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On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women (EHHLI-MNP)

2026年9月18日 更新者:Hatice Gul OZTAS、Kahramanmaras Sutcu Imam University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

128

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

45年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

无干预:control group

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Female Sexual Function Index (FSFI) Total Score
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Digital Health Literacy Scale Total Score
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2026年11月5日

研究完成 (估计的)

2026年12月30日

研究注册日期

首次提交

2026年9月18日

首先提交符合 QC 标准的

2026年9月18日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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