ClinicalTrials.gg
Not yet recruitingNCT07839416EHHLI-MNPUpdated Sep 24, 2026

On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women

An interventional study of Hybrid Health Literacy Education in Postmenopause, Sexual Function and Health Literacy, sponsored by Kahramanmaras Sutcu Imam University. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study 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.

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.

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.

02

Conditions studied

  • Postmenopause
  • Sexual Function
  • Health Literacy
  • Digital Health Literacy

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Keywords

  • Postmenopausal Women
  • Sexual Function
  • Health Literacy
  • Digital Health Literacy
  • Hybrid Education
  • Midwife-Led Education
03

In context

Literacy

201 studies on the registry are indexed under Literacy; 69 are open to participants now.

This study's planned enrollment of 128 is close to the median of 124 across 170 interventional studies indexed under Literacy.

Browse Literacy studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 198 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women aged 45-60 years. status, defined as at least 12 months since the last menstrual period.

Willing and able to provide written . Able to use a smartphone, tablet, or computer and participate in online sessions.

Able to read and write in Turkish.

Exclusion criteria

Exclusion Criteria:

  • 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    Hybrid Health Literacy Education

    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.

    Behavioral: Hybrid Health Literacy Education

  • No intervention
    control group

    Participants will receive routine health services without additional study education and complete the same assessments as the intervention group.

Interventions

  • BehavioralHybrid Health Literacy Education

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 3 week

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Nov 2026, 1 month later.

Of 115 non-industry interventional studies with no phase under Literacy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's planned 1 month is below that.

Counting every sponsor, half of 117 studies reached it within 11 months; a quarter within 4 and three quarters within 19.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2026
First posted
Sep 24, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Nov 5, 2026
CompletionEst.
Dec 30, 2026
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07839416
Responsible party
Hatice Gul OZTAS (Assoc. Prof. Dr., Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Sep 24, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Nov 5, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 24, 2026

Study contacts

HATİCE GÜL ÖZTAŞ, PHD
Contact
haticeguloztas@ksu.edu.tr
0542826762 ext. 4628

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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