Clinical trial NCT04110379: Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment
Official title: Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment(Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: virtual reality
distraction
salivary cortisol
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative Venham clinical anxiety rating scale
timeFrame: Baseline; at the beginning of the visit
measure: Postoperative Venham clinical anxiety rating scale
timeFrame: post dental treatment; after 2 hours
measure: Preoperative evaluation of salivary cortisol level
timeFrame: Baseline; at the beginning of the visit
measure: Postoperative evaluation of salivary cortisol level
timeFrame: post dental treatment; after 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Yomna Alaa Eldin, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Karin M.L. Dowidar, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Laila El Habashy, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Akram Deghady, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.