Protocol summary

Summary
purpose:This study purposely conducts to investigate the role of health volunteers in training women regarding coping with stress strategies using self-efficacy theory. Planning: In this study,82 health volunteers and 820 under coverage women in 9 centers from 75 urban hygiene centers in Shiraz will attend based on purposive sampling. Setting and conduct: At first, an educational workshop will be held for the health volunteers through three 3-hour sessions. Then, the health volunteers will be asked to train the women regarding coping with stress strategies. major Inclusion and Exclusion criteria: Inclusion criteria of Volunteers: Being active volunteers; Volunteers satisfaction; to have diploma(Minimum education level); not suffering from psychological diseases under psychiatric treatment based on self-reported Exclusion criteria of Volunteers:Unwillingness of volunteers to keep working during the study period Inclusion criteria of women:women satisfaction. Exclusion criteria of women: unwillingness of women to keep working during the study period Intervention: The intervention will be in educational form that educational workshop, educational manuals and educational pamphlets related to stress and coping with stress strategies will be used together. main outcome measures (variables): Coping with stress; Coping Self-efficacy; Knowledge of stress

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201502016261N6
Registration date: 2016-09-22, 1395/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-22, 1395/07/01
Registrant information
Name
Mohammad Hussein Kaveh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
kaveh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Volunteers role in teaching women about stress coping strategies; an empowerment program using self-efficacy theory
Public title
Training coping strategies using self-efficacy theory by health volunteers in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria of Volunteers: Being active volunteers;volunteers satisfaction; to have a diploma(Minimum literacy level); not suffering from psychological diseases under psychiatric treatment based on self-reported Exclusion criteria of Volunteers:unwillingness of volunteers to keep working during the study period Inclusion criteria of women: women satisfaction. Exclusion criteria of women: Unwillingness of women to keep working during the study period
Age
From 17 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 902
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Placement of each center in each group, using obverse and reverse

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
93/429391

Health conditions studied

1

Description of health condition studied
stress
ICD-10 code
F40, F41,
ICD-10 code description
Neurotic, stress-related and somatoform disorders

Primary outcomes

1

Description
knowledge of stress in volunteers
Timepoint
Pre-test before training And post-test after 3-7 days of training
Method of measurement
stress knowledge of questionnaire

2

Description
Coping strategies with stress in volunteers
Timepoint
Pre-test before training And post-test after 3-7 days of training
Method of measurement
Endler & Parker coping strategies questionnaire

3

Description
self-efficacy in volunteers
Timepoint
Pre-test before training And post-test after 3-7 days of training
Method of measurement
coping self-efficacy scale

Secondary outcomes

1

Description
Knowledge of stress in women
Timepoint
Pre-test before training and post-Test after a month of training
Method of measurement
The difference between pre-test and post-test data

2

Description
Coping strategies with stress in volunteers
Timepoint
Pre-test before training and post-Test after a month of training
Method of measurement
Endler & Parker coping strategies questionnaire

3

Description
self-efficacy in women
Timepoint
Pre-test before training and post-Test after a month of training
Method of measurement
coping self-efficacy scale

Intervention groups

1

Description
Control group: The control group will not receive any intervention
Category
Prevention

2

Description
Intervention group: At first, an educational workshop will be held for the health volunteers through three 3-hour sessions. Then, the health volunteers will be asked to train the women regarding coping with stress strategies. the volunteer's and women's knowledge level will be assessed using a written test with Cronbach alpha of 64%.perceived skills related to coping with stress strategies and their self-efficacy also will be measured using coping inventory for stressful situations by Endler and Parker and Chesney Coping Self-efficacy Scale respectively
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Enghelab Health Center
Full name of responsible person
Moslem Rokhbin
Street address
Boulevard Sibawayh, Shiraz
City
Shiraz

2

Recruitment center
Name of recruitment center
Health Center Valfajr
Full name of responsible person
Moslem Rokhbin
Street address
contour of Safa Garden bridge and Hor bridge, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Poust Frosh
Street address
Shiraz University of Medical Sciences, Zand Boulevard, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hafez Hospital
Full name of responsible person
Doctor Alavi Shushtarî
Position
Psychiatrist
Other areas of specialty/work
Street address
Chamran Boulevard, Shiraz
City
Shiraz
Postal code
71946-34786
Phone
+98 71362715316
Fax
Email
hafezhospt@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health
Full name of responsible person
Doctor Mohamed Hussein Kaveh
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Health, Razi Boulevard, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
schealth@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Health
Full name of responsible person
Doctor Mohamad Hussein Kaveh
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Health, Razi Boulevard, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
schealth@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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