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

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Auditory Alone; Device: Relaxation Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: ABR
Experimental: Relaxation Virtual Reality; Participants will receive virtual reality goggles and choose a scene of their liking to experience, 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.; Other Names: RVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from baseline in State-Trait Anxiety Indicator (STAI) Score at the end of the study visit	STAI is a 40 item questionnaire which measures subjective self-reported feelings of dental 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. A score of 45-80 indicate "high anxiety": 38-44 indicate "moderate anxiety": 20-37 indicate low or no anxiety. During the single study visit, participants will complete the STAI twice: at enrollment (prior to undergoing the randomly assigned relaxation intervention) and again at the end of the visit.	From enrollment to the end of the dental visit, approximately 90 minutes
Mean Change from baseline in anxiety as rated on a Visual Analog Score (VAS) at the end of the relaxation intervention	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. During the single study visit, participants will complete the VAS three times: at enrollment (prior to the assigned relaxation intervention), at the end of the relaxation intervention, and at the end of the study visit.	From enrollment to the end of the relaxation intervention, approximately 10 minutes
Mean Change from baseline in anxiety as rated on a Visual Analog Score (VAS) at the end of the study visit	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. During the single study visit, participants will complete the VAS three times: at enrollment (prior to the assigned relaxation intervention), at the end of the relaxation intervention, and at the end of the study visit.	From enrollment to the end of the dental visit, approximately 90 minutes
Mean Change from baseline in blood pressure (BP) at the end of the relaxation intervention	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 visit.	From enrollment to the end of the relaxation intervention, approximately 10 minutes
Mean Change from baseline in blood pressure (BP) at the end of the study visit	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 visit.	From enrollment to the end of the dental visit, approximately 90 minutes
Mean Change from baseline in heart rate (HR) to the end of the relaxation intervention	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 study visit.	From enrollment to the end of the relaxation intervention, approximately 10 minutes
Mean Change from baseline in heart rate (HR) at the end of the study visit	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 study visit.	From enrollment to the end of the dental visit, approximately 90 minutes

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): April 3, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRB # 17053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes