NCT05167331

Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie

Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

The vicious circle of dental anxiety impacts major aspects of a child's quality of life. Hypnosis using distraction is one of the most common non-pharmalogical techniques in behavior and pain management in pediatric dentistry. Its value over traditional pharmalogical sedation is undeniable. This clinical study examines the application of hypnosis delivered through immersive virtual reality (VR) for anxious children ongoing dental procedures. The investigators will explore whether VR is as effective on pain and anxiety relief as a pharmacological sedation with inhalation of nitrous oxide.

Detailed description

The working hypothesis of this study is that hypnosis through virtual reality can reduce children's anxiety as well as their pain level during dental care with an efficiency and tolerance at least similar to nitrous oxide inhalation. Specifically, the statistical analyses will be based on an assumption of non-inferiority of VR compared to the pharmacological technique of nitrous oxide sedation. Each patient (aged from 6 to 10) attended for two visits in order to benefit of 2 similar conservative dental treatments on primary molars. Everyone was randomly allocated to receive hypnosis through virtual reality or nitrous oxide/oxygen titrated to 50%/50% at the first visit, the alternative being used at the second visit. This randomization helps avoid any experimental bias related to a first positive or negative experience, each patient being its own control. Vital signs and a video of the child's behavior are recorded for an external examinator. The video shows the child's body response as an indicator for his anxiety level through the procedures. The child's face doesn't appear on the video in order to reduce risks of bias.

Conditions

• Dental Anxiety

Interventions

Type	Name	Description
DRUG	Nitrous Oxide inhalation	use of Nitrous Oxide inhalation on children's anxiety during a dental treatment
DEVICE	Dispositif de RV - HYPNO VR	use of Virtual Reality on children's anxiety during a dental treatment

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-02-01
• Completion: 2023-03-01
• First posted: 2021-12-22
• Last updated: 2022-02-17

Locations

1 site across 1 country: France