Effect of headset-based distraction using passive virtual reality and interactive mixed reality on dental anxiety in children: a split-mouth randomized cross-over clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess and compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on dental anxiety using an objective scale and physiological parameters for children scheduled to undergo dental treatment which requires intraoral injection.
研究概览
简要总结
METHOD:
Patients will be recruited from the outpatient setting of Department of Dentistry (Unit of Pediatric and Preventive Dentistry), University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi. The study will be conducted as a split-mouth study. A total of 100 systemically healthy subjects in the age group of 8-12 years requiring dental treatment in the mandibular arch which involves administration of intraoral injection will be included in the study. After satisfying the inclusion and exclusion criteria, subjects will be randomly assigned to one of the following two groups using computer-generated random table.
Group HBPD: Headset based passive distraction (HBPD) using virtual reality.
Group HBID: Headset based interactive distraction (HBID) using mixed reality.
Procedure with timing of measurement of primary and secondary objectives:
| PRIMARY OUTCOME MEASURES |
|Anxiety
Pain
|Vehnam clinical anxiety rating scale
Physiological parameters
Wong baker faces pain rating scale
Sound, Eye and Motor scale
Anxiety measurement:
Baseline anxiety levels (A) will be measured in all patients in the waiting area before random allocation in any of the two groups at baseline dental examination visit (V0). After dividing patients into either HBPD or HBID groups using a computer generated random table and before the start of any procedure, an operator will record preoperative anxiety levels (A1) using Venham Clinical Anxiety Rating Scale (VCARS). Anxiety will again be measured by the same operator after dental treatment completion and removal of all interventions in both the groups using the Venham Clinical Anxiety Rating Scale (A2).
| Treatment phase |
Measurement of anxiety through physiological parameters
|Pre-treatment phase
Before the start of procedure, the patient will be seated comfortably and in a relaxed, isolated environment. 5 minutes preceding the application of any intervention, heart rate (H1) and oxygen saturation (O1) will be measured as preoperative parameters.
|Treatment phase
Immediately after administration of intraoral injection, heart rate (H2) and oxygen saturation (O2) will be measured as intraoperative parameters.
|Post-treatment phase
Post-operative heart rate (H3) and oxygen saturation (O3) will be measured 5 minutes after the procedure has been completed.
The pain measurement will be done immediately after administration of intraoral injection. Two scales will be used for measurement of pain: a self-reported scale (Wong Baker FACES Pain Rating Scale) and a non-self-reported scale (Sound, Eye, Motor scale).
| SECONDARY OUTCOME MEASURES |
|Behaviour
Acceptability and feasibility of headset
Questionnaire
|Venham behaviour rating scale
Visual Analogue Scale
Researcher-based questionnaire
Behaviour assessment:
The behaviour rating scale ‘Venham Behaviour Rating Scale’ for overall behaviour will be used for assessment of behaviour at the end of the treatment procedure. It is a non-self-reported scale with scores ranging from 0-5. The operating dentist will assess the behaviour after each treatment visit.
Acceptability and feasibility of headset:
Visual Analogue Scale (VAS) will be used for assessment of acceptability and feasibility of headset worn by children, as measured by parents. This will be done after the completion of both dental treatment visits (V2).
Researcher-based questionnaire (self-designed):
A questionnaire regarding the comfort and acceptability of the Meta Quest 3S headset will be given to the child to answer. The questionnaire will be presented in English or Hindi based on the language that the child prefers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Day(s) 至 12.00 Day(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA:
- •Children aged 8-12 years of both sexes.
- •Children requiring dental treatment in the mandibular arch under local anesthesia.
- •Children belonging to American Society of Anesthesiologists (ASA) category I.
- •Children belonging to Frankl Behavior Rating of 2 (negative) or 3 (positive).
- •Children whose parents agree to take part in the study.
排除标准
- •EXCLUSION CRITERIA:
- •Children having undergone any previous dental treatment.
- •Children allergic to local anesthesia (confirmed through a patch test).
- •Children with known intellectual or developmental disabilities.
- •Children having undergone any previous pharmacological behavior management.
- •Children requiring emergency dental care.
- •Children with a known history of epilepsy.
- •Children with known visual impairment.
- •Children with any known skin infection.
- •Children with a known history of vertigo and claustrophobia.
结局指标
主要结局
To assess and compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on dental anxiety using an objective scale and physiological parameters for children scheduled to undergo dental treatment which requires intraoral injection.
时间窗: IN THE WAITING AREA, BEFORE START OF TREATMENT, DURING TREATMENT AND AFTER TREATMENT
次要结局
- To assess & compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on pain for children scheduled to undergo dental treatment.(AFTER TREATMENT COMPLETION)
- To assess and compare the effectiveness of HBPD using virtual reality with HBID using mixed reality on behaviour at the end of dental treatment.(BEFORE AND AFTER TREATMENT)
- To evaluate the acceptability and feasibility of the headset used by children, as assessed by parents at the end of treatment.(AFTER TREATMENT COMPLETION)
- To evaluate comfort of the headset used through a researcher-based questionnaire in both the groups, as answered by children at the end of treatment.(AFTER TREATMENT COMPLETION)
研究者
URVI BHATIA
UNIVERSITY COLLEGE OF MEDICAL SCINECES