Protocol summary

Study aim
To assess the effect of the meichenbaum coping with stress program training on nurses' resilience. To assess the effect of the meichenbaum coping with stress program training on nurses' bourn out.
Design
Two arm, parallel group, randomized controlled trial no blinding
Settings and conduct
This randomized controlled trial will be done in Imam Reza hospital in Kermanshah. Nurses will complete the job stress questionnaire. Then including criteria will be considered for selecting the sample. Samples will be assigned to the intervention and control groups by use of the quadruple block method. Then the intervention group will receive the 8-week-intervention. Both groups will complete the resilience and bourn out questionnaires before and two-month after the intervention.
Participants/Inclusion and exclusion criteria
Having a bachelor's degree in nursing and higher At least six months of nursing experience in a Corona hospital Having moderate stress levels and higher by completing the nurse's job stress questionnaire Not Including criteria Having neurological diseases and using psychiatric medicine according to the nurses' own preferences Having management position Having severe emotional crises in the last 6 months Taking part in retraining courses or workshops related to the present study
Intervention groups
The control group will not receive any intervention. The intervention group will receive 8-week- training meichenbaum stress coping program. This program is a cognitive-behavioral intervention and includes cognitive reconstruction techniques, problem-solving, relaxation training, mental and behavioral illustration practice, self-review, self-directed training, educational training, Socratic discussion, self-reinforcement, and actions to change the environment. The intervention will run during the 8-virtual- session both online and offline.
Main outcome variables
Resilience Burnout

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170218032635N4
Registration date: 2021-10-17, 1400/07/25
Registration timing: registered_while_recruiting

Last update: 2021-10-17, 1400/07/25
Update count: 0
Registration date
2021-10-17, 1400/07/25
Registrant information
Name
Afsaneh Sadooghiasl
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4875
Email address
asadooghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2022-02-14, 1400/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of meichenbaum coping with stress program training on resilience and burnout of nurses during the Covid19 epidemic
Public title
Effect of meichenbaum coping with stress program training on resilience and burnout of nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a bachelor's degree in nursing and higher At least six months of nursing experience in a Corona hospital Having moderate stress levels, and higher by completing nurses job stress questionnaire Not having neurological diseases according to the nurses' own preferences Lack of nursing management position (head nurse supervisor nursing manager) According to self reported coping with severe emotional crises in the last 6 months (death of loved ones, incurable disease, divorce, etc.) Do not participate in retraining courses or workshops related to the present study Do not use psychiatric drugs according to the nurses' preferences Satisfaction to participate in research
Exclusion criteria:
Age
From 22 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the quadruple block method to randomly assign individuals to control and test groups. In this method, we prepared a table of 4 blocks online. And we printed different modes on paper. For example AABB It was one of the modes. Then we wrote these letters on the form related to people, the first was A, then A, then B and last B. When a person is selected by sampling method and expresses his / her satisfaction with participating in the study. Thus the individual is assigned to his own group. This continues until the last person.
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 Tarbiat Modares University
Street address
Jalal Al Ahmad Bridge Nasr
City
tehran
Province
Tehran
Postal code
14115-111
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
R.MODARES.REC.1400.048

Health conditions studied

1

Description of health condition studied
ُStress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

Primary outcomes

1

Description
Resilience
Timepoint
Before and 2-month after completing the intervention.
Method of measurement
Connor and Davidson resilience questionnaire

2

Description
Burnout
Timepoint
Before and 2-month after completing the intervention.
Method of measurement
Maslach burnout questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive Mickenbaum stress coping program in 8-virtual-session and will complete the Nurses' Job Stress Questionnaire before the intervention and the Resilience and Burnout Questionnaire before the intervention and 2 months after the intervention.
Category
Lifestyle

2

Description
Control group: The control group will not receive any intervention and will complete the job stress questionnaire before the intervention and the resilience and burnout questionnaire before the intervention and 2 months after the intervention in the intervention group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza (AS) Hospital Complex in Kermanshah
Full name of responsible person
Dr. Shahram Bidhendi
Street address
Sorkheh Lijeh, Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6301
Email
irhk@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Mohamad Javan
Street address
Jalal Al Ahmad, Shahid Chamran Highway, Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 0000
Email
edu@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares university
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
Tarbiat Modares University
Full name of responsible person
Mojgan Rostami
Position
MSc Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Jalal Al-Ahmad, Shahid Chamran Highway, Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4875
Email
mo.rostami1400@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Afsaneh Sadooghiasl
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jalal Al-Ahmad, Shahid Chamran Highway, Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4875
Email
a.sadooghi@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Afsaneh Sadooghiasl
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jalal Al-Ahmad, Shahid Chamran Highway, Modares University
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4875
Email
a.sadooghi@modarse.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data will be published in groups without identification code
When the data will become available and for how long
After the decision of the journal to accept and publish the results in the form of an article is final
To whom data/document is available
Editors of scientific journals
Under which criteria data/document could be used
No new data analysis is allowed and can only be used to inform or check the scientific quality and accuracy of the study.
From where data/document is obtainable
Afsaneh Sadooghiasl
What processes are involved for a request to access data/document
After receiving a request from the editor of the magazine, during a meeting, they will decide which part of the information they can publish, and after deleting any identification code, the desired data will be sent by email or fax.
Comments
Loading...