PostmenopauseEHHLI-MNPNCT07839416
On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women
A study testing Hybrid Health Literacy Education in people with Postmenopause and Sexual Function, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized controlled study will evaluate whether a hybrid health literacy education program improves sexual function and digital health literacy in postmenopausal women. Hybrid education combines in-person and online sessions. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause, Sexual Function, Health Literacy
- What is being tested?
- Hybrid Health Literacy Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 45-60 years. Postmenopausal status, defined as at least 12 months since the last menstrual period.
- Willing and able to provide written informed consent. Able to use a smartphone, tablet, or computer and participate in online sessions.
- Able to read and write in Turkish.
Who cannot join
- Serious systemic disease, such as heart failure, renal failure, liver failure, or uncontrolled hypertension.
- A diagnosis of depression, an anxiety disorder, dementia, or another serious psychiatric condition.
- A history of pelvic surgery or a current vaginal infection. Current use of hormone therapy. Regular use of medications that may affect sexual function, such as antidepressants.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Kahramanmaraş Sütçü İmam Universty
Kahramanmaraş, Kahramanmaraş, 46100
HATİCE GÜL ÖZTAŞ, 05428267629, h.gul_akbaba@hotmail.com.tr
EMEL GÜÇLÜ CİHAN, phd, emel_guclu4606@hotmail.com
Kahramanmaraş Sütçü İmama Universty
Kahramanmaraş, Kahramanmaraş, 46100
HATİCE ÖZTAŞ, DIRECTOR, 05428267629, h.gul_akbaba@hotmail.com.tr
EMEL GÜÇLÜ CİHAN, phd, emel_guclu4606@hotmail.com
About this study
Official title: Effects of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Postmenopausal Women
This randomized controlled study will evaluate whether a hybrid health literacy education program improves sexual function and digital health literacy in postmenopausal women. Hybrid education combines in-person and online sessions.
The study will include 128 women aged 45-60 years who have not had a menstrual period for at least 12 months. Participants will be recruited from the gynecology and obstetrics outpatient clinic at Kahramanmaraş Sütçü İmam University Hospital in Türkiye and randomly assigned to an education group or a usual-care group, with 64 women in each group.
Read more
The education group will receive a midwife-led program consisting of one in-person session and two online sessions over three weeks. The sessions will cover sexual health during menopause, finding and evaluating reliable online health information, and using this information in daily life. Women in the usual-care group will continue to receive routine health services without additional study education.
Participants in both groups will complete questionnaires assessing sexual function and digital health literacy before and after the intervention period. Researchers will compare changes between the groups to assess the effects of the education program.
Read the detailed description
The intervention is designed to help postmenopausal women access, understand, critically evaluate, and apply health information relevant to sexual well-being. It combines sexual health education with practical activities aimed at strengthening digital health literacy.
The first session, delivered in person, introduces health literacy and sexual changes associated with menopause. Topics include changes in sexual desire, vaginal dryness, discomfort during intercourse, body awareness, and communication with a partner. Activities include discussion of short educational texts, clarification of unfamiliar health terms, breathing and relaxation techniques, and guided pelvic floor muscle exercises.
The second session, delivered online, focuses on finding reliable health information and evaluating online content. Participants will discuss how to assess the source, scientific basis, currency, and potential commercial interests of health information. Scenario-based activities will help participants compare different recommendations and consider their relevance to individual needs.
The third session, also delivered online, focuses on applying information in daily life. Participants will develop personal plans addressing pelvic floor exercises, partner communication, and informed decisions about sexual health practices. Information about vaginal moisturizers and lubricants will be provided for educational purposes; no medication or product will be assigned as a study treatment. Discussion of practical difficulties and educator feedback will reinforce the skills covered during the program.
Questionnaires will be administered using printed forms or Google Forms. Responses will be coded to protect participant confidentiality. The analysis will evaluate between-group differences and changes over time in sexual function and digital health literacy.
