The effectiveness of educational-treatment package based on psychological flexibility in burnout, quality of working life, work-family conflict and mental health of the care team working in medical centers for patients with COVID-19
Preparation of educational-therapeutic package based on psychological flexibility (based on acceptance) and evaluation of its effect on quality of work life, burnout and work-family conflict and mental health for the care team working in medical centers for patients with COVID-19
Design
A clinical trial with a control group, with one-way blind groups, randomized
Settings and conduct
This intervention is performed on the staff working in the corona care unit in a hospital unit on the intervention group.کار
Participants/Inclusion and exclusion criteria
Inclusion criteria
1- Working in medical centers for patients with COVID-19
2- Age between 23 and maximum 65 years;
3- Lack of physical and mental illness
Output Criteria:
1- Dissatisfaction with continuing research.
2- The occurrence of any serious accident or complication that prevents the continuation of the study.
Intervention groups
Implement an educational-therapeutic package based on psychological flexibility on the intervention group
And the control group will not intervene.
Main outcome variables
Quality of working life, burnout, work-family conflict, mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047052N1
Registration date:2020-05-07, 1399/02/18
Registration timing:registered_while_recruiting
Last update:2020-05-07, 1399/02/18
Update count:0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Sayed Mohammad Hosein Mosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3337 5680
Email address
hpsy97@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of educational-treatment package based on psychological flexibility in burnout, quality of working life, work-family conflict and mental health of the care team working in medical centers for patients with COVID-19
Public title
The effectiveness of educational-treatment package based on psychological flexibility in burnout, quality of working life, work-family conflict and mental health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Working in medical centers for patients with COVID-19
Age between 23 and maximum 65 years
Exclusion criteria:
Dissatisfaction with continuing research.
The occurrence of any serious accident or complication that prevents the study from continuing
Having a specific physical and psychological illness
Age
From 23 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, to allocate members to control and intervention groups, first a cluster of four sections of a section was selected and in the selected section based on simple randomization using statistical software, randomization to allocate members to the intervention group and Control is done.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, people such as the clinical caregiver, the outcome assessor, the data analyst, the data safety and monitoring committee, and the researcher are unaware of which group the participant is in.
Also, the selected participant in an intervention group learns about the implementation and duration of the intervention, but does not know the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.MUI.MED.REC.1399.026
Health conditions studied
1
Description of health condition studied
the care team working in COVID-19 patients
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Quality of work life score in Walton's questionnaire
Timepoint
Before and after the implementation of the educational-therapeutic package
Method of measurement
Walton's Work Quality of Life Questionnaire
2
Description
Mental Health Score in the General Health Questionnaire (GHQ)
Timepoint
Before and after the implementation of the educational-therapeutic package
Method of measurement
General Health Questionnaire (GHQ)
3
Description
Work-Family Conflict Score and Family-Work Conflict in the Work-Family Conflict Questionnaire
Timepoint
Before and after the implementation of the educational-therapeutic package
Method of measurement
the Work-Family Conflict Questionnaire
4
Description
The burnout score on the burnout questionnaire is gold
Timepoint
Before and after the implementation of the educational-therapeutic package
Method of measurement
Goldard's burnout questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention team will receive a training package based on psychologically developed flexibility for 8 two-hour sessions using educational facilities such as blackboards.This educational-therapeutic package is based on a qualitative research of the theoretical theory and has been prepared after interviewing and observing the treatment staff in the special sections of Corona and Codex based on psychological flexibility.
Category
Treatment - Other
2
Description
Control group: They will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid, Amin, Isa Ibn Maryam, Omid, Al-Zahra
Full name of responsible person
Amrolla Ebrahimi
Street address
Isfahan University of Medical Sciences, Faculty of Medicine
City
Esfaahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Fax
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Web page address
http://med.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard, Isfahan Medical Sciences Research and Technology Deputy
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Fax
+98 31 3668 8597
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amrullah Ebrahimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Associate Professor, Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Fax
+98 31 3668 8597
Email
a_ebrahimi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amrullah Ebrahimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Esfhan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3688 9313
Email
a_ebrahimi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amrullah Ebrahimi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Associate Professor, Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, School of Medicine
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Fax
+98 31 3668 8597
Email
a_ebrahimi@med.mui.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
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
Information on the main consequence
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Everyone
Under which criteria data/document could be used
Use for research and applied fields
From where data/document is obtainable
Send a request to seyedmhm74@gmail.com
What processes are involved for a request to access data/document