Protocol summary

Study aim
Modifying the educational programs of medical residents by eliminating the post night shifts activity for female medical residents and examining its impact on job burnout and its relationship with psychological variables.
Design
This semi-experimental study is of a pre-and post-type design, With sample size of 29 selected by available sampling method
Settings and conduct
This semi-experimental study is of a pre-and post-type design, focusing on medical residents in the field of obstetrics and gynecology across four levels (first year to fourth year) at the educational hospital (Shariati Hospital). The sample size consists of 29 female medical residents, selected using convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gynecology and obstetrics residents currently practicing at Shariati Hospital. Exclusion criteria: 1- lack of consent to enter the study and answer the questionnaires 2- Assistants with a history of taking neuropsychiatric drugs and a history of underlying diseases
Intervention groups
This semi-experimental study is of a pre-and post-type design, focusing on medical residents in the field of obstetrics and gynecology at the educational-treatment center of Tehran University of Medical Sciences (Shariati Hospital). Coordination will be made to implement a work schedule that eliminates on-post night shift activities for the residents and allows for a 24-hour rest period. Before eliminating the on-call shift schedule, questionnaires will be distributed to the residents, and they will be asked to carefully complete them. Then, after removing the on-call shift schedule and continuing this method for two months, the residents will complete the questionnaires again.
Main outcome variables
burnout (based on a valid 22-question questionnaire); Psychological variables (stress, anxiety and depression) based on the 21-question DASS questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240521061857N1
Registration date: 2024-06-19, 1403/03/30
Registration timing: registered_while_recruiting

Last update: 2024-06-19, 1403/03/30
Update count: 0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Mohadese Dashtkoohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 982 0354
Email address
m-dashtkoohi@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-15, 1403/03/26
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of job burnout before and after the elimination of post-shift activity and its relationship with psychological variables in the assistants of Tehran University of Medical Sciences (Shariati Hospital)
Public title
burnout before and after the elimination of post-shift activity
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
obstetrics and gynecology Medical residents
Exclusion criteria:
Failure to provide consent to participate in the study Residents with a history of taking neuropsychiatric drugs or a history of underlying diseases.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 29
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
A semi-experimental study of before-after type

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
تهران
Province
Tehran
Postal code
14117-13135
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1403.029

Health conditions studied

1

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

Primary outcomes

1

Description
burn-out
Timepoint
before and after two months from the intervention
Method of measurement
Burn-out questionnaire that has 22 items by Christian Masserledge and Susan X. Jackson with the aim of evaluating the individual's experience of burnout. It has been validated in iran.

Secondary outcomes

1

Description
Psychological state
Timepoint
قبل از مداخله و دو ماه بعد از مداخله
Method of measurement
DASS-21 questionnaire

Intervention groups

1

Description
Intervention group: Intervention Group: This is a quasi-experimental study of the before-and-after type, with the statistical population consisting of gynecology medical residents in 4 year levels at the educational and medical center of Tehran University of Medical Sciences (Shariati Hospital). The sample size is 29 gynecology medical residents across 4 residency levels, selected through convenience sampling. After obtaining ethical approval and university permissions, coordination will be made with the head of the gynecology department in the educational hospitals of Tehran University of Medical Sciences to implement a work schedule eliminating on-call shifts for gynecology residents, allowing for a 24-hour rest period following night shifts. Before removing the on-call schedule, questionnaires will be distributed to the residents, who will be asked to carefully complete them. After the removal of the on-call shifts and the continuation of this method for two months, the questionnaires will be completed by the residents again. Residents will be asked to add the last three digits of their national ID to the last two digits of their home number and write it down as the questionnaire code. The tools include validated burnout questionnaires, the DASS-21 questionnaire, and a demographic questionnaire. The demographic questionnaire includes age, marital status, number of children, place of residence, residency year, number of on-call nights per month, number of working hours per week, medical experience, years of work experience, and primary workplace (academic or clinical). Inclusion criteria: All gynecology residents from the first to the fourth year stationed at Shariati Hospital.Exclusion criteria: Lack of consent to participate in the study, failure to complete the questionnaires, history of psychiatric medication use, and history of underlying diseases.Outcomes to be monitored: Job burnout (based on a validated 22-item questionnaire) and psychological variables (stress, anxiety, and depression) based on the 21-item DASS-21 questionnaire.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Aida Najafian
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
14117-13135
Phone
+98 21 8490 2635
Email
aidanajafian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Sari
Street address
Tehran University of Medical Sciences, Keshavarz Boulevard,Tehran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
info@tums.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Aida Najafian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
14117-13135
Phone
+98 21 8822 0050
Email
aidanajafian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aida Najafian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
14117-13135
Phone
+98 21 8822 0050
Email
aidanajafian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aida Najafian
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kargar Shomali Ave, Shariati Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
14117-13135
Phone
+98 21 8822 0050
Email
aidanajafian@yahoo.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
No - There is not a plan to make this available
Title and more details about the data/document
The anonymized data of participants will be shared with the journal upon request from the corresponding author.
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
to perform meta-analysis
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
Upon request via Email from the corresponding author
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