Back to resultsComparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory Alone
Relaxation Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety
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
Sites / Locations
- Indiana University, School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Auditory Alone Brief Relaxation
Relaxation Virtual Reality
Arm Description
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.
Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure.
Outcomes
Primary Outcome Measures
Mean Change from baseline in State-Trait Anxiety Indicator (STAI) Score at the end of the study visit
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.
Mean Change from baseline in anxiety as rated on a Visual Analog Score (VAS) at the end of the relaxation intervention
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.
Mean Change from baseline in anxiety as rated on a Visual Analog Score (VAS) at the end of the study visit
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.
Mean Change from baseline in blood pressure (BP) at the end of the relaxation intervention
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.
Mean Change from baseline in blood pressure (BP) at the end of the study visit
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.
Mean Change from baseline in heart rate (HR) to the end of the relaxation intervention
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.
Mean Change from baseline in heart rate (HR) at the end of the study visit
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05720897
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
April 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auditory Alone Brief Relaxation
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxation Virtual Reality
Arm Type
Experimental
Arm Description
Participants will receive virtual reality goggles and choose a scene of their liking to experience, prior to their dental procedure.
Intervention Type
Other
Intervention Name(s)
Auditory Alone
Other Intervention Name(s)
ABR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Relaxation Virtual Reality
Other Intervention Name(s)
RVR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change from baseline in State-Trait Anxiety Indicator (STAI) Score at the end of the study visit
Description
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.
Time Frame
From enrollment to the end of the dental visit, approximately 90 minutes
Title
Mean Change from baseline in anxiety as rated on a Visual Analog Score (VAS) at the end of the relaxation intervention
Description
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.
Time Frame
From enrollment to the end of the relaxation intervention, approximately 10 minutes
Title
Mean Change from baseline in anxiety as rated on a Visual Analog Score (VAS) at the end of the study visit
Description
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.
Time Frame
From enrollment to the end of the dental visit, approximately 90 minutes
Title
Mean Change from baseline in blood pressure (BP) at the end of the relaxation intervention
Description
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.
Time Frame
From enrollment to the end of the relaxation intervention, approximately 10 minutes
Title
Mean Change from baseline in blood pressure (BP) at the end of the study visit
Description
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.
Time Frame
From enrollment to the end of the dental visit, approximately 90 minutes
Title
Mean Change from baseline in heart rate (HR) to the end of the relaxation intervention
Description
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.
Time Frame
From enrollment to the end of the relaxation intervention, approximately 10 minutes
Title
Mean Change from baseline in heart rate (HR) at the end of the study visit
Description
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.
Time Frame
From enrollment to the end of the dental visit, approximately 90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Indiana University, School of Dentistry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
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Comparing Brief Relaxation Period to Virtual Reality Period in Reducing Dental Anxiety Prior to Root Canal Treatment
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