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

NCT04110379 | Completed

• 1 other identifier: VR for anxiety
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Anxiety

Keywords

virtual reality; distraction; salivary cortisol

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Virtual Reality (VR)

EXPERIMENTAL

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)

Conventional Behavior Management

ACTIVE COMPARATOR

Child behavior management will be done using conventional behavior management techniques

Behavioral: Conventional Behavior Management Techniques

Interventions

Virtual Reality (VR) BEHAVIORAL

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.

Virtual Reality (VR)

Conventional Behavior Management Techniques BEHAVIORAL

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.

Conventional Behavior Management

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children (ASA category I).
• Frankl behavior rating score 2 or 3.
• Requiring pulpotomy in one of their primary molars.

You may not qualify if:

• Children taking medications that interfere with measures of salivary cortisol.
• Presence of any systemic or mental disease.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (5)

• Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.

  PMID: 27409593 BACKGROUND

• Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.

  PMID: 27022303 BACKGROUND

• Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.

  PMID: 23277857 BACKGROUND

• Fakhruddin KS, Hisham EB, Gorduysus MO. Effectiveness of audiovisual distraction eyewear and computerized delivery of anesthesia during pulp therapy of primary molars in phobic child patients. Eur J Dent. 2015 Oct-Dec;9(4):470-475. doi: 10.4103/1305-7456.172637.

  PMID: 26929683 BACKGROUND

• Gadicherla S, Shenoy RP, Patel B, Ray M, Naik B, Pentapati KC. Estimation of salivary cortisol among subjects undergoing dental extraction. J Clin Exp Dent. 2018 Feb 1;10(2):e116-e119. doi: 10.4317/jced.54369. eCollection 2018 Feb.

  PMID: 29670727 BACKGROUND

Study Officials

• Yomna Alaa Eldin, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Karin M.L. Dowidar, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Laila El Habashy, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Akram Deghady, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health

Model Details: 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).

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 1, 2019
• Study Start: July 20, 2019
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

EG (1)