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

Not Applicable

Completed

• Conditions: Dental Anxiety
• Interventions: Behavioral: Virtual Reality (VR); Behavioral: Conventional Behavior Management Techniques

• Registration Number: NCT04110379
• Lead Sponsor: Nourhan M.Aly

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-07-20
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality (VR)	Virtual Reality (VR)	Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))
Conventional Behavior Management	Conventional Behavior Management Techniques	Child behavior management will be done using conventional behavior management techniques

Primary Outcome Measures

Name	Time	Method
Postoperative evaluation of salivary cortisol level	post dental treatment; after 2 hours	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.
Preoperative Venham clinical anxiety rating scale	Baseline; at the beginning of the visit	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
Postoperative Venham clinical anxiety rating scale	post dental treatment; after 2 hours	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
Preoperative evaluation of salivary cortisol level	Baseline; at the beginning of the visit	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt