[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06349564":3,"trial-entities:NCT06349564":115,"trial-summary:NCT06349564":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":44,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":87,"locations":90,"central_contacts":100,"overall_officials":110,"references":113,"see_also_links":114},"NCT06349564","23-01443","Implementing Virtual Reality (VR) to Reduce Sedation","Pilot Proof of Concept Study for Implementing Virtual Reality (VR) to Reduce Sedation Requirement During Endoscopy","RECRUITING","2026-09","2026-03","2026-03-19","2024-12-09","NYU Langone Health","OTHER",true,"The study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. Patients are administered minimal sedation (2 mg of Versed and 25 mg of Fentanyl) and are given Virtual Reality (VR) goggles to wear for the duration of the procedure. The purpose of this study is to assess the feasibility, effect, and safety of using VR goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.",null,[19],"Sedative During Endoscopy",[21,22,23,24,25],"GERD","Dyspepsia","screening colonoscopy","diagnostic upper endoscopy","Gastroesophageal reflux disease","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},10,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DEVICE","Pico 4 Enterprise headset with noise cancelling headphones","The device includes a computer tablet and virtual reality headset.",[39],"Endoscopic Procedure with VR Headset",[41],{"measure":42,"timeFrame":43},"Total amount of sedative drugs administered during the procedure","End of procedure, up to 1 hour",[45,48,50,53,56,58,60],{"measure":46,"timeFrame":47},"Patient-reported discomfort or pain (using 0-10 pain scale)","During PACU stay, approximately 30 minutes",{"measure":49,"timeFrame":43},"Duration of the procedure",{"measure":51,"description":52,"timeFrame":47},"Overall patient satisfaction scores","Using Likert scale of 1-7. Subjects will be asked to rank several variables on the Likert scale, including overall experience (from 1-very dissatisfied to 7-very satisfied), enjoyability (from 1- not enjoyable to 7-very enjoyable), and anxiety (from 1-extreme anxiety to 7-no anxiety). Scores range from 3-21, higher scores indicate satisfaction.",{"measure":54,"description":55,"timeFrame":47},"Number of events of complications from VR","Events such as nausea, vomiting, dizziness.",{"measure":57,"timeFrame":43},"Number of technical failures",{"measure":59,"timeFrame":43},"Troubleshooting time",{"measure":61,"timeFrame":62},"PACU length of stay","End of PACU stay, approximately 30 minutes","ALL","21 Years","65 Years",{"inclusion":67,"exclusion":71,"raw_text":86},[68,69,70,69],"Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital","Aged 21 to 65","Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital",[72,73,74,75,76,77,78,79,80,81,82,83,84,85],"Visual impairments such as blindness which would impair them from watching the entertainment videos.","Patients with history of CAD,","History of seizures,","History of vertigo,","History of allergy to plastic,","ASAII or III,","Patient with active GI bleed, having either melena or hematochezia.","Visual impairments such as blindness which would impair them from watching the entertainment videos","Patients with history of CAD","History of seizures","History of vertigo","History of allergy to plastic","ASAII or III","Patient with active GI bleed, having either melena or hematochezia","INTERVENTION GROUP\n\nInclusion Criteria:\n\n* Undergoing screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital\n* Aged 21 to 65\n\nExclusion Criteria:\n\n* Visual impairments such as blindness which would impair them from watching the entertainment videos.\n* Patients with history of CAD,\n* History of seizures,\n* History of vertigo,\n* History of allergy to plastic,\n* ASAII or III,\n* Patient with active GI bleed, having either melena or hematochezia.\n\nCONTROL GROUP\n\nInclusion Criteria:\n\n* Underwent screening colonoscopy or diagnostic upper endoscopy for GERD or dyspepsia at NYU Langone Brooklyn Hospital\n* Aged 21 to 65\n\nExclusion Criteria:\n\n* Visual impairments such as blindness which would impair them from watching the entertainment videos\n* Patients with history of CAD\n* History of seizures\n* History of vertigo\n* History of allergy to plastic\n* ASAII or III\n* Patient with active GI bleed, having either melena or hematochezia",[88,89],"ADULT","OLDER_ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"geoPoint":97},"NYU Langone Brooklyn","Brooklyn","New York","11220","United States",{"lat":98,"lon":99},40.6501,-73.94958,[101,106],{"name":102,"role":103,"phone":104,"email":105},"Maysaa El Zoghbi, MD","CONTACT","216-835-7626","Maysaa.ElZoghbi@nyulangone.org",{"name":107,"role":103,"phone":108,"email":109},"Gregory Faulx","216-213-7413","gregory.faulx@nyulangone.org",[111],{"name":102,"affiliation":13,"role":112},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":120},[117,22,118,119],"Colonoscopy","Gastroesophageal Reflux Disease","Upper Endoscopy",[],{"nct_id":4,"found":15,"summary":122,"prompt_version":132},{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is a prospective pilot study with 10 participants. All participants will receive minimal sedation and wear VR goggles during their procedure.","completed","Virtual Reality for Sedation During Endoscopy","This study is testing if using a Pico 4 Enterprise virtual reality (VR) headset during endoscopy procedures can help reduce the amount of sedative drugs needed. You might be eligible if you are between 21 and 65 years old and are having a screening colonoscopy or a diagnostic upper endoscopy for GERD (Gastroesophageal Reflux Disease) or dyspepsia at NYU Langone Brooklyn Hospital. The study aims to see if VR can decrease the total amount of sedative drugs like Versed and Fentanyl administered, improve your satisfaction, and shorten recovery time. This is a small pilot study with 10 planned participants, and its current status is unclear.","The total amount of sedative drugs will be measured at the end of the procedure, up to 1 hour.",105,"You would undergo a screening colonoscopy or diagnostic upper endoscopy. You would wear VR goggles during the procedure.","Not stated in the trial record.",[],"v2"]