Efficacy of virtual reality hypnosis versus conscious sedation with nitrous oxide in the management of dental anxiety in pediatric dentistry: protocol for a prospective randomized controlled trial

Abstract

Background: Dental anxiety is defined as a persistent and excessive fear of dental treatment. It often leads to interruptions during procedures and, frequently, avoidance of dental care. For patients over the age of 7, nitrous oxide-oxygen inhaled sedation (NOIS) represents one of the most effective and well-established pharmacological approaches to reducing anxiety and pain during dental treatment. Meanwhile, medical hypnosis offers an interesting non-pharmacological alternative by inducing a hypnotic state, potentially serving as a means of sedation to alleviate anxiety or pain. The advancement of virtual reality (VR) technology makes medical hypnosis more accessible to dental practitioners, yielding promising outcomes. To our knowledge, no clinical trial has evaluated the efficacy of medical hypnosis associated with 3D immersive virtual reality devices for pediatric dental procedures.

Methods: This prospective, controlled, single-blind clinical study including anxious patients aged 7 to 10 years old aims to demonstrate non-inferiority of virtual reality approach. Using a split-mouth design, each patient will attend two separate visits for two comparable conservative dental procedures. At the first procedure, they will randomly be assigned to receive either hypnosis via VR or NOIS. The alternative method will be administered during the second visit. The primary outcome is the sedation success based on the completion of the dental procedure. A score of 3 or higher on the Modified Venham Scale noted more than twice ends the session and qualifies as a sedation failure. The secondary outcomes involve assessing children's tolerance and the temperament influence on sedation success.

Discussion: This study will evaluate the efficacy of a novel non-pharmacological sedation for the management of anxious children in a dental setting. The results may help practitioners choose the appropriate anxiolytic therapeutic option, based on different psychometric and temperament parameters.

Trial registration: ClinicalTrials.gov NCT05167331. Registered on December 22, 2021.

Keywords: Child behavior; Conscious sedation; Dental anxiety; Hypnosis; Nitrous oxide; Virtual reality.

Fig. 1

a Session using virtual reality goggles; b session using EMONO; c videos viewed by the outcome examinator who can be blinded in order to reduce risks of bias

Fig. 2

Schedule of enrolment, interventions, and assessments during the trial

Fig. 3

CONSORT flow diagram of recruitment of subjects, randomization, allocation, completion of local anesthesia administration, and analysis