Virtual Reality Distraction for Dental Anxiety (PILOT)

NCT05898100 | Completed

• 1 other identifier: VR-TOOTH-PILOT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Dental fear and anxiety (DFA) is a condition that affects approximately a quarter of children and adolescents. Lack of patient cooperation due to DFA can create an environment of stress, often obligating dentists to end appointments prematurely. Virtual reality use could improve DFA in children with special health care needs (SHCN) undergoing dental procedures. Aim. Assess the feasibility and acceptability of VR immersion as a tool to reduce dental fear and anxiety in pediatric special needs patients undergoing dental procedures and gain insight on parents and healthcare providers perspectives on the use of VR during dental appointments. Methods. This pilot randomized controlled trial study will follow a parallel design including two groups: A control group (clinic's standard care) and an experimental group (virtual reality). Twenty participants will be randomized to either group. Recruitment will be carried out at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary-quaternary care center that mostly serves pediatric patients with SHCN. The experimental group will receive the VR video game Dream designed specifically for this study. It aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. The VR headset offers children with the ability of viewing the game they are playing in real time while simultaneously obstructing the partial view they would normally have of the procedure. The primary outcome will be assessment of dental fear and anxiety in children using both observation-based proxy assessment with the Venham Anxiety and Behavior Rating Scale (VABRS) and a physiological biomarker such as the level of salivary alpha-amylase. Sociodemographic characteristics, measures of level of satisfaction of parents and healthcare professionals, occurrence of side effects and any deviation from normal procedure length will also be collected. Analysis will be carried out using statistical analysis software SAS (version 9.4; Cary, NC, USA). Descriptive statistics will be conducted for demographic and clinical variables and will be used to present parents and healthcare professionals' satisfaction levels, and also procedural time. Discussion. The investigators believe that the results of this pilot study will provide a better understanding of the feasibility and effect of VR on DFA in children with SHCN.

Conditions

Dental Anxiety; Dental Phobia; Dental Trauma; Dental Diseases

Outcome Measures

Primary Outcomes (5)

• The patient recruitment rates and of completion rate of planned procedures

  The feasibility and acceptability of VR distraction for children with special needs requiring dental procedures will be assessed by recording patient recruitment rates and of completion rate of planned procedures.

  Patient requirement rates and completion rate of planned procedures will be reported throughout study completion (approx 1 year)

• Parent's or legal guardian's satisfaction

  Parent's or legal guardian's satisfaction on the intervention and side effects will be assessed using the Visual analog Scale, (0-10, where 0 is very dissatisfied and 10 in very satisfied) and following the recommended question by Pediatric Initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (PedIMMPACT): "Considering anxiety relief, side effects and emotional recovery, how satisfied were you with the intervention used to manage dental fear and anxiety experienced by your child?"

  Satisfaction questionnaire is reported by parents immediately following completion of the dental procedure

• Anxiety

  Mean difference in dental fear and anxiety score as measured by proxy using the Venham Anxiety and Behavioral Rating Scale

  Anxiety scale score is recorded by the operator at the following timepoints: Before the dental procedure to establish baseline; immediately after of completion of dental intervention appointment

• Healthcare professional's satisfaction

  Healthcare professional's satisfaction on the intervention and side effects will be assessed using the Visual Analog Scale, (VAS; ranked from 0-10, where 0 is very dissatisfied and 10 in very satisfied) used to answer the 7-item tailored questionnaire.

  Satisfaction questionnaire is reported by healthcare professional immediately following completion of the dental procedure

• Change in Salivary Alpha-Amylase Concentrations before and after dental procedure

  Mean difference in salivary alpha-amylase concentration results.

  Salivary amylase swab will be performed at the following timepoints: Baseline pre-dental procedure; immediately after completion of dental intervention appointment

Secondary Outcomes (3)

• Occurrence of side effects

  Any occurence in side effects will be recorded at the following timepoints: baseline pre- dental intervention , during the dental intervention, and immediately after completion of dental intervention appointment

• Length of procedure

  The length of the procedure will be noted immediately after completion of the dental intervention appointment

• Number of rescheduled of procedures

  Any need to reschedule procedures immediately after completion of dental intervention appointment

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

Use of virtual reality (VR) during dental procedure.

Device: Virtual Reality Distraction

Standard Treatment

ACTIVE COMPARATOR

Dental Clinic's standard treatment during dental procedure.

Behavioral: Dental Clinic's Standard Treatment

Interventions

Virtual Reality Distraction DEVICE

The experimental group will receive the VR video game Dream designed specifically for this study. Pharmaceutical treatment during the procedure such as the use of injected local anesthesia will be used if the procedure requires. Children will be able to play for the entire duration of the dental procedure. Dream aims at reducing anxiety in children aged 6 to 17 years old by mean of immersive distraction. The VR headset offers children with the ability of viewing the game they are playing in real time while simultaneously obstructing the partial view they would normally have of the procedure. In the event of non-cooperation during the appointment, any re-take or re-scheduling appointments will be compiled by the resident dentist. One parent will be allowed in the room during the dental procedure and their presence will be recorded.

Virtual Reality Distraction

Dental Clinic's Standard Treatment BEHAVIORAL

The control group will only receive a care-as-usual approach. This includes a television mounted on the wall showing cartoons and the use of pharmaceutical treatment during the procedure such as the use of injected local anesthesia. In the event of non-cooperation during the appointment, any re-take or re-scheduling appointments will be compiled by the resident dentist. One parent will be permitted to be present in the room during the procedure as part of the clinic's usual protocol and their presence will be recorded. Children allocated to the control group will be offered the possibility to try the VR game after the study period if they choose so.

Standard Treatment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 to 17 years
• Received the dentist's recommendation to participate
• Required to undergo any dental procedure
• Accompanied by a parent or a legal guardian who can understand, read, and write in either French or English.

You may not qualify if:

• Suffer from epilepsy or any other conditions preventing them from using virtual reality (VR).

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St.Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

Location

Related Publications (26)

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• Wu W, Le May S, Hung N, Fortin O, Genest C, Francoeur M, Guingo E, St-Arneault K, Sylfra A, Vu AK, Carmel J, Lessard L, Cara-Slavich S, De Koven K, Paquette J, Hoffman H, Asselin ME. Effects of a Virtual Reality Game on Children's Anxiety During Dental Procedures (VR-TOOTH): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 10;12:e49956. doi: 10.2196/49956.

  PMID: 37948113 DERIVED

Related Links

• American Academy of Pediatric Dentistry. Management of dental patients with special health care needs. The Reference Manual of Pediatric Dentistry.

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: June 12, 2023
• Study Start: June 6, 2023
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)