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PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors

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ClinicalTrials.gov Identifier: NCT04780633
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Manolya Parlas, Ataturk University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Genital Infection Female Behavioral: Precede-Proceed based Training Program on Genital Hygiene Behaviors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of a PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors: A Randomized Controlled Trial
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : October 15, 2017

Arm Intervention/treatment
Experimental: Precede-Proceed based Training Program
The experimental group is the group in which five training sessions interventions are applied.
Behavioral: Precede-Proceed based Training Program on Genital Hygiene Behaviors
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study was conducted women who diagnosed with genital infections.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780633


Locations
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Turkey
Manolya Parlas
Izmir, None Selected, Turkey, 35210
Sponsors and Collaborators
Ataturk University
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Responsible Party: Manolya Parlas, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier: NCT04780633    
Other Study ID Numbers: Approval No: 2017-3/20
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manolya Parlas, Ataturk University:
Genital hygiene behavior
Women's health
Precede-Proceed model
Health education
Nursing