- Being tested
- Hybrid Health Literacy Education
- Keywords
- Postmenopausal Women, Sexual Function, Health Literacy, Digital Health Literacy, Hybrid Education, Midwife-Led Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Health Literacy EducationBehavioural
A midwife-led education program delivered over three weeks through one in-person session and two online sessions. The program covers sexual health during menopause, pelvic floor exercises, partner communication, and skills for finding, evaluating, and applying reliable online health information.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Health Literacy Education | Experimental | Participants will receive a midwife-led hybrid health literacy education program consisting of three sessions over three weeks: one in-person session and two online sessions. The program will address sexual health during menopause, body awareness, pelvic floor exercises, partner communication, and skills for finding, evaluating, and applying reliable online health information. Educational activities will include discussions, practical exercises, scenario-based learning, and development of personal plans for applying the information in daily life. Receives: Behavioral: Hybrid Health Literacy Education |
| control group | No intervention | Participants will receive routine health services without additional study education and complete the same assessments as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Female Sexual Function Index (FSFI) Total Score
Sexual function will be assessed using the validated Turkish version of the Female Sexual Function Index (FSFI), a 19-item self-report questionnaire covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The questionnaire assesses sexual function over the preceding four weeks. The weighted domain scores are summed to obtain a total score ranging from 2 to 36, with higher scores indicating better sexual function. Change will be calculated as the post-intervention total score minus the baseline total score. Positive change scores indicate improvement. Changes will be compared between the intervention and control groups.
Measured: 3 week
Secondary outcomes (1)
Change From Baseline in Digital Health Literacy Scale Total Score
Digital health literacy will be assessed using the 18-item Turkish version of the Digital Health Literacy Scale. The scale covers six domains: information searching, evaluating reliability, determining relevance, navigation skills, adding content, and protecting privacy. Each item is scored from 1 to 4, yielding a total score ranging from 18 to 72. Higher scores indicate greater digital health literacy. Change will be calculated as the post-intervention total score minus the baseline total score. Positive change scores indicate improvement. Changes will be compared between the intervention and control groups.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion5 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a two-arm, parallel-group randomized controlled design. Participants will be assigned in a 1:1 ratio to either a hybrid health literacy education group or a usual-care control group using computer-generated randomization. Both groups will be assessed at baseline and after the three-week intervention period.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839416
- Sponsor's protocol ID
- KahramanmaraşSIU13
- Acronym
- EHHLI-MNP
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers to protect participant privacy, given the sensitive nature of the sexual health information collected. Study findings will be disseminated in aggregate form through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07839416
- Acronym / sponsor ID
- EHHLI-MNP / KahramanmaraşSIU13
- Keywords
- Postmenopausal Women, Sexual Function, Health Literacy, Digital Health Literacy, Hybrid Education, Midwife-Led Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Sep 2026 (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.
This randomized controlled study will evaluate whether a hybrid health literacy education program improves sexual function and digital health literacy in postmenopausal women. Hybrid education combines in-person and online sessions.
The study will include 128 women aged 45-60 years who have not had a menstrual period for at least 12 months. Participants will be recruited from the gynecology and obstetrics outpatient clinic at Kahramanmaraş Sütçü İmam University Hospital in Türkiye and randomly assigned to an education group or a usual-care group, with 64 women in each group.
The education group will receive a midwife-led program consisting of one in-person session and two online sessions over three weeks. The sessions will cover sexual health during menopause, finding and evaluating reliable online health information, and using this information in daily life. Women in the usual-care group will continue to receive routine health services without additional study education.
Participants in both groups will complete questionnaires assessing sexual function and digital health literacy before and after the intervention period. Researchers will compare changes between the groups to assess the effects of the education program.
Detailed description
The intervention is designed to help postmenopausal women access, understand, critically evaluate, and apply health information relevant to sexual well-being. It combines sexual health education with practical activities aimed at strengthening digital health literacy.
