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The Impact of Balint Group on Mental Health of Healthcare Workers in Covid-19 Pandemic

Protocol summary

Study aim
Determining the extent of mental distress,avoidance,unwanted thoughts,hyperactivity,depression and anxiety in health workers while serving in the Covid-19crisis
Design
The research is a before and after quasi-experimental.After receiving the code of ethics, a virtual invitation message will be sent to people. Individuals enter the project after the initial interview,then the purpose is explained,written consent,and then research and demographic questionnaires are answered. They will then join the intervention groups.At the end of the course, individuals will answer the questionnaires again and the results will be analyzed by dependent t test.
Settings and conduct
intervention will be via Skype with 9 members, a leader and an assistant leader in 75 minutes per session ,three times a week. The members of the group will be between 8-12 people. If members request an individual meeting, it will be provided to them by the leader or assistant leader. Participants are from all groups that serve patients with or suspected of having coronary heart disease or caregivers of suspected and suspected individuals.
Participants/Inclusion and exclusion criteria
Working in health centers,Having Covid 19 or encountering Covid-19 patients,having diploma or higher,age between 20-50,Having the consent to participate in research, Not using psychiatric drugs and psychological therapies during the study not suffering from other acute or chronic disorders, problem in hearing or speaking
Intervention groups
This intervention will be performed as Balint group on health care workers, including physicians,nurses,midwives,interns,residents and crew. under a safe psychoanalytic environment, members narrate and process cases under guidance of a psychoanalyst leader,rethink their work through a group discussion.
Main outcome variables
Mental helplessness, avoidance, Unwanted thoughts, Anxiety, Depression, hyper-arousal

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180502039508N2
Registration date: 2021-09-08, 1400/06/17
Registration timing: registered_while_recruiting

Last update: 2021-09-08, 1400/06/17
Update count: 0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
Maedeh Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3236 6790
Email address
parvizimaedeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Balint Group on Mental Health of Healthcare Workers in Covid-19 Pandemic
Public title
The effect of balint group on psychological symptoms of health care workers during corona
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Working in health centers Having Covid 19 or encountering Covid-19 patients having diploma or higher age between 20-50 Having the consent to participate in research
Exclusion criteria:
using psychiatric drugs and psychological therapies during the study suffering from other acute or chronic disorders problem in hearing or speaking
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 55
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
shahroud
Province
Semnan
Postal code
3614773955
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.SHMU.REC.1399.145

Health conditions studied

1

Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Anxiety score in GAD-7 questionnaire
Timepoint
Before and after the intervention
Method of measurement
GAD-7 questionnaire

2

Description
Patient Health Questionnaire 9-Scale score
Timepoint
Before and after the intervention
Method of measurement
Patient Health Questionnaire 9-Scale

3

Description
Impact of Event Scale - Revised score
Timepoint
Before and after the intervention
Method of measurement
Impact of Event Scale - Revised questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Healthcare Workers
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahroud University of Medical Sciences
Full name of responsible person
Maedeh Parvizi
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
parvizimaedeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud, Seventh Tir Square, Shahroud University of Medical Sciences and Health Services, Vice Chancellor for Research and Technology
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 6714
Email
vcr@shmu.ac.ir
Web page address
https://shmu.ac.ir/research/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Maedeh Parvizi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
parvizimaedeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maedeh Parvizi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahroud, Imam Hosein Hospital
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3236 6790
Fax
Email
parvizimaedeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maedeh Parvizi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 1609
Email
parvizimaedeh@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all the data is potentially shareable after unidentifying individuals.
When the data will become available and for how long
from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of published documents for scientific and therapeutic purposes is permitted after contacting the responsible author.
From where data/document is obtainable
parvizimaedeh@gmail.com
What processes are involved for a request to access data/document
After receiving the email and reviewing the application, the information will be provided to the applicant within a week.
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