METHODS: This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis.
DISCUSSION: This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia.
TRIAL REGISTRATION NUMBER: ISRCTN25824611 , Date of registration: 26 October 2015.
METHOD: A single-blind RCT was conducted among 30 randomized patients with dental phobia to either VRET or informational pamphlet (IP) condition. Primary outcome anxiety measures (VAS-A, MDAS and DFS) were evaluated at baseline, pre- and post-intervention, 1-week, 3-months and 6-months follow-up. Secondary outcome measures assessed were pre-post behavioral avoidance, temporal variations of heart rate and VR-experience during and post-VRET, and dental treatment acceptance in both conditions at 6-month follow-up.
RESULTS: Intention to treat analysis, using a repeated measures MANOVA, revealed a multivariate interaction effect between time and condition (p = 0.015) for all primary outcome measures (all ps