[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426198":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":23,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":45,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Taipei Medical University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Web-based mind-body intervention with HRVB","EXPERIMENTAL","Both standard usual care and the web-based mind-body intervention with HRV biofeedback (MBI-HRVB) will be provided to the participants. The web-based mind-body intervention with HRV biofeedback program consisted of 5-week training sessions and breathing training.",[13],"Behavioral: Web-based mind-body intervention with HRVB",{"label":15,"type":10,"description":16,"interventionNames":17},"Web-based mind-body intervention","Both standard usual care and the web-based mind-body intervention will be provided to the participants. The web-based mind-body intervention program consisted of 5-week training sessions.",[18],"Behavioral: Web-based mind-body intervention",{"label":20,"type":21,"description":22,"interventionNames":23},"Control","NO_INTERVENTION","The women in the control group will receive the standard usual care provided at the fertility clinic. The standard care protocols encompass elements such as routine assessment and health education at each visit. Participants enrolled in the control group will be approached once a week by a nurse to provide health consultation about fertility treatment, medication, signs, and symptoms of discomfort for five weeks.",null,[25,29],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"BEHAVIORAL","The web-based mind-body intervention with HRVB contains the following components: 1) Breathing training with HRV biofeedback; 2) 5 different topics will be included ; 3) Home exercise of slow breathing and mindfulness exercise.",[9],{"type":26,"name":15,"description":30,"armGroupLabels":31,"otherNames":23},"The web-based mind-body intervention will receive 5 different topics courses.",[15],[33],{"name":34,"affiliation":5,"role":35},"Shu-Yu Kuo, Phd","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","+886-2-2736-1661","6301","sykuo@tmu.edu.tw",[43],{"facility":44,"status":45,"city":46,"state":23,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Infertility clinic","RECRUITING","Taipei","110","Taiwan","TW",{"type":51,"coordinates":52},"Point",[53,54],121.52639,25.05306,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":23,"phoneExt":23,"email":23},"Jin-Ru Chang, BS",{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Shu Yu Kuo","Principal investigator","100426198","trajectory-of-psychological-distress-among-infertility-women-100426198",false,"NCT04829877","Trajectory of Psychological Distress Among Infertility Women","Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback","Inclusion Criteria:\n\n* 20-year-old and above\n* Seeking infertility care\n* Contemplating pregnancy\n* Intended to start their ART cycle\n* Able to speak Taiwanese or Mandarin\n\nExclusion Criteria:\n\n* Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia\n* Already had started their ART treatment\n* Taking medications that might affect ANS activity",true,"FEMALE","20 Years","60 Years",{"count":74,"type":75},750,"ESTIMATED","INTERVENTIONAL",[78],"NA","Background: Infertility is a serious reproductive health issue and affects 48.5 million couples worldwide. Women undergoing fertility treatment often experienced psychological distress but also social stigma that is close linked to later pregnancy outcome. Despite the advancement in assisted reproductive technology, effective interventions for reducing stress, anxiety, and depressive symptoms for infertility women remain lacking.\n\nObjectives: The objective of this proposal is to evaluate the efficacy of web-based mind-body intervention combining HRV biofeedback on the infertility women's anxiety symptoms, levels of depression, HRV function, mindful awareness, infertility self-efficacy, and pregnancy rates.\n\nMethods: We plan to conduct a randomized controlled trial on the web-based mind-body intervention combining heart rate variability biofeedback. Eligible women will be recruited and randomized into three groups. Intention-to-treat analysis and mixed regression modeling will be used to estimate the effectiveness of the interventions.\n\nAnticipatory results: Effective strategies will be determined for infertility women.",[81,82,83],"Infertility","Heart Rate Variability","Biofeedback",[85,86,87,88,89],"infertility","mind-body intervention","heart rate variability","biofeedback","psychological distress","2025-01-24",{"date":92,"type":93},"2025-01-27","ACTUAL",{"date":95,"type":93},"2022-04-19",{"date":97,"type":75},"2025-04",{"name":5,"class":6},1]