[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659189":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":52,"overallOfficials":63,"centralContacts":72,"locations":81,"responsibleParty":95,"collaborators":30,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":30,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":30,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":126,"whyStopped":30,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Konya Beyhekim Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Menopause Rating Scale (MRS) Total Score at 24 Weeks","Assessed using the Menopause Rating Scale (MRS), which evaluates somatic, psychological, and urogenital symptoms across 11 items. Each item is scored on a 5-point Likert scale (0=none to 4=very severe), yielding a total score ranging from 0 to 44. Higher scores reflect greater symptom severity. Change is defined as the score at 24 weeks minus the baseline score.","Baseline and 24 weeks",[14,17,20,24,27],{"measure":15,"description":16,"timeFrame":12},"Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at 24 Weeks","Subjective sleep quality over the previous month assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, where scores greater than 5 indicate poor sleep quality. Higher scores reflect worse sleep quality. Change is calculated as the score at 24 weeks minus the baseline score.",{"measure":18,"description":19,"timeFrame":12},"Change from Baseline in Generalized Anxiety Disorder-7 (GAD-7) Score at 24 Weeks","Anxiety symptoms over the previous two weeks assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. The total score ranges from 0 to 21, categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21) anxiety. Higher scores indicate greater anxiety symptom severity. Change is defined as the score at 24 weeks minus the baseline score.",{"measure":21,"description":22,"timeFrame":23},"Rate of New Medication Initiation (Antidepressants or HRT) at 24 Weeks","Percentage of participants who were prescribed a new antidepressant or systemic hormone replacement therapy (HRT) during the 24-week follow-up period, assessed via electronic health records (e-Nabiz system).","From baseline up to 24 weeks",{"measure":25,"description":26,"timeFrame":23},"Number of Emergency Department Visits at 24 Weeks","Total number of all-cause and symptom-related emergency department admissions per participant during the 24-week study period, extracted from electronic health records (e-Nabiz system).",{"measure":28,"description":29,"timeFrame":23},"Total Count of NSAID Prescriptions at 24 Weeks","Total number of non-steroidal anti-inflammatory drug (NSAID) prescriptions filled per participant over the 24-week follow-up period, assessed via electronic health records (e-Nabiz system)",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Participants are randomly allocated in a 1:1 ratio using a computer-generated block randomization list (block size of 4) via sequentially numbered, opaque, sealed envelopes into either the lifestyle intervention group or the control group.","SUPPORTIVE_CARE",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","Background and Objective:\n\nIn perimenopausal and postmenopausal women aged 40-55 presenting to primary care, this study evaluates the impact of a structured lifestyle modification program on menopausal symptoms, sleep quality, and anxiety compared with a control group.\n\nMethods and Design:\n\nThis prospective, parallel-group, randomized controlled trial is conducted at Selcuklu Ardicli Educational Family Health Center (Units 218, 225, 239, 240) affiliated with Konya Beyhekim Training and Research Hospital.\n\nEligible women aged 40-55 years with baseline MRS scores between 9 and 31 will be randomized in a 1:1 allocation ratio using a computer-generated block randomization list (block size of 4) via sequentially numbered, opaque, sealed envelopes:\n\nIntervention Group: Receives face-to-face structured educational counseling covering physical activity recommendations, dietary guidance, sleep hygiene, and stress reduction principles at baseline. Re-evaluation is performed face-to-face at 24 weeks.\n\nControl Group: Receives standard clinical care without structured lifestyle education. At the end of the 24-week follow-up and completion of final questionnaires, the same lifestyle education is provided to ensure equal contribution to both groups.\n\nOutcome Assessments:\n\nQuestionnaires administered at baseline and Week 24:\n\nMenopause Rating Scale (MRS) for somatic, psychological, and urogenital symptoms.\n\nPittsburgh Sleep Quality Index (PSQI) for subjective sleep quality over the previous month.\n\nGeneralized Anxiety Disorder-7 (GAD-7) for anxiety symptoms over the past two weeks.\n\nIn addition, national electronic health records (e-Nabız) will be reviewed at Month 6 for new antidepressant initiation, systemic hormone replacement therapy initiation, prescription counts of non-steroidal anti-inflammatory drugs (NSAIDs), and emergency department visits.\n\nSample Size Calculation:\n\nCalculated using G\\*Power 3.1.9.4 with repeated measures ANOVA (within-between interaction; effect size f=0.20, alpha=0.05, power=0.95, 2 groups, 2 measurements, correlation=0.50), yielding a minimum of 84 participants. Accounting for a 10% dropout rate, a total of 100 participants (50 intervention group, 50 control group) will be enrolled.