Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment(Randomized Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Postoperative evaluation of salivary cortisol level
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Virtual Reality (VR)
Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))
Intervention: Virtual Reality (VR) (Behavioral)
Conventional Behavior Management
Child behavior management will be done using conventional behavior management techniques
Intervention: Conventional Behavior Management Techniques (Behavioral)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nourhan M.Aly
Instructor of Dental Public Health
University of Alexandria