Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie
NCT ID: NCT05167331
Last Updated: 2022-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-02-28
2023-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Virtual Reality
* (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.
Dispositif de RV - HYPNO VR
use of Virtual Reality on children's anxiety during a dental treatment
Nitrous oxide sedation
* (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.
Nitrous Oxide inhalation
use of Nitrous Oxide inhalation on children's anxiety during a dental treatment
Interventions
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Nitrous Oxide inhalation
use of Nitrous Oxide inhalation on children's anxiety during a dental treatment
Dispositif de RV - HYPNO VR
use of Virtual Reality on children's anxiety during a dental treatment
Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Years
10 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Les Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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8113
Identifier Type: -
Identifier Source: org_study_id
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