NCT06095193

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 5, 2023

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of menopause education

    Improvement in women's symptoms as a result of training

    6 week

Secondary Outcomes (2)

  • Scale-1

    one week and last week

  • Scale-2

    one week and last week

Study Arms (2)

Experimental: menopause education

EXPERIMENTAL

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.

Behavioral: menopause education

control group

NO INTERVENTION

No intervention will be made

Interventions

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.

Experimental: menopause education

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being able to understand what you read
  • being in menopause
  • continue throughout education
  • Being 45 years or older

You may not qualify if:

  • being under 45
  • having a mental problem
  • not being in menopause
  • not attending one of the training sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elkoca A, Ayar D. Effects of education given in the menopausal period on the day-to-day impact of vaginal aging, self-efficacy in sexual abstinence and sexual distress: A randomized clinical trial. Women Health. 2025 Jan;65(1):4-18. doi: 10.1080/03630242.2024.2432934. Epub 2024 Dec 1.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof.Dr.

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 23, 2023

Study Start

October 25, 2023

Primary Completion

December 30, 2023

Study Completion

February 28, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Indicate if there is a plan to make individual participant data (IPD) available to other researchers.