N/A
N=60
Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
Dental Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT05720897 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment — 27.39; 29.37 units on a scale — p=.399
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Auditory Alone (Other); Relaxation Virtual Reality (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY State-Trait Anxiety Inventory State Sub-scale (STAI-S) Score at the End of the Appointment |
27.39; 29.37 | .399 |
| PRIMARY Visual Analog Score (VAS) at the End of the Appointment |
0.96; 1.17 | — |
| PRIMARY Systolic Blood Pressure (SBP) at the End of the Appointment |
142.64; 137.47 | — |
| PRIMARY Diastolic Blood Pressure (DBP) at the End of the Appointment |
90.00; 85.97 | — |
| PRIMARY Heart Rate (HR) at the End of the Appointment |
72.89; 72.17 | — |
| PRIMARY State-Trait Anxiety Inventory Trait Sub-scale (STAI-T) Score at the End of the Appointment |
30.18; 29.90 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05720897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.