On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women (EHHLI-MNP)
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.
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: HATİCE GÜL ÖZTAŞ, PHD
- Telefonnummer: 4628 0542826762
- E-post: haticeguloztas@ksu.edu.tr
Studiesteder
-
-
Kahramanmaraş
-
Kahramanmaraş, Kahramanmaraş, Tyrkia (Türkiye), 46100
- Kahramanmaraş Sütçü İmam Universty
-
Ta kontakt med:
- HATİCE GÜL ÖZTAŞ
- Telefonnummer: 05428267629
- E-post: h.gul_akbaba@hotmail.com.tr
-
Ta kontakt med:
- EMEL GÜÇLÜ CİHAN, phd
- E-post: emel_guclu4606@hotmail.com
-
Kahramanmaraş, Kahramanmaraş, Tyrkia (Türkiye), 46100
- Kahramanmaraş Sütçü İmama Universty
-
Ta kontakt med:
- EMEL GÜÇLÜ CİHAN, phd
- E-post: emel_guclu4606@hotmail.com
-
Ta kontakt med:
- HATİCE ÖZTAŞ, DIRECTOR
- Telefonnummer: 05428267629
- E-post: h.gul_akbaba@hotmail.com.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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.
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
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. |
|
Ingen inngripen: control group
Participants will receive routine health services without additional study education and complete the same assessments as the intervention group. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Female Sexual Function Index (FSFI) Total Score
Tidsramme: 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. |
3 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Digital Health Literacy Scale Total Score
Tidsramme: 3 week
|
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. |
3 week
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- KahramanmaraşSIU13
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .