NCT03902158

Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children

Status unknown NA Last updated 3 April 2019

What this trial tests

NA trial testing Glasses in Pain in 44 participants. Status unknown.

Timeline

15 April 2019

Primary endpoint
31 December 2019

1 August 2020

Quick facts

Lead sponsor	Federal University of Pelotas
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	44
Start date	15 April 2019
Primary completion	31 December 2019
Estimated completion	1 August 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Glasses
• Distraction techniques

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Federal University of Pelotas

Who can join

Adults 5 to 9, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. This study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized with 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).

The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman's terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98') will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for increasing acceptance of local anaesthetic in children and adolescents having dental treatment.
   Monteiro J, Tanday A, Ashley PF, Parekh S, et al · · 2020 · cited 24× · PMID 32104910 · DOI 10.1002/14651858.cd011024.pub2
2. Efficacy of audiovisual distraction using eyeglasses during dental care: a randomized clinical trial.
   CustÓdio NB, Cademartori MG, Azevedo MS, Mendes MA, et al · · 2021 · cited 8× · PMID 33605356 · DOI 10.1590/1807-3107bor-2021.vol35.0026