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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05167331

Collaborator

(none)

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety	Drug: Nitrous Oxide inhalation Device: Dispositif de RV - HYPNO VR	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: Dispositif de RV - HYPNO VR use of Virtual Reality on children's anxiety during a dental treatment
Active Comparator: 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.	Drug: Nitrous Oxide inhalation use of Nitrous Oxide inhalation on children's anxiety during a dental treatment

Arm

Intervention/Treatment

Active Comparator: 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.

Device: Dispositif de RV - HYPNO VR

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

Active Comparator: 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.

Drug: Nitrous Oxide inhalation

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

Outcome Measures

Primary Outcome Measures

Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale) [5 weeks]
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.

Secondary Outcome Measures

Assessment of analgesia with VR [5 weeks]
Assessment of analgesia using self-assessed pain levels on standardized age-appropriate scales (VAS: Visual Analogue Scale)
Assessment of children's tolerance levels to VR and pharmacological technique. [5 weeks]
Assessment of tolerance and response to VR-MEOPA using the number and proportion of patients intolerant to VR and to pharmacological techniques. Evaluate the proportion of VR or MEOPA sessions interrupted (lack of therapeutic continuity). Any patient who has interrupted VR more than once or who refused VR during the procedure is considered intolerant of VR.
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.]
To assess the child's temperament dimensions, parents answer to an Emotionality, Activity and Sociability questionnaire with the help of an investigator before the treatment session. The AES questionnaire had already been validated in France in children aged from 6 to 12 years-old in 2002. The AES questionnaire is a questionnaire containing 25 items based on a model of three main dimensions: Emotionality, Activity and Sociability. Each item has a Likert-type scale ranging from 1 (extremely false, not at all corresponding to my child) to 5 (extremely fair, corresponding to my child).

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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