[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07288047":3,"trial-entities:NCT07288047":117,"trial-summary:NCT07288047":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":25,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":51,"secondary_outcomes":59,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":85,"locations":88,"central_contacts":109,"overall_officials":111,"references":115,"see_also_links":116},"NCT07288047","STUDY25090152","Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion","Virtual Reality as an Adjunctive Agent for the Management of Pain and Anxiety During First Trimester Procedural Abortion: a Randomized Controlled Trial","RECRUITING","2026-10-30","2026-05","2026-05-06","2026-05-01","Study Investigator","OTHER",false,"The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.","While procedural abortions are common outpatient procedures, providing optimal pain and anxiety relief during these procedures is challenging. With rapidly developing technological advances, virtual reality (VR) has emerged as a promising modality to help manage pain and anxiety control in the medical field, including obstetrics and gynecology. However, there are no studies evaluating the effect of VR on pain during a procedural abortion.\n\nThe goal of this randomized controlled trial is to primarily evaluate whether using a VR headset to display a meditative nature video as a noninvasive, low risk technology may reduce pain and anxiety for patients undergoing a first trimester procedural abortion in an outpatient setting. Investigators will also evaluate factors influencing satisfaction with the procedure. Investigators will compare use of the VR headset with usual care, to usual care only; for a first trimester procedural abortion, usual care includes oral pain medications, local anesthetic medication in the cervix, and verbal reassurance. Participants will be asked to complete a survey before, after, and one week following the procedure to assess pain, anxiety, and overall satisfaction.",[19,20,21,22,23,24],"Abortion, First Trimester","Pain Management","Pain After Surgery","Satisfaction","Satisfaction With Care","Anxiety After Surgery",[26,27,28,29,30],"satisfaction","virtual reality","procedural abortion","pain control","anxiety control","INTERVENTIONAL","SUPPORTIVE_CARE",[34],"NA",{"count":36,"type":37},72,"ESTIMATED",[39,44],{"type":40,"name":41,"description":42,"armGroupLabels":43},"DEVICE","VR headset","VR Headset: Meta Quest 3S Meditative nature videos provided via \"Guided Meditation VR\" app.",[41],{"type":14,"name":45,"description":46,"armGroupLabels":47,"otherNames":49},"Usual Care","Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.",[48,41],"Usual care only",[50],"Routine care",[52,56],{"measure":53,"description":54,"timeFrame":55},"Pain scores during a first trimester procedural abortion","Pain will be measured on a visual analogue scale during and after the procedural abortion via a REDCap survey. The scale is from 0-100, with 0 being \"No pain\" and 100 being the \"Worst pain of my life\". The difference in this score (post-procedure minus pre-procedure) is what will be compared between study arms.","Day of enrollment: immediately preprocedure and 15 minutes postprocedure.",{"measure":57,"description":58,"timeFrame":55},"Anxiety scores during a first trimester procedural abortion","Anxiety will be measured on a visual analogue scale during and after the procedural abortion via a REDCap survey. The scale is from 0-100, with 0 being \"No anxiety or fear\" and 100 being the \"Worst anxiety or fear of my life\". The difference in this score (post-procedure minus pre-procedure) is what will be compared between study arms.",[60],{"measure":61,"description":62,"timeFrame":63},"Satisfaction with the first trimester procedural abortion","Satisfaction will be assessed on a Likert scale using surveys administered on the day of the procedure and one week after the procedure. A score of 1 = very dissatisfied, and a score of 5 = very satisfied.","Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.","FEMALE","18 Years",null,{"inclusion":68,"exclusion":75,"raw_text":84},[69,70,71,72,73,74],"Patients at Planned Parenthood of Western Pennsylvania who have decided to undergo and are eligible for a procedural abortion.","18 years old or older","\\\u003C14 weeks gestation on day of abortion","Able to comprehend written English","Willing to comply with the study protocol","Willing and able to provide informed consent",[76,77,78,79,80,81,82,83],"History of vertigo","History of epilepsy","Claustrophobia","Significant hearing or visual impairments (such as deafness or blindness)","Require hearing aids","Have an implanted medical device, such as cardiac pacemaker or defibrillator","Require misoprostol for cervical preparation","Prior unsuccessful attempt at abortion during this pregnancy","Inclusion Criteria:\n\n* Patients at Planned Parenthood of Western Pennsylvania who have decided to undergo and are eligible for a procedural abortion.\n* 18 years old or older\n* \\\u003C14 weeks gestation on day of abortion\n* Able to comprehend written English\n* Willing to comply with the study protocol\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* History of vertigo\n* History of epilepsy\n* Claustrophobia\n* Significant hearing or visual impairments (such as deafness or blindness)\n* Require hearing aids\n* Have an implanted medical device, such as cardiac pacemaker or defibrillator\n* Require misoprostol for cervical preparation\n* Prior unsuccessful attempt at abortion during this pregnancy",[86,87],"ADULT","OLDER_ADULT",[89,104],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"Center for Family Planning Research, Magee-Womens Hospital","Pittsburgh","Pennsylvania","15213","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Study Coordinator","CONTACT","412-641-5496","fpr@upmc.edu",{"lat":102,"lon":103},40.44062,-79.99589,{"facility":105,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":106,"geoPoint":108},"Planned Parenthood of Western Pennsylvania",[107],{"name":97,"role":98,"phone":99,"email":100},{"lat":102,"lon":103},[110],{"name":97,"role":98,"phone":99,"email":100},[112],{"name":97,"affiliation":113,"role":114},"Univeristy of Pittsburgh","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Abortion Finding",[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This study will involve 72 participants and compares two groups: one receiving usual care and another receiving usual care plus a VR headset. It is a randomized controlled trial, meaning participants are assigned to a group by chance.","completed","Virtual Reality for Pain and Anxiety During First Trimester Abortion","This study is looking at whether using a virtual reality (VR) headset can help reduce pain and anxiety during a first trimester procedural abortion. Researchers will compare patients who receive usual care (like ibuprofen, a numbing shot in the cervix, and verbal reassurance) with those who receive usual care plus a VR headset showing meditative nature videos. The goal is to see if the VR headset can lower pain and anxiety scores and make patients more satisfied with their care. You might be able to join if you are a woman aged 18 or older, are having a first trimester procedural abortion, are less than 14 weeks pregnant, and can understand written English. The study aims to enroll 72 participants.","Participants will be followed for one week after the procedure.",120,"You would complete surveys before, after, and one week following the procedure to assess your pain, anxiety, and overall satisfaction.","Not stated in the trial record.",[41,45],"v2"]