- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780633
PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors
February 28, 2021 updated by: Manolya Parlas, Ataturk University
The Effects of a PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors: A Randomized Controlled Trial
The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group.
The study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January 2018.
Of the women with genital infections, 120 women were included in the study, of which 60 were in the experimental group and 60 were in the control group.
The data were collected by "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire" and "Genital Hygiene Behavior Inventory".
In study, genital hygiene training intervention prepared according to the Precede-Proceed model was applied to the women in the experimental group.
The women in the experimental group were measured at three different times: pre-test before training, post-test through training completition, and follow-up test after 4 weeks.
The women in the control group did not receive any training intervention, the pre-test at the first encounter in the family health center and the post-test 5 weeks later.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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None Selected
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Izmir, None Selected, Turkey, 35210
- Manolya Parlas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Between the ages of 18-49,
- married,
- At least primary school graduate,
- No mental and communication problems,
- No chronic disease,
- Non-pregnant.
Exclusion Criteria:
- Women who have entered menopause,
- Women who had received any training on genital hygiene before
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Precede-Proceed based Training Program
The experimental group is the group in which five training sessions interventions are applied.
|
A Training Program for Genital Hygiene Behaviors prepared in line with the Precede-Proceed model was presented to the women in the experimental group.
The trainings started one week after the pre-test data were collected and were conducted in a total of 5 sessions, each lasting an average of 40 minutes, once a week.
At the end of the five-week training, a post-test was applied.
In order to determine the behavior changes of the women in the experimental group, a follow-up test was applied 4 weeks after the training ended.
At the end of the training, women were given a training booklet prepared by the researcher.
|
No Intervention: Control group
The control group is the group in which have no educational intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
H1 hypothesis: PRECEDE-PROCEED training-based program affects on improving genital hygiene behavior.
Time Frame: 5 weeks
|
Linear regression analysis was performed to determine the factors that are independently effective in determining the Genital Hygiene Behavior Inventory (GHBI) score differences between the pre-test and post-test measurements of the women in the experimental group.
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2017
Primary Completion (Actual)
September 30, 2017
Study Completion (Actual)
October 15, 2017
Study Registration Dates
First Submitted
February 21, 2021
First Submitted That Met QC Criteria
February 28, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
February 28, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Approval No: 2017-3/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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