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

NCT07839416 | Not Yet Recruiting

• 1 other identifier: KahramanmaraşSIU13
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postmenopause; Sexual Function; Health Literacy; Digital Health Literacy

Keywords

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

Outcome Measures

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.

  3 week

Secondary Outcomes (1)

• Change From Baseline in Digital Health Literacy Scale Total Score

  3 week

Study Arms (2)

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.

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.

Interventions

Hybrid Health Literacy Education BEHAVIORAL

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.

Hybrid Health Literacy Education

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Kahramanmaraş Sütçü İmam Universty

Kahramanmaraş, Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş, Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Central Study Contacts

HATİCE GÜL ÖZTAŞ, PHD

CONTACT

0542826762; haticeguloztas@ksu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)