Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-25 @ 3:16 PM
Study NCT ID:
NCT07273968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety reduction (MDAS questionnaire)', 'timeFrame': 'Day 1', 'description': '5-item validated scale, score range 5-25'}, {'measure': 'Anxiety reduction (MDAS questionnaire)', 'timeFrame': 'Month1', 'description': '5-item validated scale, score range 5-25'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Anxiety', 'Third Molar Extraction', 'Oral Surgery']}, 'descriptionModule': {'briefSummary': 'Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 18-65\n* Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth\n* ASA I-II\n* Written informed consent.\n\nExclusion criteria:\n\n* Visual/hearing impairment\n* Psychiatric disorders or psychotropics (\\<8 weeks)\n* Claustrophobia\n* Heavy smoking \\>10 cig/day\n* Previous radiotherapy (jaw)\n* ASA III-IV\n* Pregnancy\n* Antithrombotic therapy\n* Chemotherapy\n* Bisphosphonates\n* Uncontrolled diabetes\n* Severe anxiety requiring GA or pharmacological sedation\n* No health insurance affiliation.'}, 'identificationModule': {'nctId': 'NCT07273968', 'acronym': 'SEREIN', 'briefTitle': "Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Clinical Study Evaluating the Effect of Virtual Reality on Reducing Anxiety in Patients Undergoing Wisdom Teeth Extraction', 'orgStudyIdInfo': {'id': '9832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group', 'description': 'Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system).', 'interventionNames': ['Device: Virtual reality HypnoVR® (VR headset + hypnotic software)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (No VR)', 'description': 'Wisdom tooth extraction under local anesthesia alone (no VR).', 'interventionNames': ['Other: Control Group (No VR)']}], 'interventions': [{'name': 'Virtual reality HypnoVR® (VR headset + hypnotic software)', 'type': 'DEVICE', 'description': 'CE-marked class I device combining VR immersion with hypnotic text and music therapy to reduce anxiety and pain during oral surgery.', 'armGroupLabels': ['Virtual Reality Group']}, {'name': 'Control Group (No VR)', 'type': 'OTHER', 'description': 'local anesthesia alone (no VR)', 'armGroupLabels': ['Control Group (No VR)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}