Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 12:04 PM
Study NCT ID:
NCT06964451
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014081', 'term': 'Tooth Extraction'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Face Scale', 'timeFrame': '1 day', 'description': 'We used the Wong-Baker Face Scale to assess pain, which allows patients to visually describe their level of pain. This scale consists of six faces with different expressions, ranging from a face showing no pain to a face representing the worst possible pain. This method of assessment is particularly useful for children. Pain was recorded during the administration of anaesthesia and during the tooth extraction procedure'}, {'measure': 'Heart rate', 'timeFrame': '1 day', 'description': "Additionally, heart rate was monitored to assess the patient's physiological response to stress and pain during the procedure. Heart rate was recorded during anaesthesia administration and during the procedure using a smartwatch that allows continuous heart rate tracking (Samsung Galaxy Watch). This type of measurement provides additional information on how the patient responds to pain and stress, enabling the dentist to adjust their approach according to the patient's physiological response."}], 'secondaryOutcomes': [{'measure': 'Satisfaction questionnaire', 'timeFrame': '1 day', 'description': 'After the extraction procedure with VR application, patients filled out a modified satisfaction questionnaire. Responses were classified based on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, and 5 = strongly agree. The post-clinical questionnaire included questions related to reduction of fear of anaesthesia and extraction, effectiveness of VR in diverting attention from the procedure, experience of discomfort during the procedure, enjoyment of the VR experience, and the potential of VR in overcoming fear of other procedures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'distraction', 'gamification', 'tooth extraction', 'MIH'], 'conditions': ['Virtual Reality', 'Distraction', 'Gamification', 'Tooth Extraction']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.', 'detailedDescription': "Dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. To alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. One innovative method of distraction is gamification, which involves the use of Virtual Reality (VR) to redirect patients' focus to something relaxing instead of the treatment itself. The aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (MIH) affected lower first molars under local anaesthesia. In prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. Through VR goggles, patients were immersed in a virtual video game world to distract them from the dental procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for the extraction of both lower first molars due MIH grade 4.\n\nExclusion Criteria:\n\n* Exclusion criteria for the study encompassed individuals with systemic disease, special needs, patients with a history of epileptic seizures or episodes of dizziness, as well as patients suffering from claustrophobia.'}, 'identificationModule': {'nctId': 'NCT06964451', 'acronym': 'VRGAMIFICATION', 'briefTitle': 'Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Kragujevac'}, 'officialTitle': 'Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients', 'orgStudyIdInfo': {'id': '01-14788/2022'}, 'secondaryIdInfos': [{'id': 'Ethics Committee', 'type': 'OTHER', 'domain': 'Faculty of Medical Sciences University of Kragujevac, Serbia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NON VR', 'description': 'In the extraction of one tooth, the procedure was performed according to the standard protocol (Non VR Phase).', 'interventionNames': ['Procedure: Extraction tooth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VR', 'description': 'For the tooth on the opposite side, the entire extraction procedure (including the application of local anesthesia) was conducted using a gamification model with VR goggles (VR Gamification Phase)', 'interventionNames': ['Procedure: Extraction tooth']}], 'interventions': [{'name': 'Extraction tooth', 'type': 'PROCEDURE', 'description': 'Extraction of MIH Grade 4 molar', 'armGroupLabels': ['NON VR', 'VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'Faculty od Medical Sciences University of Kragujevac', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rasa Mladenovic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor, Pediatric dentist', 'investigatorFullName': 'Rasa Mladenovic', 'investigatorAffiliation': 'University of Kragujevac'}}}}