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Lifestyle Intervention Group (Education First)","EXPERIMENTAL","Participants receive structured education on healthy lifestyle modifications during the menopausal transition, focusing on regular physical activity, dietary guidance, sleep hygiene, and stress reduction principles at baseline. Re-evaluation is performed face-to-face at 24 weeks.",[45],"Behavioral: Structured Lifestyle Education",{"label":47,"type":48,"description":49,"interventionNames":50},"Control Group (Wait-list Control)","ACTIVE_COMPARATOR","Participants receive standard clinical care without structured lifestyle education during the 24-week study period. Follow-up questionnaires are completed at 24 weeks, after which the healthy living educational information is provided.",[51],"Other: Standard Care (in control arm)",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":30},"BEHAVIORAL","Structured Lifestyle Education","Face-to-face structured educational counseling covering regular physical activity recommendations, dietary guidance, sleep hygiene principles, and stress management strategies tailored for perimenopausal and postmenopausal women.",[41],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":30},"OTHER","Standard Care (in control arm)","Participants continue with standard routine care and health follow-up without the structured menopause lifestyle education during the first 6 months.",[47],[64,67,70],{"name":65,"affiliation":5,"role":66},"İBRAHİM SOLAK, MD,AssocProf","PRINCIPAL_INVESTIGATOR",{"name":68,"affiliation":5,"role":69},"MUSTAFA YASİN ÖZTOPRAK, MD","STUDY_DIRECTOR",{"name":71,"affiliation":5,"role":69},"ARİFE KOÇAK, MD",[73,77],{"name":71,"role":74,"phone":75,"phoneExt":30,"email":76},"CONTACT","+905050696295","arifekoccak@gmail.com",{"name":78,"role":74,"phone":79,"phoneExt":30,"email":80},"İBRAHİM SOLAK, MD","+90533-659-11-71","isolaktr@yahoo.com",[82],{"facility":5,"status":30,"city":83,"state":83,"zip":84,"country":85,"countryCode":30,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Konya","42130","Turkey (Türkiye)",{"type":87,"coordinates":88},"Point",[89,90],32.48464,37.87135,{"lat":90,"lon":89},[93,94],{"name":71,"role":74,"phone":75,"phoneExt":30,"email":76},{"name":78,"role":66,"phone":30,"phoneExt":30,"email":30},{"type":66,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"İbrahim Solak","Associate Professor, MD","100659189","effect-of-lifestyle-intervention-on-menopausal-symptoms-sleep-quality-and-anxiety-in-peri--and-postmenopausal-women-100659189",false,"NCT07860645","Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Peri- and Postmenopausal Women","Evaluation of the Effect of Lifestyle Intervention on Menopausal Symptoms, Sleep Quality, and Anxiety in Perimenopausal and Postmenopausal Women: A Prospective, Randomized Controlled Study","Inclusion Criteria:\n\nFemale patients aged 40 to 55 years presenting to the Educational Family Health Center\n\nCategorized into one of the defined reproductive stages: late perimenopause, early postmenopause (0-5 years), or late postmenopause (\\>5 years)\n\nReporting clinically significant complaints in at least one key menopausal domain: hot flashes\u002Fnight sweats, sleep problems, or mood changes (anxiety, irritability, depressive mood)\n\nBaseline Menopause Rating Scale (MRS) total score between 9 and 31 (inclusive)\n\nLiterate and capable of comprehending and completing study questionnaires\n\nAccessible for the 24-week follow-up evaluation\n\nHistory of compensated chronic disease (e.g., controlled diabetes mellitus, hypertension, atherosclerotic cardiovascular disease, hyperlipidemia)\n\nProvision of written informed consent\n\nExclusion Criteria:\n\nAge younger than 40 or older than 55 years\n\nHistory of hysterectomy or bilateral oophorectomy\n\nSevere cognitive impairment or inability to complete questionnaires\n\nInability or refusal to provide written informed consent\n\nPreviously diagnosed severe psychiatric illness (e.g., psychotic disorders, bipolar disorder)\n\nBaseline Menopause Rating Scale (MRS) total score \\\u003C9 or ≥32\n\nHistory of decompensated chronic disease (e.g., uncontrolled hypertension, unstable cardiovascular disease, decompensated diabetes mellitus)","FEMALE","40 Years","55 Years",{"count":109,"type":110},100,"ESTIMATED","INTERVENTIONAL",[113],"NA","Menopause is a biological process characterized by the permanent cessation of menstruation, often accompanied by vasomotor symptoms, sleep disturbances, anxiety, and impaired quality of life. In primary healthcare settings, structured lifestyle interventions offer low-cost, safe, and sustainable non-pharmacological management strategies.\n\nThe objective of this prospective, randomized controlled trial is to evaluate whether a structured lifestyle educational intervention leads to significant improvements in menopausal symptom severity, sleep quality, and anxiety levels compared with a control group receiving routine clinical care among perimenopausal and postmenopausal women aged 40 to 55 years. Primary and secondary outcomes are evaluated using the Menopause Rating Scale (MRS), Pittsburgh Sleep Quality Index (PSQI), and Generalized Anxiety Disorder-7 (GAD-7) at baseline and at 24 weeks.",[116,117,118],"Perimenopause","Postmenopause","Menopause",[120,121,122,123,124,125],"Menopausal Symptoms","Lifestyle Intervention","Sleep Quality","Anxiety","Primary Health Care","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-09-30",{"date":129,"type":130},"2026-10-06","ACTUAL",{"date":132,"type":110},"2026-10-15",{"date":134,"type":110},"2027-07-31",{"name":5,"class":6},1]