Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720897
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2023-01-09
Brief Title:
Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None