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

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Indiana University

Status

Completed

Conditions

Dental Anxiety

Treatments

Other: Auditory Alone
Device: Relaxation Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT05720897
IRB # 17053

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Auditory Alone Brief Relaxation
Experimental group
Description:
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.
Treatment:
Other: Auditory Alone
Relaxation Virtual Reality
Experimental group
Description:
Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure.
Treatment:
Device: Relaxation Virtual Reality

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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