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Terminated
NCT05167331
Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie
Conditions: Dental Anxiety
Sex: All
Ages: 7 Years – 10 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University Hospital, Strasbourg, France
Location: Les Hôpitaux Universitaires de Strasbourg Strasbourg
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.
Eligibility Criteria
Inclusion criteria:
* 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
Exclusion criteria:
* 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
Source: ClinicalTrials.gov (NCT05167331). StuddyBuddy aggregates publicly available trial information.