Protocol summary

Study aim
Determining and comparing the impact of Balint method group therapy on job burnout and empathy with patients in the nurses of the oncology department of Shahid Sadougi Hospital
Design
A clinical trial with a control group with randomized parallel groups will be conducted using the permutation block randomization method.
Settings and conduct
This study will be conducted in the oncology department of Shahid Sadoughi Hospital in Yazd.
Participants/Inclusion and exclusion criteria
Entry criteria: 1- Working in the oncology department 2- Consent to participate in the study 3- Working experience of less than 20 years Exit criteria: 1. Having an active addiction to drugs or alcohol 2. Suffering from chronic physical disorders 3. Having psychotic disorders 4. The presence of psychological or drug interventions at the moment
Intervention groups
6 sessions of Balint group work will be conducted for the intervention group and 6 sessions of psychoeducation for the control group .Psychoeducation is about the types of bereavement, stages of bereavement and stress control.
Main outcome variables
Job burnout; empathy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230626058593N1
Registration date: 2023-08-07, 1402/05/16
Registration timing: registered_while_recruiting

Last update: 2023-08-07, 1402/05/16
Update count: 0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Nafiseh Alsadat Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 435 9481
Email address
nmousavi70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and comparing the effect of Balint group work on job burnout and empathy with patient in the nurses of the oncology department of Shahid Sadoughi Hospital in Yazd with the control group
Public title
The effect of Balint group work on empathy and job burnout
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Working in the oncology department Consent to participate in the study Work experience less than 20 years
Exclusion criteria:
Having an active addiction to drugs or alcohol Suffering from chronic physical disorders Having psychotic disorders The presence of psychological or drug interventions at the moment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are placed in one of the intervention and control groups using the permutation block randomization method. The selection of samples using the method of randomization of samples is based on the form of alternating blocks. Given that the total number of samples is 28, 7 blocks of size 4 will be considered and the blocks will be selected randomly. and then according to each block that contains 4 samples, the samples will be randomly assigned to one of the two intervention or control groups.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shohadaye Gomnam Blvd.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.020

Health conditions studied

1

Description of health condition studied
Examining job burnout and empathy with patients on nurses.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Job burnout
Timepoint
At the beginning of the study ( before the intervention) and at the end of the work
Method of measurement
Mezlach's burnout questionnaire (severity scale)

2

Description
Empathy with patients.
Timepoint
At the beginning of the study ( before the intervention ) and at the end of the work
Method of measurement
Jefferson's empathy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Balint Group .Balint group is a group intervention for the staff working in the medical science system. This intervention was designed and implemented by Professor Balint in 1957 and has been implemented around the world since then. The method of this intervention is in the form of a group in such a way that 12-14 members of the medical staff who have been selected homogeneously (have the same job) come together for 60 minutes with the presence of two group leaders in a group structure. The arrangement of the group is in the form of a ring. First, for 10 minutes, under the guidance of the leader and chosen by the group members, one person talks about his emotional experience in the work environment, especially in relation to the patient, then that person is removed from the group for 35 minutes.(The person stays in the group space and outside the circle.) And the rest of the group members talk about this person's emotional experience in an empathetic way, focusing on their own experiences. The leader directs the atmosphere of the group in order to better understanding the expressed experience and regulate people's emotions and empathy and performs the necessary interventions to reduce the emotional burden of the topic of discussion. Then, in the last 15 minutes, the first person enters the group and expresses his feelings and experience from listening to the talks of others and the group leaders, and the group leader analyzes the psychodynamic components of the relationship with the patient.
Category
Other

2

Description
Control group: Psychoeducation group: For this group, 6 sessions of psychoeducation will be held in such a way that each session will last for 60 minutes. The people of this group will be trained in psychological issues related to grief in the form of attending a training class. Sessions include: The first session talks about the definition of grief. The second session is about types of mourning. The third session is about the stages of mourning from the perspective of Kubler-Ross. The fourth session is about therapeutic and psychological interventions in bereavement. The fifth session is about stress control. The sixth session will be about emotion regulation.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital,Yazd
Full name of responsible person
Dr. Hussain Soleimani
Street address
Shahid Sadoughi Hospital, Ibn Sina Blvd.
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
sadoghi-hospital@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi
Street address
Yazd University of Medical Sciences, Shahid Sadoughi Blvd., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Shahabali Shirkhoda
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatric Center of Yazd, Shahid Beheshti Blvd., Taft
City
Yazd
Province
Yazd
Postal code
8991683316
Phone
009832632003
Email
shshirkhoda@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Shahabali Shirkhoda
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatric Center of Yazd, Shahid Beheshti Blvd., Taft
City
Taft
Province
Yazd
Postal code
8991683316
Phone
+98 35 3263 2003
Email
shshirkhoda@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nafiseh Alsadat Mousavi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Yazd University of Medical Sciences, Shahid Sadoughi Blvd., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916987200
Phone
+98 35 3728 4283
Email
nmousavi70@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
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 about the data that is related to the conclusion is published.
When the data will become available and for how long
After the study is completed and the result of the study is determined, it will be available
To whom data/document is available
All people interested in studying
Under which criteria data/document could be used
The use of data is allowed under the condition of compliance with ethics.
From where data/document is obtainable
Dr shirkhoda shshirkhoda@gmail.com
What processes are involved for a request to access data/document
The request should be submitted and the answer will be given after seeing the email.
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