Virtual Reality and Anxiety in Pediatric Dentistry

NCT04886141 | Completed

• 1 other identifier: 2021-0138
• Study Type: interventional
• Target: 53
• 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. The treatment group will receive dental treatment while wearing Virtual reality Headset. Control group will receive the standard of care dental treatment with under nitrous sedation. 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 (1)

• Rate of effectiveness virtual reality goggles reduce pain

  To determine if pain can be diminished or alleviated and if subjects had better cooperation or pain tolerance with the distraction through virtual reality headsets.

  12 months

Secondary Outcomes (1)

• Rate of effectiveness of virtual reality distraction to nitrous oxide

  12 months

Study Arms (2)

Standard of Care treatment with Scales

NO INTERVENTION

Patients will receive the standard of care restorative procedure with the addition of the FLACC pain scale, Wong Baker FACES Pain rating and Houpt scale to create a baseline data of pain to compare with the experimental group.

Virtual Reality Headset

EXPERIMENTAL

Instead of receiving the Nitrous that would be used to help calm patients during the standard of care restorative procedure. Patients will be given a the Oculus Quest 2 Virtual realty headset and a video will be played. The FLACC pain scale, Wong Baker FACES Pain rating and Houpt scale data will be collected to compare the patients pain level between the two groups.

Behavioral: Virtual Reality Headset

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.

Virtual Reality Headset

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 a restorative procedure that includes injection of anesthesia .
• Exhibiting behavior Frankel 2 or 3 during their new patient, recall or previous dental appointment.
• ASA 1 or 1

You may not qualify if:

• Children who exhibit behavior rated as Frankl 1, or Frankl 4.
• Have health issues that prevent use of VR Oculus headset,
• Hypersensitivity to audio-visual devices that can lead to seizures
• ASA 3 or 4

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentist

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 13, 2021
• Study Start: October 21, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 21, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

US (1)