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

NCT ID: NCT05720897

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2023-04-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Auditory Alone Brief Relaxation

Participants randomized to this arm will receive earphones to listen to a guided brief relaxation recording, focusing on breathing and a body scan, prior to their dental procedure.

Group Type: EXPERIMENTAL

Auditory Alone

Intervention Type: OTHER

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.

Relaxation Virtual Reality

Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure.

Group Type: EXPERIMENTAL

Relaxation Virtual Reality

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

ABR; RVR

Eligibility Criteria

Inclusion Criteria

• requires non-surgical root canal treatment
• is able to independently provide informed consent for root canal treatment
• proficient in English

Exclusion Criteria

• history of vertigo or severe motion sickness
• history of severe psychiatric disease
• history of seizures, concussions, or severe neurological conditions
• visual or hearing impairments
• cardiac pacemaker or defibrillator
• will require nitrous oxide sedation, nor pharmacologic anxiolytics or sedatives for dental treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Stuart Schrader

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stuart Schrader, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University, School of Dentistry

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB # 17053

Identifier Type: -

Identifier Source: org_study_id