Protocol summary

Study aim
The Effectiveness of Cognitive-Behavioral Therapy on the Job Stress of Midwives in the Labor Department
Design
Clinical trial with control group, randomized with quadruple blocks, the sample size was considered as 40.
Settings and conduct
The sampling sites are the obstetrics departments of Haji Narges moarafe and Tamin Ejtemaee hospitals. The researcher visits these sections and invites people to participate in the research. A briefing is to be held and after obtaining written consent and ensuring confidentiality of Information, the job stress questionnaire is completed by people who have the criteria for entering the study. Meetings are held in the classroom located in the Department obstetrics Haji Narges moarafe and tamin ejtemaee Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1 - Informed consent to participate in the study. 2 - Earning a score above 117 from the job stress questionnaire. 3 - Having at least a midwifery diploma. Exit criteria: 1 - Cognitive-behavioral therapy and any psychological intervention with in the last 12 weeks. 2 - A history of chronic medical and psychological illnesses. 3 - The use of psychoactive drugs. 4 - The experience of an unfortunate incident, such as the death of a first-degree relative, in the past six months.
Intervention groups
For the intervention group, 8 group counseling sessions will be held using the cognitive- behavioral therapy method. After the research, the control group will receive 2 intensive counseling sessions.
Main outcome variables
Job stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190212042682N1
Registration date: 2019-03-08, 1397/12/17
Registration timing: prospective

Last update: 2019-03-08, 1397/12/17
Update count: 0
Registration date
2019-03-08, 1397/12/17
Registrant information
Name
Fatemeh Karaminejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3312 3251
Email address
karaminejad.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-05-04, 1398/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Cognitive-Behavioral Therapy on the Job Stress of Midwives in the Labor Department
Public title
The Effectiveness of Cognitive Behavioral Therapy on Midwives' Job Stress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study. Earning a score above 117 from the job stress questionnaire. Having at least a midwifery diploma.
Exclusion criteria:
Cognitive-behavioral therapy and any psychological intervention with in the last 12 weeks. A history of chronic medical and psychological illnesses. The use of psychoactive drugs. The experience of an unfortunate incident, such as the death of a first-degree relative, in the past six months.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning people to the control and test groups is randomized and quadruple blocks(Using the table for random permutations). After determining the block size in this study, the block list is provided and the number assigned to them, then random numbers will be chosen between 1 and 6. AABB(1), ABAB(2), ABBA(3), BBAA(4), BABA(5), BAAB(6)
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-01-25, 1397/11/05
Ethics committee reference number
IR.AJUMS.REC.1397.803

Health conditions studied

1

Description of health condition studied
Job stress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Job stress score based on Rice questionnaire
Timepoint
Job stress measurement before and after the intervention immediately after the end of the study (8 sessions) and one month after the completion of the study.
Method of measurement
Rice Job Stress Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, 8 group meeting sessions of 10 persons are conducted on a weekly 90-minute basis by consulting a Cognitive-behavioral therapy methodology researcher and supervised by an advisor in the classroom located in the obstetrics Departments of Haji Narges moarafe and tamin ejtemaee hospitals.
Category
Treatment - Other

2

Description
Control group:After the research, the control group will receive 2 intensive counseling sessions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Haji Narges moarafe Hospital and tamin ejtemaee hospitals.
Full name of responsible person
Khadija Hekmat
Street address
Shahid Motahari Street.,Hajia Narges Hospital ., tamin ejtemaee hospital.
City
Mahshahr Port
Province
Khouzestan
Postal code
6353141319
Phone
+98 61 5233 5025
Fax
Email
hekmat1346@Gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Ahvaz Jundishapur University of Medical Science., Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
Fax
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Khadija Hekmat
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613311159
Email
hekmat1346@Gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Khadija Hekmat
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6335715794
Phone
+98 33 11159
Email
Hekmat1346@Gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Karaminejad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 14, The houses of sada and sima
City
Bandar Mahshahr
Province
Khouzestan
Postal code
6353141319
Phone
+98 61 3312 3251
Email
karaminejad.f1357@jmail.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
The whole potential data is unpublished after being unidentifiable
When the data will become available and for how long
Data will be available after publication and available for a one-year period.
To whom data/document is available
Only for scholars working in scientific institutions.
Under which criteria data/document could be used
The data are available with reference to the name of the investigator and clinical trials and research.
From where data/document is obtainable
Ms. Khadijeh Hekmat, Faculty Member of Ahvaz Jundishapur University of Medical Sciences Email address: hekmat1346@Gmail.com
What processes are involved for a request to access data/document
Send the request via email will be answered as soon as possible.
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