- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06095193
The Effect of Education on Vaginal Effects of Menopausal Women
October 18, 2023 updated by: Ayşe Elkoca, Gaziantep Islam Science and Technology University
The Effect of Education Applied to Women in Menopause on the Daily Effects of Vaginal Aging, Avoidance of Sexuality and Sexual Stress
The aim of our study is to examine the effect of education applied to women in menopause on the daily effects of vaginal aging, avoidance of sexuality and sexual stress.
It is a pretest-posttest randomized controlled experimental study.
The universe of the research; It consisted of menopausal women over the age of 45 who attended courses at Özgecan Cultural Center and Binevler Social Facility in Gaziantep.
The sample of the research consisted of 102 people determined by the GPower method and determined by simple random method among all women who volunteered to participate in the study.
Introductory Information Form, Daily Effect of Vaginal Aging Scale, Sexuality Avoidance Decision Balance Scale and Sexuality Avoidance Self-Efficacy Scale, Female Sexual Distress Scale were used to collect the research data. .
The data will be collected face to face with the form prepared by the researchers after mass announcements and explanations are made to the women.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Menopause is an inevitable event in every woman's life.
This is a period in which women adapt to physical, emotional, mental and hormonal changes in their lives.
During this process, the woman's menstrual cycle is permanently interrupted.
The aim of our study is to examine the effect of education applied to women in menopause on the daily effects of vaginal aging, avoidance of sexuality and sexual stress.
It is a pretest-posttest randomized controlled experimental study.
This research was conducted between October 2023 and December 2023 with menopausal women over the age of 45 who attended courses at Özgecan Cultural Center and Binevler Social Facility in Gaziantep.
The universe of the research; It consisted of menopausal women over the age of 45 who attended courses at Özgecan Cultural Center and Binevler Social Facility in Gaziantep.
The sample of the research consisted of 102 people determined by the GPower method and determined by simple random method among all women who volunteered to participate in the study.
Introductory Information Form, Daily Effect of Vaginal Aging Scale, Sexuality Avoidance Decision Balance Scale and Sexual Avoidance Self-Efficacy Scale, Female Sexual Distress Scale were used to collect the research data. .
The data will be collected face to face with the form prepared by the researchers after mass announcements and explanations are made to the women.
Study Type
Interventional
Enrollment (Estimated)
102
Phase
- Not Applicable
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being able to understand what you read
- being in menopause
- continue throughout education
- Being 45 years or older
Exclusion Criteria:
- being under 45
- having a mental problem
- not being in menopause
- not attending one of the training sessions
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
No intervention will be made
|
|
Experimental: Experimental: menopause education
Women will be taught the physiology of female reproductive organs, physiology of menopause, vaginal symptoms in menopause, sexual myths in menopause and practices that will support sexuality in menopause, in 50 minutes for 4 weeks.
|
Women will be taught the physiology of female reproductive organs, physiology of menopause, vaginal symptoms in menopause, sexual myths in menopause and practices that will support sexuality in menopause, in 50 minutes for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of menopause education
Time Frame: 6 week
|
Improvement in women's symptoms as a result of training
|
6 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scale-1
Time Frame: one week and last week
|
DAILY IMPACT OF VAGINAL AGING SCALE
|
one week and last week
|
Scale-2
Time Frame: one week and last week
|
Female Sexual Distress Scale
|
one week and last week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
October 25, 2023
Primary Completion (Estimated)
December 30, 2023
Study Completion (Estimated)
February 28, 2024
Study Registration Dates
First Submitted
October 5, 2023
First Submitted That Met QC Criteria
October 18, 2023
First Posted (Actual)
October 23, 2023
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- GaziantepIslamSTU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Indicate if there is a plan to make individual participant data (IPD) available to other researchers.
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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