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Clinical Trials/NCT04110379
NCT04110379
Completed
Not Applicable

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

Nourhan M.Aly1 site in 1 country40 target enrollmentJuly 20, 2019
ConditionsDental Anxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Anxiety
Sponsor
Nourhan M.Aly
Enrollment
40
Locations
1
Primary Endpoint
Postoperative evaluation of salivary cortisol level
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2019
End Date
October 7, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nourhan M.Aly
Responsible Party
Sponsor Investigator
Principal Investigator

Nourhan M.Aly

Instructor of Dental Public Health

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • Healthy children (ASA category I).
  • Frankl behavior rating score 2 or
  • 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.

Outcomes

Primary Outcomes

Postoperative evaluation of salivary cortisol level

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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