[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07122843":3,"trial-entities:NCT07122843":95,"trial-summary:NCT07122843":100},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":67,"locations":70,"central_contacts":89,"overall_officials":91,"references":93,"see_also_links":94},"NCT07122843","STUDY00004263","VR AI Meditation for Pain","Real Time Guided Meditations for Pain in Virtual Reality Study","RECRUITING","2027-01-20","2025-09","2025-11-26","2025-11-06","Christopher Almario","OTHER",false,"This study aims to assess changes in pain and anxiety as reported by the Pain Numeric Rating Scale (PNRS) and the State-Trait Anxiety Inventory 6 (STAI-6), pre and post a guided meditation in Virtual reality. Objectives of the study are also to determine the feasibility, and patient acceptance of utilizing a LLM-generated guided meditation in VR. Our goal is to learn about any limitations of our approach and provide a pathway for future improvements in creating a VR AI therapist that is optimally aligned with the needs of users.","38 individuals who are admitted to CSMC, who have completed Inpatient Pain Service Center intake form, and who have a baseline pain score of 4 on the PNRS or greater to experience VR guided meditation will be invited to join the study. Patients must have a minimum baseline pain score of 4 or higher on the PNRS to be eligible for evaluation in this study because if a patient begins with no or minimal pain, there is no opportunity for the VR meditation program to produce a measurable reduction in pain levels. Patients will wear a VR headset for approximately 15 minutes. The headset fully covers the eyes, immersing users in a calming, 3D virtual environment. Once the headset is on, patients will engage in a guided meditation experience, set in a nature-themed scene of their choice; options include a lake, beach, mountains, desert, forest, space, and more. An AI-powered guide will lead the meditation, offering real-time, personalized support based on the patient's age and the pain-related information provided during the hospital intake process. The AI is designed to promote relaxation by helping patients focus, breathe deeply, and feel more at ease. The intervention will be standardized for all participants, with each receiving the same duration of exposure in the VR headset and access to an identical selection of nature scenes. Participants will complete pre-intervention pain and anxiety surveys which will take 5-10 minutes followed by a 15-minute experience in VR and we will end with a post-intervention pain (PNRS) and anxiety (STAI-6) surveys (5-10 minutes). The total session will range from 25-35 minutes in length. The study is also determine the feasibility, and patient acceptance of utilizing a LLM-generated guided meditation in VR. The goal is to learn about any limitations of our approach and provide a pathway for future improvements in creating a VR AI therapist that is optimally aligned with the needs of users.",[19],"Pain and Anxiety",[21,22,23],"Virtual Reality","Meditation","Guided Meditation","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},38,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","VR Guided Meditation","Patients will wear a VR headset for approximately 15 minutes. The headset fully covers the eyes, immersing users in a calming, 3D virtual environment. Once the headset is on, patients will engage in a guided meditation experience, set in a nature-themed scene of their choice; options include a lake, beach, mountains, desert, forest, space, and more. An AI-powered guide will lead the meditation, offering real-time, personalized support based on the patient's age and the pain-related information provided during the hospital intake process. The AI is designed to promote relaxation by helping patients focus, breathe deeply, and feel more at ease. The intervention will be standardized for all participants, with each receiving the same duration of exposure in the VR headset and access to an identical selection of nature scenes. The patients will fill our pre and post intervention pain and anxiety surveys. The pre and post surveys will take between 5-10 minutes each to complete.",[34],[38],{"measure":39,"description":40,"timeFrame":41},"Pain Numeric Rating Scale Pre and Post VR Guided Meditation","To evaluate impact to pain levels after VR guided meditation (1 time). We will use a validated pain survey and look at Pain Numeric Rating Scale (pre compared to post-VR).","Pre VR Use (Baseline) and Post VR Use (after a 15 minutes experience in VR)",[43],{"measure":44,"description":45,"timeFrame":46},"STAI-6 Scores Pre and Post VR Guided Meditation","To evaluate anxiety scores pre and post VR guided meditation on the STAI-6.","Pre VR use (Baseline) and Post VR use (after 15-minute experience in VR)","ALL","18 Years",null,{"inclusion":51,"exclusion":56,"raw_text":66},[52,53,54,55],"18+ years of age","Individuals who are admitted to CSMC and who have completed the Inpatient Pain Service Center intake form.","Participants must speak one of the program's supported languages (currently English and Spanish)","Minimum pain score of 4 out 10 on baseline pain survey",[57,58,59,60,61,62,63,64,65],"Unwilling and\u002For unable to participate","Does not understand English or Spanish","Self-reported history of severe motion sickness","The presence of a facial\u002Fhead deformity that will prohibit the wearing of a VR HMD","Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses","Legally deaf","Having had a seizure in the past year","Unable to understand the instructions or to consent to participation in the study","Those who are pregnant","Inclusion Criteria:\n\n* 18+ years of age\n* Individuals who are admitted to CSMC and who have completed the Inpatient Pain Service Center intake form.\n* Participants must speak one of the program's supported languages (currently English and Spanish)\n* Minimum pain score of 4 out 10 on baseline pain survey\n\nExclusion Criteria:\n\n* Unwilling and\u002For unable to participate\n* Does not understand English or Spanish\n* Self-reported history of severe motion sickness\n* The presence of a facial\u002Fhead deformity that will prohibit the wearing of a VR HMD\n* Those that require corrective lenses -2.5 or stronger that cannot be corrected with contact lenses\n* Legally deaf\n* Having had a seizure in the past year\n* Unable to understand the instructions or to consent to participation in the study\n* Those who are pregnant",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":86},"Cedars-Sinai Medical Center","Los Angeles","California","90048","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Ella F Tetrault, BS","CONTACT","4243151311","ella.tetrault@cshs.org",{"name":84,"role":85},"Christopher V Almario, MD, MSHPM","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},34.05223,-118.24368,[90],{"name":79,"role":80,"phone":81,"email":82},[92],{"name":84,"affiliation":72,"role":85},[],[],{"nct_id":4,"conditions":96,"biomarkers":99},[97,98],"Anxiety","Pain",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study with a planned enrollment of 38 participants. It is a single-arm study, meaning all participants will receive the VR Guided Meditation intervention.","completed","VR AI Meditation for Pain and Anxiety","This study is testing if VR Guided Meditation can help reduce pain and anxiety. You would wear a special headset for about 15 minutes that puts you in a calming, 3D nature scene. An AI (Artificial Intelligence) guide will lead you through a meditation based on your age and pain information. Researchers want to see if your pain and anxiety scores improve after using the VR meditation. They also want to understand how well people accept this new approach and find ways to make it better. The study is looking for 38 participants who are admitted to CSMC (Cedars-Sinai Medical Center) and have a pain score of 4 or higher out of 10.","Your pain and anxiety levels are measured immediately before and after the 15-minute VR experience.",113,"You would wear a VR headset for approximately 15 minutes for a guided meditation experience. Your pain and anxiety levels will be measured before and after this 15-minute session.","Not stated in the trial record.",[34],"v2"]