Determining the effectiveness of the intervention to improve the level of resilience of nurses working in the COVID-19 wards
Design
Clinical trial with control group, parallel design, single blind, randomized, on 90 nurses. A table of random numbers was used for randomization.
Settings and conduct
From the total number of nurses working in Imam Hasan Hospital in Bojnourd city who meet the criteria for entering the study, the calculated sample size (90 people), the research units in each department were assigned to each of the intervention and control groups by random allocation based on the table of random numbers. Both groups complete Connor Davidson's resilience and Meslich's burnout, and Kessler's psychological distress questionnaires.
Nurses in the intervention group will receive a 4-week resilience training program on the web. Nurses of both groups complete resilience and burnout questionnaires in week 4 (after the end of the training program) and one month later. The control group will receive the training program after the end of the second post-test.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Willingness to participate in the study
• Having at least a bachelor's degree in nursing
• Work experience in the COVID-19 departments
. A resilience scores lower than 75 on the Connor Davidson scale - 25.
Exclusion criteria:
Participation in programs aimed at promoting resilience in the past six months
Intervention groups
The intervention group will receive the resilience-building skills training program online for four weeks.
The control group will receive the intervention program after the end of the follow-up (second post-test).
Main outcome variables
Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240222061081N1
Registration date:2024-05-19, 1403/02/30
Registration timing:registered_while_recruiting
Last update:2024-05-19, 1403/02/30
Update count:0
Registration date
2024-05-19, 1403/02/30
Registrant information
Name
Tooba Hoseini Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 0358
Email address
t-hoseiniazizi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the perception resilience in front line nurses in COVID-19 and designing, implementation and evaluation an intervention to improve it
Public title
Improving nurses resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Bachelor's degree in nursing
Work experience in the COVID-19 departments
A resilience score lower than75 of the Connor Davidson scale 25
Exclusion criteria:
Participation in resilience promotion programs in the last year
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Nurses who meet the inclusion criteria in each department of the hospital are randomly assigned to the intervention or control group. Randomization is done in such a way that the nurses included in the study are listed in the Excel software in alphabetical order, separately from each hospital department. Equal to the number of nurses eligible to enter in each department, a two-digit number is selected from the table of random numbers and assigned to each code respectively. It is agreed that odd numbers are in the control group and even numbers are in the intervention group. The intervention is participation in the educational program and there is no possibility of blinding the participants and researchers.
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 Tehran University of Medical Sciences
Street address
Nursing and midwifery faculty, Mir Khani street,Towhid square,
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.TUMS.FNM.REC.1400.031
Health conditions studied
1
Description of health condition studied
Resilience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
resilience
Timepoint
Time 0, 4 week, 8 week
Method of measurement
Connor-Davidson Resilience Scale (CD-RISC) 25
Secondary outcomes
1
Description
Burn out
Timepoint
Time 0, Week 4, Week 8
Method of measurement
Maslach Burnout Inventory (MBI)
Intervention groups
1
Description
Intervention group: They take the resilience building skills training course online for 4 weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hasan Hospital
Full name of responsible person
Tooba Hoseini Azizi
Street address
Imam Hasan Hospital, Arkan road, Bjnourd, North Khorasan
City
Bojnourd
Province
North Khorasan
Postal code
9453151744
Phone
+98 58 3151 4011
Email
hoseini.tooba@gmail.com
Web page address
https://imamhasan.nkums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor, corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Bojnourd University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahriar Blvd
City
Bojnourd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Email
Hoseini.tooba@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing faculty, Shahriyar Blv.
City
Bojnourd
Province
North Khorasan
Postal code
9414635666
Phone
+98 58 3225 0358
Fax
Email
t-hoseiniazizi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Tooba Hoseini Azizi
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing faculty, Shahriar Blvd., Bojnourd, North Khorasan
City
Bojnourd
Province
North Khorasan
Postal code
9417696786
Phone
+98 58 3229 7096
Email
Hoseini.tooba@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All personal data of participants can be published after de-identification.
When the data will become available and for how long
After the design and data analysis are finished, the documentation will be published as an article.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data will be used only for the purpose of evidence for carrying out retraining and management programs for nurses.
From where data/document is obtainable
Contact the corresponding of this clinical trial via email.
What processes are involved for a request to access data/document
A reply will be given within two weeks after emailing the corresponding person.