Dental Anxiety Clinical Trial
Official title:
Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial
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.
The working hypothesis of this study is that hypnosis through virtual reality can reduce children's anxiety as well as their pain level during dental care with an efficiency and tolerance at least similar to nitrous oxide inhalation. Specifically, the statistical analyses will be based on an assumption of non-inferiority of VR compared to the pharmacological technique of nitrous oxide sedation. 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06385314 -
A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
|
||
| Completed |
NCT04308005 -
Drawing as a Measurement of Dental Anxiety
|
||
| Completed |
NCT01908127 -
Efficacy of Film Modelling in Paediatric Dentistry
|
N/A | |
| Completed |
NCT00695630 -
Flumazenil Reversal of Oral Triazolam
|
Phase 1/Phase 2 | |
| Completed |
NCT05759286 -
A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient
|
N/A | |
| Completed |
NCT04234737 -
Efficacy of Hypnotherapy in Children With Dental Anxiety
|
N/A | |
| Completed |
NCT03838081 -
Evaluation on the Anxiety of Third Molar Extraction
|
N/A | |
| Enrolling by invitation |
NCT06057090 -
Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
|
N/A | |
| Not yet recruiting |
NCT04924452 -
Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Patients
|
N/A | |
| Completed |
NCT03596255 -
Clinical Estimation of Dental Anxiety
|
||
| Completed |
NCT03722771 -
Influence of Lavender Oil on Vital Signs in Oral Surgery Patients
|
N/A | |
| Completed |
NCT05038540 -
The Effect of Virtual Reality Glasses on Dental Anxiety Control
|
N/A | |
| Completed |
NCT03324347 -
Dog-Assisted Therapy in Dentistry
|
N/A | |
| Not yet recruiting |
NCT06139640 -
The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children
|
N/A | |
| Completed |
NCT02588079 -
Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
|
N/A | |
| Completed |
NCT02591797 -
Effectiveness of Hand/Eyes/Mouth Behavior Management Technique During Local Anesthesia in Preschool Children
|
N/A | |
| Not yet recruiting |
NCT00355693 -
Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol in Anxious Patients
|
Phase 4 | |
| Recruiting |
NCT06243705 -
Effectiveness of Robot-pets in Reducing Dental Anxiety in Children
|
N/A | |
| Recruiting |
NCT06058533 -
Pre-Visit Positive Imagery in Reducing Dental Anxiety
|
N/A | |
| Completed |
NCT03993080 -
Virtual Reality Relaxation to Decrease Dental Anxiety
|
N/A |