NCT05720897

Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment

Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment; a Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate non-drug approaches to reducing dental anxiety prior to non-surgical root canal treatment. This will be done by comparing two relaxation methods which will be performed immediately prior to scheduled, clinical non-surgical root canal treatment. Measures of anxiety will be evaluated prior to, and after, the relaxation intervention, as well as after the non-surgical root canal treatment is completed. Participation in the study is completed in a single study visit.

Detailed description

Fifty-eight participants who needed non-surgical root canal treatment were randomly assigned into 2 groups of ABR and VRR. One group received earphones to listen to a guided brief relaxation recording, focusing on a body scan of tense points with diaphragmatic breathing. The other group received Meta 2 virtual reality headsets to listen and watch a 360 inclusive and integrative experience of ambient music, high resolution graphic illustrations and immersive scenery. Participants self-reported levels of anxiety were assessed prior to and post treatment by conducting evaluations using the State Trait Anxiety Indicator (STAI-State \& Trait) and the use of both a self-reported Visual Analog Scale (VAS) as well as by assessing objective secondary biometrics of anxiety of heart rate (HR) and Blood Pressure (BP) pre intervention, post intervention and following treatment completion.

Conditions

• Dental Anxiety

Interventions

Type	Name	Description
OTHER	Auditory Alone	Participants randomized to this arm will receive earphones to listen to an 8 minute guided brief relaxation recording, focusing on breathing and a body scan. Participants will listen to the recording prior to their dental procedure.
DEVICE	Relaxation Virtual Reality	Participants randomized to this arm will receive will receive virtual reality goggles and choose a scene of their liking to experience. Participants will choose from 11 different themed environments (such as savannah, beach, meadow, or space), and will experience the chosen virtual reality environment for 8 minutes. Participants will complete the virtual reality intervention prior to their dental procedure.

Timeline

• Start date: 2023-01-11
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2023-02-09
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study