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Completed

NCT Number: NCT05720897

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

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.

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Key information

Conditions

Dental Anxiety

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, School of Dentistry

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory Alone

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.

Other names: ABR

Relaxation Virtual Reality

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.

Other names: RVR

Primary outcomes

  1. State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment

    Time frame: 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.

  2. Visual Analog Score (VAS) at the End of the Appointment

    Time frame: 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.

  3. Systolic Blood Pressure (SBP) at the End of the Appointment

    Time frame: 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.

  4. Diastolic Blood Pressure (DBP) at the End of the Appointment

    Time frame: 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.

  5. Heart Rate (HR) at the End of the Appointment

    Time frame: 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.

  6. State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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