Determining the Impact of Theoretical Intervention on Health Promotion in the Workplace in Stress Control
Design
A clinical trial with control and intervention group, parallel groups, Without blinding, simple accident.
Settings and conduct
The study population is health workers working in health centers in Qazvin province. The results are collected before and after and three months later and 6 months after training and organizational changes with the help of a questionnaire.
Participants/Inclusion and exclusion criteria
1. Official, contractual and corporate employees working as health care providers
2. Have at least 6 months of work experience as a health care provider
3. Do not use certain sedatives
4. Lack of specific diseases
Intervention groups
For the intervention group, 3 workshops will be held for two hours a week for 3 weeks. Group discussion sessions and daily practice reports will be held on virtual social networks during the intervention. Organizational changes are also applied to support. In the control group, no intervention is performed except for routine programs. The study questionnaire is completed in before, immediately after the intervention, 3 months later and six months later by the participants to measure the amount of stress.
Main outcome variables
Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045322N1
Registration date:2020-04-06, 1399/01/18
Registration timing:prospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Masoumeh Zeinolabedini
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0129
Email address
m.zeinolabedini@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of theory-based health promotion in the workplace to control stress in health care workers
Public title
Investigating the effect of theoretical intervention on health promotion in the workplace in controlling employee stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Official, contractual and corporate employees working as health care providers in comprehensive health care centers
Have at least 6 months of work experience as a health care worker
Exclusion criteria:
Existence of any factors that make it difficult for employees to participate.
Age
To 45 months old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A simple coincidence, in this method, from the list of 6 cities of Qazvin province, each of which is covered by a health network, 2 cities are randomly selected, then the eligible people are registered and Finally, by lottery, one of the two cities will enter the control group and the other will enter the intervention group.
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 Tarbiat Modares University
Street address
Nasr, Jalal Al-Ahmad,Tehran
City
Tehran
Province
Tehran
Postal code
141173116
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.MODARES.REC.1397.032
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of stress in employees
Timepoint
The study questionnaire is completed by the participants 3 months in advance and six months immediately after the intervention.
Method of measurement
Using a researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Educational and organizational intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Health Department
Full name of responsible person
Masoumeh Zeinolabedini
Street address
Next to Mofteh Street.Azadegan Boulevard. Qazvin
City
Qazvin
Province
Qazvin
Postal code
34148-53135
Phone
+98 28 3368 6201
Fax
+98 28 3367 0034
Email
health@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares Modares University
Full name of responsible person
Dr. Yaqub Fathollahi
Street address
Nasr Bridge, Jalal AleAhmad Highway,Tehran
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4506
Email
hidarnia@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Medical Sciences, Tarbiat Modares Modares University
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
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Alireza Heidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Nasr Bridge, Jalal AleAhmad Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4506
Email
hidarnia@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Alireza Heidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Nasr Bridge, Jalal AleAhmad Highway,Tehran
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4506
Email
hidarnia@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Alireza Heidarnia
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Nasr Bridge, Jalal AleAhmad Highway,Tehran
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4506
Email
hidarnia@modares.ac.ir
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
Demographic information is confidential, but information about research outcomes can be shared.
When the data will become available and for how long
One week after receiving the email request to the principal in charge of the study
To whom data/document is available
Researchers at scientific and academic institutions, Ministry of Health
Under which criteria data/document could be used
Health Departments of Medical Sciences Universities
From where data/document is obtainable
Dr. Heidarnia, Chief Research Officer
Email:hidarnia@modares.ac.ir
What processes are involved for a request to access data/document
One week after receiving the email request to the principal in charge of the study