SexualityNCT05560178
The Effect of Sexual Health Education Given to Women in the Postmenopausal Period on Sexual Life
A study testing SEXUAL HEALTH EDUCATION in people with Sexuality and Menopause, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
With this study, it is aimed to evaluate the effect of sexual health education given to women in the postmenopausal period on sexual myths, sexual distress and sexual quality of life. Type of Research The study was planned as a parallel group (experiment-control) randomized controlled trial. Read more about this study
- Who is it for?
- Ages 41 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexuality, Menopause, Sexual Behavior
- What is being tested?
- SEXUAL HEALTH EDUCATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Apr 2023
- 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 41 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate,
- Able to communicate verbally,
- Turkish speaking,
- No hearing or vision loss,
- Voluntarily participated in the research,
- Postmenopausal period,
Show all 10Show fewer
- Natural menopause,
- no sexual dysfunction,
- be less than 65 years old,
- good sexual function
Who cannot join
- Hormone replacement therapy
- Early menopause (before age 40)
- A chronic systemic disease and/or a psychiatric health problem
- Any sexual education before or during work
- Sexual dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karamanoğlu Mehmetbey University
Karaman
Serap Kırıcı, Investigator, 05436494623, adlicann23@gmail.com
About this study
With this study, it is aimed to evaluate the effect of sexual health education given to women in the postmenopausal period on sexual myths, sexual distress and sexual quality of life.
Type of Research The study was planned as a parallel group (experiment-control) randomized controlled trial.
Read the detailed description
Establishment of the Study Group: The Female Sexual Function Index (FSFI) was applied to the women who applied to the Obstetrics and Gynecology outpatient clinics of Karaman Training and Research Hospital to determine the study group, and the women who accepted to participate in the study in accordance with the sample selection criteria were applied to the study. General information about the study will be given and general consent will be taken for participation in the research. Then, the Individual Information Form, Sexual Myths Scale (SMS), Female Sexual Distress Scale (Revised- FSDS-R) and Sexual Life Quality Scale-Female (SILK-F) was applied. In accordance with the sample size determined by power analysis, the experimental and control groups were randomly assigned.
blinding Since it is not possible to blind the experimental and control groups in the study, only statistical blinding applied.
Application Steps of the Research Researcher; By introducing themselves to the experimental and control groups, verbal and written information was given about the subject of the research and the steps to be followed. Then, among the women determined by the researcher in accordance with the sample selection criteria, applications were made to the women who were allocated to the experimental group by randomization, and no intervention was made to those who were allocated to the control group.
For the Experimental Group; Sexual Health Education Program The women in the experimental group were given training in line with the "Sexual Health Education Manual for Postmenopausal Women" prepared by the researchers. The training plan of the research is as follows.
Education Plan (Sexual Health Education) Session Subject
- Female reproductive organs (Female internal and external reproductive organs and sexual anatomy), Male reproductive organs and sexual anatomy Definitions related to sexuality and sexual health (sexuality, sexual health, sexual intimacy, sexual intercourse, sexual behaviors, sexual function, sexual dysfunction)
- Sexual myths and taboos, sexual distress, sexual quality of life Female sexual function physiology and sexual response cycle, female sexual dysfunctions
- Definition of menopause, classification of menopause, factors affecting menopause, the effect of menopause on sexual life, changes in the postmenopausal period and its effect on sexual life
- Recommendations about changes in the postmenopausal period and sexual problems Kegel exercises, masturbation exercises
For the Control Group; Control Group: No intervention was made after the pre-tests were applied to the control group women. However, after the post-tests were applied, a sexual health education and training booklet was given to the control group, taking into account the right to be informed in terms of ethics.
- Conditions
- Sexuality, Menopause, Sexual Behavior
- Being tested
- SEXUAL HEALTH EDUCATION
- Keywords
- sexuality, sexual health, postmenapause
- Medical subject headings
- Sexuality, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEXUAL HEALTH EDUCATIONOther
Women in the intervention group will be given sexual health education once a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Training group | Experimental | women in the intervention group will be given sexual health education once a week for 4 weeks Receives: Other: SEXUAL HEALTH EDUCATION |
| No Intervention: control group | No intervention | Women will be monitored without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Myths Scale-SMS
It is a scale developed to describe sexual myths. The minimum score obtained from the scale is 28, and the maximum score is 140. The cronbach's alpha coefficient of the scale was found to be 0.91. In addition, the sub-dimensions' item scores can be summed to obtain sub-dimensions' scores. It is not the cut-off point of the scale, and the high score indicates that the sexual myths are high.
The Sexual Myths Scale-SMS will be used to assess sexual myths in each participant.
Measured: Time Frame: 13 weeks
Secondary outcomes (1)
Female Sexual Distress Scale-Revised- FSDS- R
Female Sexual Distress Scale, Derogatis et al. (2008) to measure personal distress related to sexuality in women with sexual dysfunction.
Responses to the items on the Likert-type scale consist of never (0), rarely (1), sometimes (2), often (3), or always (4). The lowest score that can be obtained from the FSDS-R is "0" and the highest score is "52". Higher scores indicate higher levels of sexual distress.
