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

NCT05167331 | Terminated

• 1 other identifier: 8113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Anxiety

Keywords

virtual reality; hypnosis; nitrous oxide; dental anxiety; child

Outcome Measures

Primary Outcomes (1)

• Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale)

  Child behavior can be assessed using the Veerkamp Modified Venham Scale (VMS). This is a scale from 0 (completely calm and relaxed patient) to 5 (distressed patient, completely disconnected). Several parameters are taken into account in this scale such as: the child's movements, crying or screaming, the possibility or not of performing the treatment. The authors have found this scale to be a reliable, easy-to-use and reproducible instrument when it comes to assessing children's behavior. This outcome measure is assessed by an external examinator with the video recording the procedures.

  5 weeks

Secondary Outcomes (3)

• Assessment of analgesia with VR

  5 weeks

• Assessment of children's tolerance levels to VR and pharmacological technique.

  5 weeks

• Assessment of the impact of the child's temperament on his acceptance of nitrous oxide and RV sedations using a questionnaire and a temperament scale

  The parents answer to the questionnaire on the first visit during inclusion.

Study Arms (2)

Virtual Reality

ACTIVE COMPARATOR

* (T1) after fitting the headset to the child's face, the assistant starts the VR program chosen by the child. * (T2) Five minutes after induction, local anesthesia with the QUICKSLEEPER device is performed. The injection of a cartridge of anesthetic Articaïne SEPTANEST 1/200 000 is administered intraosseously. * (T3) After placing the rubber dam, the investigator performs restorative +/- endodontic care of the selected temporary molar. * (T4) Once the treatment is finished, the sedation is stopped and the patient rests in the chair for 5 minutes. * (T5) As soon as the investigator considers that the child is back to normal state, he can leave the office with his parents.

Device: Dispositif de RV - HYPNO VR

Nitrous oxide sedation

ACTIVE COMPARATOR

* (T1) With the nitrous oxide/oxygen inhalation system titrated to 50%/50% whose flow rate is adapted to the child's respiratory flow. The assistant is responsible for controlling the sedation. Verbal encouragement is always present to reassure the child. * (T2) Five minutes after induction, local anesthesia with the QUICKSLEEPER device is performed. The injection of a cartridge of anesthetic Articaïne SEPTANEST 1/200 000 is administered intraosseously. * (T3) After placing the rubber dam, the investigator performs restorative +/- endodontic care of the selected temporary molar. * (T4) Once the treatment is finished, the sedation is stopped and the patient rests in the chair for 5 minutes. * (T5) As soon as the investigator considers that the child is back to normal state, he can leave the office with his parents.

Drug: Nitrous Oxide inhalation

Interventions

Nitrous Oxide inhalation DRUG

use of Nitrous Oxide inhalation on children's anxiety during a dental treatment

Nitrous oxide sedation

Dispositif de RV - HYPNO VR DEVICE

use of Virtual Reality on children's anxiety during a dental treatment

Virtual Reality

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 7 and 10 years
• With an indication for conservative and/or endodontic care of at least 2 temporary molars belonging to the same dental arch, unilateral or bilateral, and equivalent in terms of caries and symptoms
• With dental anxiety
• ASA I patients

You may not qualify if:

• Patient with a history of MEOPA or virtual reality sedation for dental treatment
• Patient refusing to do preoperative intra-oral x-rays
• Patient with one of the MEOPA contraindications
• Patient with a history of post-operative nausea vomiting or motion sickness
• Patient with visual or hearing disorders
• Patient presenting with a psychiatric pathology or having taken psychotropic drugs in the 8 weeks preceding the 1st visit and during the duration of the study
• Patient with claustrophobia
• Patient without French Social Security coverage
• Lack of consent from the holders of parental authority to participate in the study

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• Do NM, Maniere MC, Lefebvre F, Clauss F. 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. Trials. 2025 Jun 9;26(1):201. doi: 10.1186/s13063-025-08849-z.

  PMID: 40490788 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 22, 2021
• Study Start: February 10, 2022
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: June 8, 2026

Record last verified: 2026-02

Locations

FR (1)