400/08/11
Expected recruitment end date
2021-11-16, 1400/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention Based on Self-Care Strategies on Self-Compassion and COVID-19 Prevention in Nurses of Corona Wards in Hospitals Related to Shahid Beheshti University of Medical Science in 1400
Public title
The Effect of Educational Intervention Based on Self-Care Strategies on Self-Compassion and COVID-19 Prevention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have healthy physical appearance and the absence of underlying disease Access to the Internet and social networks Not being infected with Covid-19 during the last 6 months Not participating simultaneously in similar classes or researches to this research Consent to participate in research Bachelor certification at least
Exclusion criteria:
Being infected by COVID-19 during last 6 months Inaccessibility to the Internet and social networks Participating simultaneously in similar classes or researches to this research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, 8 hospitals related to Shahid Beheshti University of Medical Science will be selected through simple random sampling using graph pad random number calculator site and then the hospitals will be divided into two groups of intervention and control through block balanced randomization.To form the quadruple blocks, we write all the positions of the letters T and C together, which include the following: TTCC, TCTC, TCCT, CTTC, CTCT, CCTT T is the intervention group and C is the control group. Then we number these six states from one to six. To determine the number of required blocks, we divide the number of hospitals to the type of block (4), which in this study will be 2 blocks. From the table of random numbers, we select 6 random numbers from one to six and accordingly we choose from the blocks and based on this, the hospitals are divided into two groups of control and intervention. Finally from each hospital, 10 nurses working in the corona ward will be selected through simple random sampling using graph pad random number calculator site.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Regarding the assignment of study groups, since this study is a fixed size design, 40 people will be in the intervention group and 40 people in the control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Schools of Pharmacy, Nursing and Midwifery, Shahid Beheshti University of Medica
Street address
No. 2, Moghadas Ave., Sazman Ab Blvd., Halimiye Tehran
City
Tehran
Province
Tehran
Postal code
1759635173
Approval date
2021-09-20, 1400/06/29
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.133

Health conditions studied

1

Description of health condition studied
COVID-19 Prevention
ICD-10 code
U07. 1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Promoting self-compassion
Timepoint
At the beginning of the study, immediately after the study and one month after the study
Method of measurement
1-Demographic Information Questionnaire 2-Neff's Self-Compassion Scale (Long Form)

2

Description
corona prevention
Timepoint
At the beginning of the study, immediately after the study and one month after the study
Method of measurement
Coronavirus KAP Questionnaire (the knowledge, attitude and practice about coronavirus)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:If the sample is placed in the intervention group, self-care educational content will be provided for them via virtual messengers. Content will be sent to the intervention group 3 times (once a week). Questioning and answering will also be through the same virtual messaging system. Training is individual. In this educational intervention, different educational methods oral contact, written and combined methods such as speech (sending voice) with questioning and answering, practical demonstrations and written media presentation such as pamphlets or educational videos and slides will be used. The content of the training will be based on self-care strategies in 6 areas: physical, occupational, social, emotional, psychological and spiritual, which are according to the latest standard guidelines of the prevalence of Covid-19 epidemics.
Category
Prevention

2

Description
Control group: At the beginning of the study, questionnaires will be also given to the control group, but training will not be done in this group. In order to comply with ethical standards, educational content will be provided to the control group at the end of the study
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals under the auspices of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Meimanat Hosseini
Street address
No. 2, 7th Floor, SBUMS, Arabi Ave., Tehran, VelenjakTehran Province
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zatrghi
Street address
No. 2., Arabi Ave., Yaman Blvd., Velenjak., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@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
Dr Meimanat Hosseini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital,Tehran School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Meimanathosseini@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Meimanat Hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Tehran., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Meimanathosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elahe Mehrabi Moshtaghin
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 2, Moghadas Ave., Sazman Ab Blvd., Hakimiye., Tehran
City
Tehran
Province
Tehran
Postal code
1759635173
Phone
+98 21 7731 7659
Email
www.elahemehrabi1995@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the participant data sets are to be shared after individuals are unidentified
When the data will become available and for how long
Start access after printing
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to use the documents of this study, mentioning the name of the researchers of this study is essential.
From where data/document is obtainable
Applicants can receive the documents from the main researcher or the university and contact the main researcher via e-mail address (www.elahemehrabi1995@yahoo.com or www.meimanathosseini@yahoo.com) to receive the documents.
What processes are involved for a request to access data/document
Applicants can receive the files after submitting their request to receive the files via email to the main researcher (www.elahemehrabi1995@yahoo.com or www.meimanathosseini@yahoo.com).
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