FSDS-R will be used to assess sexual myths in each participant.
Measured: Time Frame: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Apr 2022
- Primary completion27 Sep 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research, parallel group (experiment-control) randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Kırıcı, Necmettin Erbakan University
- Investigators
- Emel Ege, Professor, Study director, Necmettin Erbakan UniversitySerap Kırıcı, Investigator:, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560178
- Sponsor's protocol ID
- KMUserapkirici
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Health Education Given to Women in the Postmenopausal Period on Sexual Life
- ClinicalTrials.gov ID
- NCT05560178
- Acronym / sponsor ID
- KMUserapkirici
- Conditions
- Sexuality, Menopause, Sexual Behavior
- Keywords
- sexuality, sexual health, postmenapause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 27 Sep 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 29 Sep 2022 (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.
With this study, it is aimed to evaluate the effect of sexual health education given to women in the postmenopausal period on sexual myths, sexual distress and sexual quality of life.
Type of Research The study was planned as a parallel group (experiment-control) randomized controlled trial.
Detailed description
Establishment of the Study Group: The Female Sexual Function Index (FSFI) was applied to the women who applied to the Obstetrics and Gynecology outpatient clinics of Karaman Training and Research Hospital to determine the study group, and the women who accepted to participate in the study in accordance with the sample selection criteria were applied to the study. General information about the study will be given and general consent will be taken for participation in the research. Then, the Individual Information Form, Sexual Myths Scale (SMS), Female Sexual Distress Scale (Revised- FSDS-R) and Sexual Life Quality Scale-Female (SILK-F) was applied. In accordance with the sample size determined by power analysis, the experimental and control groups were randomly assigned.
blinding Since it is not possible to blind the experimental and control groups in the study, only statistical blinding applied.
Application Steps of the Research Researcher; By introducing themselves to the experimental and control groups, verbal and written information was given about the subject of the research and the steps to be followed. Then, among the women determined by the researcher in accordance with the sample selection criteria, applications were made to the women who were allocated to the experimental group by randomization, and no intervention was made to those who were allocated to the control group.
For the Experimental Group; Sexual Health Education Program The women in the experimental group were given training in line with the "Sexual Health Education Manual for Postmenopausal Women" prepared by the researchers. The training plan of the research is as follows.
Education Plan (Sexual Health Education) Session Subject
- Female reproductive organs (Female internal and external reproductive organs and sexual anatomy), Male reproductive organs and sexual anatomy Definitions related to sexuality and sexual health (sexuality, sexual health, sexual intimacy, sexual intercourse, sexual behaviors, sexual function, sexual dysfunction)
- Sexual myths and taboos, sexual distress, sexual quality of life Female sexual function physiology and sexual response cycle, female sexual dysfunctions
- Definition of menopause, classification of menopause, factors affecting menopause, the effect of menopause on sexual life, changes in the postmenopausal period and its effect on sexual life
- Recommendations about changes in the postmenopausal period and sexual problems Kegel exercises, masturbation exercises
For the Control Group; Control Group: No intervention was made after the pre-tests were applied to the control group women. However, after the post-tests were applied, a sexual health education and training booklet was given to the control group, taking into account the right to be informed in terms of ethics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Research, parallel group (experiment-control) randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental: Training group | Experimental | Other: SEXUAL HEALTH EDUCATIONwomen in the intervention group will be given sexual health education once a week for 4 weeks |
| No Intervention: control group | No intervention | –Women will be monitored without any intervention |
Who may qualify
- Ages
- 41 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Literate,
- Able to communicate verbally,
- Turkish speaking,
- No hearing or vision loss,
- Voluntarily participated in the research,
Key exclusion criteria (5 listed)
- Hormone replacement therapy
- Early menopause (before age 40)
- A chronic systemic disease and/or a psychiatric health problem
- Any sexual education before or during work
- Sexual dysfunction
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 |
|---|---|---|
| SEXUAL HEALTH EDUCATIONWomen in the intervention group will be given sexual health education once a week for 4 weeks | Other | Experimental: Training group |
Primary outcome
Sexual Myths Scale-SMS
Time frame: Time Frame: 13 weeks
It is a scale developed to describe sexual myths. The minimum score obtained from the scale is 28, and the maximum score is 140. The cronbach's alpha coefficient of the scale was found to be 0.91. In addition, the sub-dimensions' item scores can be summed to obtain sub-dimensions' scores. It is not the cut-off point of the scale, and the high score indicates that the sexual myths are high. The Sexual Myths Scale-SMS will be used to assess sexual myths in each participant.
1 secondary outcome
Female Sexual Distress Scale-Revised- FSDS- R
Time frame: Time Frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Emel Ege, Professor study director
Necmettin Erbakan University
Serap Kırıcı, Investigator: principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEXUAL HEALTH EDUCATION in people with Sexuality and Menopause, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 10 inclusion and 5 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Serap KIRICI, MSc (05436494623, adlicann23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Myths Scale-SMS (time frame: Time Frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2022.