Virtual Reality vs Nitrous Oxide in Pediatric Dentistry

NCT05890898 | Completed

• 1 other identifier: 2023-1000
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Dentistry

Outcome Measures

Primary Outcomes (2)

• Rate of effectiveness virtual reality goggles reduce pain

  To determine whether the use of distraction via virtual reality headset can be as effective as nitrous oxide for purposes of anxiolysis and analgesia during dental treatment. The FLACC scale will be used to help measure this outcome. Patients will be observed during injection and assessed by the operator using the Faces, Legs, Arms, Crying Consolability (FLACC) scale. Each category will be rated from 0 to 2. Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in movements or unable to console/comfort.

  12 months

• Rate of effectiveness virtual reality goggles reduce pain

  To determine whether the use of distraction via virtual reality headset can be as effective as nitrous oxide for purposes of anxiolysis and analgesia during dental treatment. The WongBaker scale will be used to help measure this outcome. Patients will rate their pain using the Wong-Baker FACES Pain Scale by indicating which face best depicts the pain they are experiencing. Each face has a corresponding number: 0 = doesn't hurt at all to 10 = hurts as much as you can imagine.

  12 months

Secondary Outcomes (1)

• Rate of effectiveness of virtual reality distraction to nitrous oxide

  12 months

Study Arms (2)

Control: Nitrous Oxide, then Virtual Reality Goggles

EXPERIMENTAL

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.

Behavioral: Virtual Reality Headset; Drug: Nitrous Oxide

Treatment: Virtual Reality Goggles, then Nitrous Oxide

EXPERIMENTAL

The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit under N2O will be used instead of VR.

Behavioral: Virtual Reality Headset; Drug: Nitrous Oxide

Interventions

Virtual Reality Headset BEHAVIORAL

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.

Control: Nitrous Oxide, then Virtual Reality Goggles; Treatment: Virtual Reality Goggles, then Nitrous Oxide

Nitrous Oxide DRUG

Nitrous Oxide is the current standard of care being used and will be compared to the use of the VR headsets.

Control: Nitrous Oxide, then Virtual Reality Goggles; Treatment: Virtual Reality Goggles, then Nitrous Oxide

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Interventions

Nitrous Oxide

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 6, 2023
• Study Start: September 19, 2023
• Primary Completion: July 5, 2024
• Study Completion: November 20, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)