Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-06 @ 12:11 PM
Study NCT ID:
NCT06513260
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Dental Anxiety Scale Scores', 'timeFrame': 'Baseline', 'description': 'In patients with and without the use of virtual reality glasses, the dental anxiety scale and verbal rating scales evaluating their experience during the treatment will be applied.'}, {'measure': 'Heart rate measurements', 'timeFrame': 'During the operation', 'description': 'In patients with and without the use of virtual reality glasses, heart rate will be monitored before, during, and after the treatment.'}, {'measure': 'Blood pressure measurements', 'timeFrame': 'During the operation', 'description': 'In patients with and without the use of virtual reality glasses, blood pressure will be monitored before, during, and after the treatment.'}, {'measure': 'Oxygen saturation measurements', 'timeFrame': 'During the operation', 'description': 'In patients with and without the use of virtual reality glasses, saturation will be monitored before, during, and after the treatment.'}], 'secondaryOutcomes': [{'measure': 'Dentist feedback', 'timeFrame': 'Baseline', 'description': 'Verbal rating scales will be applied to the dentist to evaluate the potential difficulties associated with the use of virtual reality distraction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Anxiety', 'Impact Molar', 'Virtual Reality'], 'conditions': ['Dental Anxiety', 'Impact Molar', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.The main questions it aims to answer are:\n\n* Is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety?\n* Evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores.\n* Does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure?\n\nPatients will undergo anxiety tests before surgery.\n\nPre-operative vital signs will be recorded.\n\nThe procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups.\n\nPost-operative vital signs will be recorded.\n\nAt the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\- Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old\n* Being systemically healthy\n* Needing surgical extraction treatment of impacted lower third molar (in mesioangular position according to Tetsch and Wagner Classification)\n* Having a score of 11 or higher on the dental anxiety scale\n\nExclusion Criteria:\n\n* History of seizures or convulsive disorders\n* Balance disorders such as nystagmus or vertigo\n* Use of psychotropic medications\n* Undergoing treatment for anxiety\n* Patients with psychiatric disorders\n* Presence of dermatological lesions, especially around the face and eyes\n* Presence of any lesion in the eye that would prevent the use of virtual reality\n* Presence of systemic diseases and medication use contraindicating surgical extraction of impacted teeth'}, 'identificationModule': {'nctId': 'NCT06513260', 'briefTitle': 'Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Evaluation of the Effect of Virtual Reality Distraction on Controlling Dental Anxiety During the Surgical Extraction of Impacted Lower Third Molar Teeth', 'orgStudyIdInfo': {'id': 'KutahyaHSU/Edaİzgi/001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Virtual reality application', 'description': 'Application of virtual reality glasses during surgical extraction of impacted lower third molars.', 'interventionNames': ['Procedure: Surgical extraction of impacted lower third molars.']}, {'label': 'No application', 'description': 'No application of virtual reality glasses during surgical extraction of impacted lower third molars.', 'interventionNames': ['Procedure: Surgical extraction of impacted lower third molars.']}], 'interventions': [{'name': 'Surgical extraction of impacted lower third molars.', 'type': 'PROCEDURE', 'description': 'Surgical extraction of impacted mandibular third molars in the mesioangular position, according to the Tetsch and Wagner classification', 'armGroupLabels': ['No application', 'Virtual reality application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43020', 'city': 'Kütahya', 'country': 'Turkey (Türkiye)', 'facility': 'Kütahya Health Science University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'overallOfficials': [{'name': 'Eda İzgi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kutahya University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Doctor', 'investigatorFullName': 'EDA İZGİ', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}