Clinical trial NCT05720897: Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
Official title: Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment; a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment
timeFrame: End of the appointment, approximately 90+ minutes after baseline
measure: Visual Analog Score (VAS) at the End of the Appointment
timeFrame: End of the appointment, approximately 90+ minutes after baseline
measure: Systolic Blood Pressure (SBP) at the End of the Appointment
timeFrame: End of the appointment, approximately 90+ minutes after baseline
measure: Diastolic Blood Pressure (DBP) at the End of the Appointment
timeFrame: End of the appointment, approximately 90+ minutes after baseline
measure: Heart Rate (HR) at the End of the Appointment
timeFrame: End of the appointment, approximately 90+ minutes after baseline
measure: State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment
timeFrame: End of the appointment, approximately 90+ minutes after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University, School of Dentistry
state: Indiana
Study officials:
affiliation: Indiana University
name: Stuart Schrader, PhD
role: PRINCIPAL_INVESTIGATOR
References: