Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dispositif de RV - HYPNO VR (Device)
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.
干预措施: Nitrous Oxide inhalation (Drug)
结局指标
主要结局
Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale)
时间窗: 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.
次要结局
- 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.)