The first session, delivered in person, introduces health literacy and sexual changes associated with menopause. Topics include changes in sexual desire, vaginal dryness, discomfort during intercourse, body awareness, and communication with a partner. Activities include discussion of short educational texts, clarification of unfamiliar health terms, breathing and relaxation techniques, and guided pelvic floor muscle exercises.
The second session, delivered online, focuses on finding reliable health information and evaluating online content. Participants will discuss how to assess the source, scientific basis, currency, and potential commercial interests of health information. Scenario-based activities will help participants compare different recommendations and consider their relevance to individual needs.
The third session, also delivered online, focuses on applying information in daily life. Participants will develop personal plans addressing pelvic floor exercises, partner communication, and informed decisions about sexual health practices. Information about vaginal moisturizers and lubricants will be provided for educational purposes; no medication or product will be assigned as a study treatment. Discussion of practical difficulties and educator feedback will reinforce the skills covered during the program.
Questionnaires will be administered using printed forms or Google Forms. Responses will be coded to protect participant confidentiality. The analysis will evaluate between-group differences and changes over time in sexual function and digital health literacy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a two-arm, parallel-group randomized controlled design. Participants will be assigned in a 1:1 ratio to either a hybrid health literacy education group or a usual-care control group using computer-generated randomization. Both groups will be assessed at baseline and after the three-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Health Literacy Education | Experimental | Behavioral: Hybrid Health Literacy EducationParticipants will receive a midwife-led hybrid health literacy education program consisting of three sessions over three weeks: one in-person session and two online sessions. The program will address sexual health during menopause, body awareness, pelvic floor exercises, partner communication, and skills for finding, evaluating, and applying reliable online health information. Educational activities will include discussions, practical exercises, scenario-based learning, and development of personal plans for applying the information in daily life. |
| control group | No intervention | –Participants will receive routine health services without additional study education and complete the same assessments as the intervention group. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 45-60 years. Postmenopausal status, defined as at least 12 months since the last menstrual period.
- Willing and able to provide written informed consent. Able to use a smartphone, tablet, or computer and participate in online sessions.
- Able to read and write in Turkish.
Key exclusion criteria (3 listed)
- Serious systemic disease, such as heart failure, renal failure, liver failure, or uncontrolled hypertension.
- A diagnosis of depression, an anxiety disorder, dementia, or another serious psychiatric condition.
- A history of pelvic surgery or a current vaginal infection. Current use of hormone therapy. Regular use of medications that may affect sexual function, such as antidepressants.
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 |
|---|---|---|
| Hybrid Health Literacy EducationA midwife-led education program delivered over three weeks through one in-person session and two online sessions. The program covers sexual health during menopause, pelvic floor exercises, partner communication, and skills for finding, evaluating, and applying reliable online health information. | Behavioural | Hybrid Health Literacy Education |
Primary outcome
Change From Baseline in Female Sexual Function Index (FSFI) Total Score
Time frame: 3 week
Sexual function will be assessed using the validated Turkish version of the Female Sexual Function Index (FSFI), a 19-item self-report questionnaire covering six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The questionnaire assesses sexual function over the preceding four weeks. The weighted domain scores are summed to obtain a total score ranging from 2 to 36, with higher scores indicating better sexual function. Change will be calculated as the post-intervention total score minus the baseline total score. Positive change scores indicate improvement. Changes will be compared between the intervention and control groups.
1 secondary outcome
Change From Baseline in Digital Health Literacy Scale Total Score
Time frame: 3 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers to protect participant privacy, given the sensitive nature of the sexual health information collected. Study findings will be disseminated in aggregate form through scientific publications and presentations.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Health Literacy Education in people with Postmenopause and Sexual Function, run by Kahramanmaras Sutcu Imam University at 2 sites 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HATİCE GÜL ÖZTAŞ, PHD (0542826762 ext. 4628, haticeguloztas@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Female Sexual Function Index (FSFI) Total Score (time frame: 3 week). 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 24 Sep 2026.