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

Not Applicable

Completed

• Conditions: Dental Anxiety
• Interventions: Other: Auditory Alone; Device: Relaxation Virtual Reality

• Registration Number: NCT05720897
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2023-01-09
• Study Start: 2023-01-11
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Primary Completion: 2023-04-03
• Study Completion: 2023-04-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auditory Alone Brief Relaxation	Auditory Alone	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.
Relaxation Virtual Reality	Relaxation Virtual Reality	Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure.

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	STAI-S is a 20 item sub-scale questionnaire which measures subjective self-reported feelings of state anxiety. Responses for each item include four possible responses that range from "very much" to "not at all" and which correlate to a numerical value. Scores range from 20 to 80. A score of 45-80 indicates "high anxiety": 38-44 indicate "moderate anxiety": 20-37 indicate low or no anxiety.
Visual Analog Score (VAS) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	The VAS will be a single question in which the participant is asked to assign and report a numerical value to the amount of anxiety one is feeling in the moment. It consists of a 10 point scale, with one symbolizing no anxiety and 10 symbolizing unbearable anxiety.
Systolic Blood Pressure (SBP) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	BP will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.
Diastolic Blood Pressure (DBP) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	BP will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.
Heart Rate (HR) at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	HR will be measured three times during the single study visit: at enrollment (prior to the assigned relaxation intervention), at the end of the assigned relaxation intervention, and at the end of the appointment.
State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment	End of the appointment, approximately 90+ minutes after baseline	STAI-T is a 20 item sub-scale questionnaire which measures subjective self-reported feelings of trait anxiety. Responses for each item include four possible responses that range from "not at all" to "very much" and which correlate to a numerical value. Scores range from 20 to 80. A score of 45-80 indicates "high anxiety": 38-44 indicate "moderate anxiety": 20-37 indicate low or no anxiety.

Trial Locations

Locations (1)

Indiana University, School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States