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

May 9, 2023 updated by: Stuart Schrader, Indiana University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Stuart Schrader, PhD
  • Phone Number: 3172781355
  • Email: sschrade@iu.edu

Study Contact Backup

  • Name: Caley Mintz, DDS
  • Phone Number: 2197768781
  • Email: cfmintz@iu.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change from baseline in State-Trait Anxiety Indicator (STAI) Score at the end of the study visit
Time Frame: From enrollment to the end of the dental visit, approximately 90 minutes
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
Time Frame: From enrollment to the end of the relaxation intervention, approximately 10 minutes
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
Time Frame: From enrollment to the end of the dental visit, approximately 90 minutes
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
Time Frame: From enrollment to the end of the relaxation intervention, approximately 10 minutes
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
Time Frame: From enrollment to the end of the dental visit, approximately 90 minutes
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
Time Frame: From enrollment to the end of the relaxation intervention, approximately 10 minutes
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
Time Frame: From enrollment to the end of the dental visit, approximately 90 minutes
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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