The Effect of Web Based Genital Hygiene Education Provided to Orthopedically Disabled Women

January 25, 2021 updated by: Sidar Gül, Siirt University

A 15-Week Randomized Controlled Trial in Orthopedically Disabled Women

The aim of this study is to determine the effect of web-based genital hygiene education provided to orthopedically disabled women on self care agency and genital hygiene behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It was a randomized controlled trial. The women in the experimental group were given web-based genital hygiene education that continued for seven weeks. No intervention was applied to the women in the control group.

Study Type

Interventional

Enrollment (Actual)

62

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

  • Turkey
      • Malatya, Turkey, 44280
        • Inonu University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Being orthopedically handicapped
  • Being literate, being over the age of 18
  • Having access to the internet
  • Being able to use the internet/computer
  • Being able to maintain genital hygiene individually.

Exclusion Criteria:

  • The inability to use the internet
  • Not being a member of the website
  • Having mental retardation
  • Being dependent on someone else to maintain genital hygiene (bedridden, with spasticity)
  • No willing to complete the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Partivipants recieved web based genital hygiene education for seven week
Other: web based education
Expert support and consultancy were received for the design and preparation of the web page.
No Intervention: Control
No intervention was applied to the women in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Introductory Questionnaire
Time Frame: Baseline
The introductory questionnaire created for descriptive expressions
Baseline
Change from the Baseline Self-Care Agency Scale Points at 7th and 15th weeks
Time Frame: Baseline, at the end of the 7th week, at the end of the 15th week
Self-Care Agency Scale was used to determine the self-care skills and abilities of the participants. It is a 5-point Likert-type scale with 35 items. Each item of the scale is scored between 0 and 4 (0= very uncharacteristic of me, 4= very characteristic of me). In the scale, 8 items (3, 6, 9, 13, 19, 22, 26, and 31) are scored reversely (0= very characteristic of me, 4= very uncharacteristic of me). The scale is evaluated over 140 points. In evaluation, the score over 120 points is defined as high, the score between 82 and 120 points is defined as moderate, and the score below 82 points is defined as low.
Baseline, at the end of the 7th week, at the end of the 15th week
Change from the Genital Hygiene Behavior Scale Points at 7th and 15th weeks
Time Frame: Baseline, at the end of the 7th week, at the end of the 15th week
The Genital Hygiene Behavior Scale was used to determine the genital hygiene behaviors of the participants.It is a 5-point Likert-type scale with 23 items consisting of three sub-dimensions. The sub-dimensions of the scale are "General Hygiene (the first 12 items)", "Menstrual Hygiene (items between 13 and 20), and "Abnormal Finding Awareness (items between 21 and 23 )". Participants rate each item from 1 to 5 according to their suitability (1 = strongly disagree, 5 = Strongly agree). In the scale, 5 items (7, 14, 19, 20, 23) are scored reversely (1 = strongly agree, 5 = Strongly disagree). The highest score that can be obtained from the scale is 115 and the lowest score is 23. High scores indicate positive genital hygiene behavior.
Baseline, at the end of the 7th week, at the end of the 15th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siirt University

Collaborators

Inonu University

Investigators

  • Study Director: Yurdagul Yagmur, Prof, Inonu University

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)

December 1, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

July 10, 2020

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1648

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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