[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657441":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":36,"overallOfficials":17,"centralContacts":41,"locations":48,"responsibleParty":77,"collaborators":17,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":17,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":109,"whyStopped":17,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Kahramanmaras Sutcu Imam University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14],{"measure":15,"description":16,"timeFrame":12},"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.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":6,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","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":23,"maskingDescription":17,"whoMasked":17},"NONE","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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nQuestionnaires 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.",[26,32],{"label":27,"type":28,"description":29,"interventionNames":30},"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.",[31],"Behavioral: Hybrid Health Literacy Education",{"label":33,"type":34,"description":35,"interventionNames":17},"control group","NO_INTERVENTION","Participants will receive routine health services without additional study education and complete the same assessments as the intervention group.",[37],{"type":38,"name":27,"description":39,"armGroupLabels":40,"otherNames":17},"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.",[27],[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"HATİCE GÜL ÖZTAŞ, PHD","CONTACT","0542826762","4628","haticeguloztas@ksu.edu.tr",[49,68],{"facility":50,"status":17,"city":51,"state":51,"zip":52,"country":53,"countryCode":17,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Kahramanmaraş Sütçü İmam Universty","Kahramanmaraş","46100","Turkey (Türkiye)",{"type":55,"coordinates":56},"Point",[57,58],36.92641,37.5847,{"lat":58,"lon":57},[61,65],{"name":62,"role":44,"phone":63,"phoneExt":17,"email":64},"HATİCE GÜL ÖZTAŞ","05428267629","h.gul_akbaba@hotmail.com.tr",{"name":66,"role":44,"phone":17,"phoneExt":17,"email":67},"EMEL GÜÇLÜ CİHAN, phd","emel_guclu4606@hotmail.com",{"facility":69,"status":17,"city":51,"state":51,"zip":52,"country":53,"countryCode":17,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Kahramanmaraş Sütçü İmama Universty",{"type":55,"coordinates":71},[57,58],{"lat":58,"lon":57},[74,76],{"name":75,"role":44,"phone":63,"phoneExt":17,"email":64},"HATİCE ÖZTAŞ, DIRECTOR",{"name":66,"role":44,"phone":17,"phoneExt":17,"email":67},{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Hatice Gul OZTAS","Assoc. Prof. Dr.","100657441","on-the-effect-of-a-hybrid-health-literacy-intervention-on-sexual-function-and-digital-health-literacy-in-menopausal-women-100657441",false,"NCT07839416","On the Effect of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Menopausal Women","Effects of a Hybrid Health Literacy Intervention on Sexual Function and Digital Health Literacy in Postmenopausal Women","EHHLI-MNP","Inclusion Criteria:\n\n* Women aged 45-60 years. Postmenopausal status, defined as at least 12 months since the last menstrual period.\n\nWilling and able to provide written informed consent. Able to use a smartphone, tablet, or computer and participate in online sessions.\n\nAble to read and write in Turkish.\n\nExclusion Criteria:\n\n* Serious systemic disease, such as heart failure, renal failure, liver failure, or uncontrolled hypertension.\n\nA diagnosis of depression, an anxiety disorder, dementia, or another serious psychiatric condition.\n\nA 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.",true,"FEMALE","45 Years","60 Years",{"count":94,"type":95},128,"ESTIMATED","INTERVENTIONAL",[98],"NA","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.\n\nThe 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.\n\nThe 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.\n\nParticipants 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.",[101,102,103,104],"Postmenopause","Sexual Function","Health Literacy","Digital Health Literacy",[106,102,103,104,107,108],"Postmenopausal Women","Hybrid Education","Midwife-Led Education","NOT_YET_RECRUITING","2026-09-18",{"date":112,"type":113},"2026-09-24","ACTUAL",{"date":115,"type":95},"2026-10-01",{"date":117,"type":95},"2026-12-30",{"name":5,"class":6},2]