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

NCT05720897 | Completed Results FDA Device

• 1 other identifier: IRB # 17053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (6)

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

  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.

  End of the appointment, approximately 90+ minutes after baseline

• Visual Analog Score (VAS) at the End of the Appointment

  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.

  End of the appointment, approximately 90+ minutes after baseline

• Systolic Blood Pressure (SBP) at the End of the Appointment

  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.

  End of the appointment, approximately 90+ minutes after baseline

• Diastolic Blood Pressure (DBP) at the End of the Appointment

  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.

  End of the appointment, approximately 90+ minutes after baseline

• Heart Rate (HR) at the End of the Appointment

  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.

  End of the appointment, approximately 90+ minutes after baseline

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

  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.

  End of the appointment, approximately 90+ minutes after baseline

Study Arms (2)

Auditory Alone Brief Relaxation

EXPERIMENTAL

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

Relaxation Virtual Reality

EXPERIMENTAL

Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure.

Device: Relaxation Virtual Reality

Interventions

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.

Also known as: ABR

Auditory Alone Brief Relaxation

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.

Also known as: RVR

Relaxation Virtual Reality

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• requires non-surgical root canal treatment
• is able to independently provide informed consent for root canal treatment
• proficient in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University, School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Stuart Schrader
• Organization: Indiana University

sschrade@iu.edu

3172781409

Study Officials

• Stuart Schrader, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 9, 2023
• Study Start: January 11, 2023
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (1)