[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638584":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":68,"collaborators":28,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":28,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":28,"enrollmentInfo":80,"targetDuration":28,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":28,"overallStatus":91,"whyStopped":28,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Miami","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality Relaxation Group","EXPERIMENTAL","Participants assigned to this arm will complete one relaxation session during a single cardiology clinic visit. The session will last approximately 8-12 minutes, with one-time exposure only. Total participation time is approximately 30 minutes",[13],"Behavioral: Virtual Reality Relaxation",{"label":15,"type":10,"description":16,"interventionNames":17},"Video Meditation Group","Participants assigned to this arm will complete one guided meditation session during a single cardiology clinic visit. The session will last approximately 8-12 minutes, with a one-time exposure. Total participation time is approximately 30 minutes",[18],"Behavioral: Video Meditation",{"label":20,"type":10,"description":21,"interventionNames":22},"Live Guided Relaxation Group","Participants assigned to this arm will complete one live relaxation session during a single clinic visit. The session lasts approximately 8-12 minutes, with one-time exposure only. Total participation time is approximately 30 minutes.",[23],"Behavioral: Live Guided",{"label":25,"type":26,"description":27,"interventionNames":28},"Quiet Waiting Group","NO_INTERVENTION","Participants assigned to this arm will remain seated quietly in the clinic room without exposure to any active intervention during a single clinic visit. Total participation time is approximately 30 minutes.",null,[30,35,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"BEHAVIORAL","Virtual Reality Relaxation","Participants will wear a virtual reality headset delivering a guided relaxation experience. The VR program includes: immersive visual environments designed to induce calmness, binaural audio beats engineered to promote relaxation, and photic (light) stimulation synchronized with audio and breath cues. The intervention is designed to support autonomic down-regulation and enhance the participant's relaxation response.",[9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":28},"Video Meditation","Participants will view a guided meditation video displayed on a screen. The video includes: soothing visual imagery, gentle narration guiding breath and awareness, calming background music. This intervention is intended to facilitate psychological relaxation through traditional audiovisual meditation techniques.",[15],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"Live Guided","Participants will receive a live, instructor-led relaxation session conducted by a trained study team member. The facilitator will guide the participant through: controlled breathing exercises, progressive muscle relaxation, calming verbal prompts, and mindfulness-based awareness techniques. The goal is to induce relaxation through direct interpersonal guidance.",[20],[44],{"name":45,"affiliation":5,"role":46},"Claudia Martinez, MD","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},"Priscilla Valls","CONTACT","3052438937","ptv7@med.miami.edu",[54],{"facility":5,"status":28,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Miami","Florida","33136","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-80.19366,25.77427,{"lat":64,"lon":63},[67],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},{"type":46,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Claudia Martinez","Professor of Clinical Medicine","100638584","consciousness-studies-and-cardiovascular-health-100638584",false,"NCT07620639","Consciousness Studies and Cardiovascular Health","Inclusion Criteria:\n\n* Age 18 and older\n* Able to provide informed consent (English only for pilot)\n* Chronic Selective Serotonin Reuptake Inhibitors\u002F Serotonin-norepinephrine reuptake inhibitors (SSRI\u002FSNRI) or Attention Deficit\u002F Hyperactivity Disorder (ADHD) meds allowed (recorded)\n* Normal vision and hearing\n* Stable vitals (HR 55-100 bpm, Systolic Blood Pressure (SBP) 90-160mmHg (millimeters of mercury, afebrile)\n* Willing to abstain 6 hours pre-session from caffeine, nicotine, heavy exercise\n* Willing to tolerate electroencephalogram (EEG) headband, Galvanic Skin Response (GSR) electrodes are small sensors placed on the skin (usually fingers or palm) and virtual reality (VR) headset\n\nExclusion Criteria:\n\n* History of seizure disorder or photosensitive epilepsy\n* Migraine with visual aura\n* Retinal disease sensitive to flicker\n* Unstable cardiac disease\n* Dysautonomia\n* Recent sedative use (benzodiazepines, opioids)\n* Beta blocker dose changes within last 7 days\n* Alcohol or recreational drugs within 12 hours\n* Active panic disorder\n* Severe motion sickness\n* Scalp conditions preventing EEG contact\n* Severe visual or hearing impairment Cognitive impairment\n* Non-English speakers (pilot in English only)",true,"ALL","18 Years",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85],"NA","The objective of the study is to evaluate whether a virtual reality (VR) based intervention combining binaural beats, photic stimulation, and real-time biofeedback reduces stress and improves physiological markers compared to non-VR interventions and usual care in patients that go to cardiology clinic.",[88,89,90],"Blood Pressure","Relaxation","Virtual Reality","NOT_YET_RECRUITING","2026-05-26",{"date":94,"type":95},"2026-06-02","ACTUAL",{"date":97,"type":82},"2026-10",{"date":99,"type":82},"2028-10",{"name":5,"class":6},1]