Protocol summary

Study aim
1.Effectiveness of emotion regulation training on the compassion fatigue of nurses. 2.Effectiveness of emotion regulation training on the burnout of nurses.
Design
Controlled clinical trial. At first, people announced their willingness to participate in the project. Subjects were randomly assigned to draw two groups of intervention and control. The sample size was 60 and in each group was 30.
Settings and conduct
This clinical trial was conducted at Alzahra Hospital in Isfahan in 2018. 60 intensive and critical care nurses (8.3% male) were randomly divided into two groups experimental (n = 30) and control (n = 30). The experimental group received 6 sessions of emotion regulation training, while the control group did not receive any interventions. Professional quality of life questionnaire and cognitive emotion regulation questionnaires were completed by both groups before and after the intervention. Data were analyzed by descriptive and inferential statistics in SPSS-22 software.
Participants/Inclusion and exclusion criteria
inclusion criteria: Conscious willingness and agreement to participate in the research project, occupation in intensive and critical care units, no history of using antidepressants and anti-anxiety drugs on the based on self-report, lack of experience in teaching emotion regulation training, non-use of psychotropic drugs or substance abuse at the moment based on the self-report exclusion criteria: Absence of more than two sessions in the training program and exposure to severe stressful events during the study
Intervention groups
1. Experimental group: received 6 sessions of emotion regulation training. 2. Control group: No intervention
Main outcome variables
1. Burnout 2. Compassion fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171005036572N3
Registration date: 2018-10-15, 1397/07/23
Registration timing: retrospective

Last update: 2018-10-15, 1397/07/23
Update count: 0
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Hamid Kharatzadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
h_kharatzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-26, 1397/04/05
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
2018-07-01, 1397/04/10
Actual recruitment end date
2018-07-13, 1397/04/22
Trial completion date
2018-09-01, 1397/06/10
Scientific title
Effectiveness of emotion regulation training on compassion fatigue and burnout of intensive and critical care nurses as compared to control group
Public title
Effectiveness of emotion regulation training on compassion fatigue and burnout of intensive and critical care nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious willingness and agreement to participate in the research project Occupation in intensive and critical care units No history of receiving emotion regulation training No history of taking antidepressants and anxiolytics based on self-reported Non-use of psychotropic drugs or substance abuse currently based on self-declaration
Exclusion criteria:
Missing more than two sessions in the training program Exposure to severe stressful events during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, people were selected voluntarily and then assigned to one of the two intervention or control groups using the lottery.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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 jerib St. Isfahan city
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
IRMUI.REC.1396.2.087

Health conditions studied

1

Description of health condition studied
Burnout
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Burnout: is a psychological syndrome due to repeated and prolonged exposure to occupational stress and work-pressure.
Timepoint
1. pretest & 2. posttest
Method of measurement
Professional quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group received an emotion regulation training course. In this research, emotion regulation training is a 6-session curriculum, and its main components include emotional training, changing emotional excitement, changing attention, changing cognitive assessments and changing the behavioral and physiological outcomes of excitement.
Category
Behavior

2

Description
Control group: The control group did not receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hasan Rezvani
Street address
Sofeh Blve. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir/fa/
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
Shahed University
Full name of responsible person
Hamid Kharatzadeh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahed University, Khalij Fars highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
hkharratzade@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Hamid Kharatzadeh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khalij Fars highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
hkharratzade@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Hamid Khaatzadeh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khalij Fars highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
hkharratzade@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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