Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment

Study Overview
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Brief Summary
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The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) to conventional behavior management techniques as a distraction method on child's dental anxiety during dental treatment

Detailed Description
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The study to be conducted will be a randomized controlled clinical trial .The sample will consist of forty children presented to the Department of Pediatric Dentistry and Dental Public Health, 20 preschoolers of age ranging from 4-5 years old and 20 schoolers of age ranging from 6-8 years old. The eligible participants will be randomly divided into a study group where virtual reality glasses distraction will be used for child behavior management and a control group where conventional behavior management techniques (tell-show-do, distraction, and positive reinforcement) will be used.

Official Title
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Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment(Randomized Controlled Clinical Trial)

Conditions
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Dental Anxiety

Intervention / Treatment
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* Behavioral: Virtual Reality (VR)
* Behavioral: Conventional Behavior Management Techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children (ASA category I). Frankl behavior rating score 2 or 3. Requiring pulpotomy in one of their primary molars. Exclusion Criteria: Children taking medications that interfere with measures of salivary cortisol. Presence of any systemic or mental disease.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The eligible participants will be randomly and equally divided into group I (study) and group II (control). Each group will be further subdivided according to age into subgroup A (preschool aged children) and subgroup B (school aged children).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality (VR)<br>Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd)) | Behavioral: Virtual Reality (VR)<br>* All the dental procedures that will be done will be explained to the child using tell-show-do technique. VR glasses will be introduced to the child using tell-show-do technique and he will be given a choice of cartoon episodes to select from according to his own interest and age appropriate to view during the dental treatment. The child will be given five minutes to get familiar with the VR glasses before starting the dental treatment.<br>|
| Active Comparator: Conventional Behavior Management<br>Child behavior management will be done using conventional behavior management techniques | Behavioral: Conventional Behavior Management Techniques<br>* Conventional behavior management techniques will be done to relieve the child's dental anxiety during the dental treatment such as : tell-show-do technique, distraction, and positive reinforcement, according to the child's behavior.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Venham clinical anxiety rating scale | This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact | Baseline; at the beginning of the visit | 
| Postoperative Venham clinical anxiety rating scale | This scale consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact | post dental treatment; after 2 hours | 
| Preoperative evaluation of salivary cortisol level | Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit. | Baseline; at the beginning of the visit | 
| Postoperative evaluation of salivary cortisol level | Each child will be asked to pool saliva in his/her mouth for 5 minutes and then passively drool it in the receiving vessel. The whole unstimulated salivary samples obtained will be centrifuged and 2 ml of each sample will be stored at -20º until being processed. The salivary samples will be analyzed for salivary cortisol using solid phase enzyme linked immunosorbent assay using DRG salivary cortisol ELISA kit. | post dental treatment; after 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, distraction, salivary cortisol