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Comparing the effectiveness of Balint group work and compassion focus group therapy on quality of life, burnout and psychosomatic syndrome in emergency department's nurses, Kowsar hospital, Semnan, 2022

Protocol summary

Study aim
This study aims to compare the effectiveness of two methods of group therapy on quality of life, burnout, and psychosomatic symptoms
Design
In a randomized, controlled clinical trial, phase 3 with pre and post-test, 33 nurses working in the emergency department are randomly assigned to three groups. For randomization, first 39 balls from number 1 to 39 are considered and then randomly divided into three equal groups, including group 1 (Balint), group 2 (compassion therapy) and group 3 (control) and then using a lottery container, the ball of each group was taken out and the intended sequence was recorded.
Settings and conduct
Nurses working in the emergency department in Semnan, will be assigned to intervention or control groups. Questionnaires for quality of life, Maslach burnout and psychosomatic criteria are filled and compared before and after intervention.
Participants/Inclusion and exclusion criteria
Nurses working in the emergency department with at least three years of experience will be enrolled in the study. Nurses who have a second job, with a physical or mental illness, or receive any psychotherapy are excluded.
Intervention groups
In the pre-test stage, quality of life, burnout and DCPR questionnaires are completed. For the first group, weekly Balint sessions are held for 8 weeks. The second group attended 8 weekly sessions of a group-based compassion-focused therapy approach and the control group completed the pre and post-test without any intervention, but waiting according to ethical principles. Finally, after three months, the questionnaires are refilled as post test and the scores are compared by pre-test scores.
Main outcome variables
Quality of life; burnout; psychosomatic symptoms.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151020024625N15
Registration date: 2022-04-30, 1401/02/10
Registration timing: prospective

Last update: 2022-04-30, 1401/02/10
Update count: 0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Balint group work and compassion focus group therapy on quality of life, burnout and psychosomatic syndrome in emergency department's nurses, Kowsar hospital, Semnan, 2022
Public title
Effectiveness of Balint group work and compassion focus group therapy on quality of life, burnout and psychosomatic syndrome in emergency department's nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
َJob exprience at least 3 years Nurses working in the emergency department
Exclusion criteria:
Having a second job Physical or mental illness Receiving any type of psychotherapy
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 39
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, at first stage, 39 spheres from one to 39 are considered and following that will randomly assigned into three groups, including "1" (Intervention, Balint group) and group 2 (Intervention, compassion focus group) and group 3 (Control group), in this way, the first ball is assigned to the first group (Intervention, Balint group), the second ball to the second group (Intervention, compassion focus group) and the third ball to the third group (Control group), and the process is repeated and the intended sequence will be recorded.
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 Medical Faculty, Mashhad University of Medical Sciences
Street address
Azadi Square, Easter Enterance of Pardis
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2021-06-26, 1400/04/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.196

Health conditions studied

1

Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Burnout
ICD-10 code
Z73.0
ICD-10 code description
Burn-out

3

Description of health condition studied
Psychosomatic disorders
ICD-10 code
F45
ICD-10 code description
Somatoform disorders

Primary outcomes

1

Description
Quality of life
Timepoint
8 Weeks after intervention
Method of measurement
The World Health Organization's Quality of Life Questionnaire (WHOQOL-Bref)

2

Description
Burn-out
Timepoint
8 Weeks after intervention
Method of measurement
Maslach Burnout Inventory

3

Description
Psychosomatic disorder
Timepoint
8 Weeks after intervention
Method of measurement
Diagnostic Criteria for Psychosomatic Research (DCPR)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the first group, weekly Balint sessions are held for 8 weeks. Each session is 60-90 minutes. The group's leader is researcher and is the only one who can indirectly offer solutions and suggestions. In each session, participants expresses an emotional traumatic events which they was experienced, put them at a crossroads, or have a mental repetition. A topic is selected from the topics and the narrator is asked to describe the situation and feelings at that time and the present moment. The members of the group are completely silent as long as the narrator speaks. After the narrator has spoken, he is asked to leave the group and sit and watch. The leader then asks the group members to talk about bodily feelings or similar experiences without any judgment and to ask the narrator questions for more information, the narrator has the right to answer or not. Finally, the leader concludes and indirectly suggests solutions to the narrator.
Category
Behavior

2

Description
Intervention group: For the second group, weekly sessions compassion-focused group therapy are held for 8 weeks. The first session includes initial communication, pre-test, general principles of compassion therapy and distinguishing regret from compassion, conceptualizing of self-compassion education. The second session is mindfulness training along with physical examination and breathing exercises,being familiar with brain systems based on compassion, empathy training, training to make people understand that they feel they can handle the situation with a sympathetic attitude. The third session is Becoming familiar with the characteristics of people with compassion, feeling compassion for others, cultivating the feelings of warmth and kindness to oneself, developing the understanding that others also have flaws and problemsin the face of self-destructive feelings and shame (cultivating a sense of human commonalities), teaching empathy. Forth session: encouraging the subjects to self-knowledge and examine their personality according to educational topics; identifying oneself as a non-compassionate or compassionate person;identifying oneself as a person who values self-compassion, empathy and sympathy;developing a compassionate mind;applying exercises to oneself and others; teaching the physiotherapist metaphor, teaching forgiveness. Fifth session:Performing compassionate mind developing exercises; reviewing the previous session; being familiar and applying forgiveness, acceptance without judgment, teaching the metaphor of the flu, and teaching patience; teaching acceptance of issues; accepting the changes ahead; enduring difficult and challenging situations considering the changing nature of life and confronting with different challenges. Sixth session: creating compassionate images practically, teaching styles and methods of expressing compassion (verbal compassion, practical compassion, intermittent compassion, and continuous compassion); applying these methods in daily life and for spouse, children, parents, friends, teachers, and acquaintances; teaching the developing valuable and transcendent emotions. Seventh session: teaching writing compassionate letters for oneself and others, teaching dailyregistering and recording real situations based on compassion and individual's performance in applying this method in that situation. Eighth session: Training and practicing skills, reviewing and practicing the skills presented in previous sessions forhelping subjects to confront different situation in different ways; final summarizing, and providing solutions to maintain and apply this therapeutic method in everyday life.
Category
Behavior

3

Description
Control group: The control group will participate in pre-test and post-test and will not receive any intervention during the research. But, based on ethical issues, control group are placed on a waiting list for training, and after conducting research and obtaining results, a method that is more effective will be implemented on them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Educational, Research and Treatment Center
Full name of responsible person
Roza Salehian
Street address
Basidj Boulevard, Amin Avenue
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
dr.roza.salehian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Meshkat
Street address
Vice Chancellor for Research and Technology, School of Medicine, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2109
Email
MeshkatZ@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Roza Salehian
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
dr.roza.salehian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roza Salehian
Position
Postdoctoral researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
dr.roza.salehian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchman
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Amin Ave, Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
mehrdadzahmatkesh@semums.ac.ir

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 further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Anonymized data will be offered.
When the data will become available and for how long
After publishing of final report
To whom data/document is available
rcher who working in academic institutions
Under which criteria data/document could be used
Referees and competent people
From where data/document is obtainable
Contact with scientific responsible
What processes are involved for a request to access data/document
After verifying the applicant's position
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