Protocol summary
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Study aim
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This study is carried out with the aim of determining the effect of educational intervention based on self-efficacy model on stress management in Ramhormoz health and treatment network employees.
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Design
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A controlled, single-blind, randomized clinical trial of 94 employees. PASS statistical software was used for randomization.
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Settings and conduct
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This study is a randomized controlled trial, using the pre-test-post-test method. Shahrram-Hormoz has 2 comprehensive urban health centers, 4 urban bases, 4 rural centers and 4 rural urban centers. From among the centers, we will have a sample of urban centers, rural centers, and health centers in the control and intervention groups. Also, among Behorzi School - Health Network, and the headquarters of the health center, one case will be randomly in the observation group and one case in the group. intervention will take place.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Not taking psychoactive drugs based on the person's self-declaration.
Living in Ramhormoz
Willingness to participate in the study and complete the informed consent form.
Exclusion criteria:
Experiencing traumatic events during the intervention based on verbal questions by the interviewer
Change of residence outside the research environment.
Absence of more than 2 sessions in training sessions.
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Intervention groups
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In this study, 8 sessions of 45 minutes will be held with interactive lecture method, group discussion and also media such as slide show in the form of PowerPoint program, clip show.During this period, the control group will not receive any intervention.
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Main outcome variables
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Stress management skills
General information
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Reason for update
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The problems have been solved.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230917059445N1
Registration date:
2023-09-26, 1402/07/04
Registration timing:
retrospective
Last update:
2023-12-02, 1402/09/11
Update count:
1
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Registration date
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2023-09-26, 1402/07/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-08-23, 1402/06/01
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Expected recruitment end date
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2023-09-23, 1402/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of educational intervention based on the self-efficacy model on stress management in Ramhormoz health care network staff .
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Public title
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The effect of educational intervention based on the self-efficacy model on stress management in Ramhormoz health care network staff .
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Not taking psychoactive drugs based on the person's self-declaration.
Living in Ramhormoz (no change of residence outside the research environment from the beginning of the study to the end of the study)
Willingness to participate in the study and complete the informed consent form
Exclusion criteria:
Experiencing traumatic events during the intervention based on verbal questions by the interviewer
Change of residence outside the research environment.
Absence of more than 2 sessions in training sessions.
Unwillingness to continue attending the study
Not completing the pre- or post-test completely
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
97
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Cluster sampling to select health centers, then random sampling to select one health center as the control group and one health center as the intervention group.
Ramhormoz city has 2 comprehensive urban health centers, 4 urban centers, 4 rural centers and 4 rural urban centers.
Among the health centers of the city, one urban health center, two urban bases, 2 rural centers and 2 rural urban centers are randomly selected for educational intervention.
Also, one case will be randomly placed in the observation group and one case will be placed in the intervention group from Behorzi School and the Health Center Headquarters.
Randomization was simple with equal blocks, with the help of PASS statistical software
How to make a random sequence: based on the PASS software random number table
It was one-sided blind, which means that only the subjects did not know which group they were in.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Training sessions are held for the intervention group.
The control group is provided with an educational pamphlet.
The researcher is fully aware of the allocation of people.
The person responsible for collecting data and the analyst is also a researcher.
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-03-05, 1401/12/14
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Ethics committee reference number
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شناسه IR.Sums.Scheanut.Rec.1401.141
Health conditions studied
1
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Description of health condition studied
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Job stress
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Stress management
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Timepoint
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The beginning and end of the study
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Method of measurement
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Occupational stress questionnaire, self-efficacy questionnaire, Lazarus coping skills questionnaire
Secondary outcomes
1
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Description
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Efficacy
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Timepoint
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The beginning and end of the intervention
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Method of measurement
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Self-efficacy questionnaire
Intervention groups
1
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Description
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Intervention group: Receive 8 training sessions for two months, receiving pamphlets and educational clips.
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Category
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Lifestyle
2
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Description
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Control group: Get the educational pamphlet
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available