Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Virtual Reality: An Interventional Study Comparing the Use of Virtual Reality to Nitrous Oxide for Analgesia During Dental Procedures on Pediatric Patients

ID
Name
2023-1000
Description
Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study. Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit where N2O will be used instead of VR. Procedures performed in all groups will be restorative treatments, which can include intraoral anesthetic injections, placing dental fillings, crowns, and the extractions of teeth. In group 1, A specific VR headset, the "Oculus Quest 2" will be used. Through the headset, a video will be played for the child during a dental procedure.
Trial arms
Trial start
2023-09-19
Estimated PCD
2024-09-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Virtual Reality Headset
To determine if virtual reality headsets can reduce a patients pain level instead of using the standard Nitrous. This may provide a alternate to patients who cannot receive nitrous if pain or anxiety can be reduced effectively.
Arms:
Control: Nitrous Oxide, then Virtual Reality Goggles, Treatment: Virtual Reality Goggles, then Nitrous Oxide
Nitrous Oxide
Nitrous Oxide is the current standard of care being used and will be compared to the use of the VR headsets.
Arms:
Control: Nitrous Oxide, then Virtual Reality Goggles, Treatment: Virtual Reality Goggles, then Nitrous Oxide
Size
62
Primary endpoint
Rate of effectiveness virtual reality goggles reduce pain
12 months
Rate of effectiveness virtual reality goggles reduce pain
12 months
Eligibility criteria
Inclusion Criteria: * Male or female pediatric dental patients age 4-12 years * Require two restorative procedures that includes injection of anesthesia * American Society of Anesthesiologists (ASA) physical status classification 1 or 2 Exclusion Criteria: * Have health issues that prevent use of VR Oculus headset, * Hypersensitivity to audio-visual devices that can lead to seizures * ASA physical status classification 3 or 4
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}
Updated at
2023-10-03

1 organization

1 product

1 indication

Organization
Geisinger Clinic
Product
Nitrous Oxide
Indication
Pediatric Dentistry