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

NCT ID: NCT04110379

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2020-10-07

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.

Conditions

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Dental Anxiety

Keywords

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virtual reality distraction salivary cortisol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Virtual Reality (VR)

Child behavior management will be done using virtual reality glasses distraction (Remax Fantasy Land virtual reality glasses (Schenzen Remax Co.,Ltd))

Group Type EXPERIMENTAL

Virtual Reality (VR)

Intervention Type 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.

Conventional Behavior Management

Child behavior management will be done using conventional behavior management techniques

Group Type ACTIVE_COMPARATOR

Conventional Behavior Management Techniques

Intervention Type 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.

Interventions

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Virtual Reality (VR)

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.

Intervention Type BEHAVIORAL

Conventional Behavior Management Techniques

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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Instructor of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yomna Alaa Eldin, BDS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Karin M.L. Dowidar, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Laila El Habashy, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Akram Deghady, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 27409593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27022303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23277857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26929683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29670727 (View on PubMed)

Other Identifiers

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VR for anxiety

Identifier Type: -

Identifier Source: org_study_id