Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie
HYPNOSEDENT
Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial
1 other identifier
interventional
30
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2021
CompletedFirst Posted
Study publicly available on registry
December 22, 2021
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFebruary 17, 2022
February 1, 2022
Same day
November 25, 2021
February 1, 2022
Conditions
Keywords
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.
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.
Interventions
use of Nitrous Oxide inhalation on children's anxiety during a dental treatment
use of Virtual Reality on children's anxiety during a dental treatment
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091, France
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: 40490788DERIVED
Central Study Contacts
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 1, 2022
Primary Completion
February 1, 2022
Study Completion
March 1, 2023
Last Updated
February 17, 2022
Record last verified: 2022-02