MenopauseNCT06095193
The Effect of Education on Vaginal Effects of Menopausal Women
A study testing menopause education in people with Menopause and Aging, run by Gaziantep Islam Science and Technology University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Aging, Failure of Genital Response
- What is being tested?
- menopause education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being able to understand what you read
- being in menopause
- continue throughout education
- Being 45 years or older
Who cannot join
- being under 45
- having a mental problem
- not being in menopause
- not attending one of the training sessions
About this study
Official title: 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.
Read the 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.
- Conditions
- Menopause, Aging, Failure of Genital Response
- Being tested
- menopause education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menopause educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: menopause education |
| control group | No intervention | No intervention will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of menopause education
Improvement in women's symptoms as a result of training
Measured: 6 week
Secondary outcomes (2)
Scale-1
DAILY IMPACT OF VAGINAL AGING SCALE
Measured: one week and last week
Scale-2
Female Sexual Distress Scale
Measured: one week and last week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start25 Oct 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Elkoca, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095193
- Sponsor's protocol ID
- GaziantepIslamSTU
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indicate if there is a plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 39617952
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Applied to Women in Menopause on the Daily Effects of Vaginal Aging, Avoidance of Sexuality and Sexual Stress
- ClinicalTrials.gov ID
- NCT06095193
- Acronym / sponsor ID
- GaziantepIslamSTU
- Conditions
- Menopause, Aging, Failure of Genital Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: menopause education | Experimental | Behavioral: menopause educationWomen 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. |
| control group | No intervention | –No intervention will be made |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being able to understand what you read
- being in menopause
- continue throughout education
- Being 45 years or older
Key exclusion criteria (4 listed)
- being under 45
- having a mental problem
- not being in menopause
- not attending one of the training sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| menopause educationWomen 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. | Behavioural | Experimental: menopause education |
Primary outcome
Effectiveness of menopause education
Time frame: 6 week
Improvement in women's symptoms as a result of training
2 secondary outcomes
Scale-1
Time frame: one week and last week
Scale-2
Time frame: one week and last week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39617952Elkoca 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.
- Individual participant dataSharing planned: No. Indicate if there is a plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing menopause education in people with Menopause and Aging, run by Gaziantep Islam Science and Technology University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of menopause education (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06095193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.