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Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia (REVIDEN)

Primary Purpose

Tooth Avulsion, Anxiety

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tooth Avulsion focused on measuring virtual reality, oral surgery, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Adults (> 18 years old) coming for at least two dental extractions under local anesthesia Exclusion Criteria: patients suffering of motion sickness, claustrophobia, uncontrolled epilepsy, visual impairment, hearing disability, non-French speakers, pregnant women, protected adults people followed by a psychiatrist whether for depression, bipolarity, schizophrenia The day of the intervention, patients who had consumed anxiolytics

Sites / Locations

  • CHU Caen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

virtual reality during the surgery

control

Arm Description

Group with the use of virtual reality during the surgery

Group without the use of virtual reality during the surgery

Outcomes

Primary Outcome Measures

effectiveness of virtual reality on anxiety (STAI-YA)
The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.
effectiveness of virtual reality on anxiety (Visual Analogue Scale)
The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.

Secondary Outcome Measures

Comparability of the results with another metric for assessing anxiety
The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.
factors influencing changes in the STAI-YA anxiety score
Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.
The wish to renew the virtual reality experience
the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality

Full Information

First Posted
July 18, 2023
Last Updated
July 26, 2023
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05963750
Brief Title
Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
Acronym
REVIDEN
Official Title
Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. There is a group with virtual reality and a control group without virtual reality. Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA score before vs during the surgery. Secondary criteria are the relevance of the chosen metric by comparing it to the VAS, defining the factors influencing the evolution of the anxiety score, studying the side effects of VR and the wish to repeat the experience.
Detailed Description
The virtual reality experience consisted of putting on a headset with music and a 3D helmet on the eyes that broadcast a landscape in motion (a walk). The inclusion took place in the University Hospital of Caen between november 2021 and may 2022. 119 patients were randomized into two groups, one with VR and another one without VR. At the end, 105 patients were analyzed. The main objective was to find a reduction in the STAI-YA score of more than 8 points between before and during the intervention. This analysis was performed in both groups. During the initial consultation, questions were asked about the medical file and informed consent was sought. Patients were then randomised to one of two groups. During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress experienced during the surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Avulsion, Anxiety
Keywords
virtual reality, oral surgery, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A list with numbers from 1 to 120 was produced prior to the study on Excel. Each number was assigned a random group (with and without VR). During the first consultation, the patient was assigned a number (the practitioner followed the list on Excel) and therefore a group. Both practitioner and patient knew the patient's group for the next appointment. When the patient filled out the questionnaires, he was referring to his assigned number and not his name. Then, the practitioner filled in the Excel file with the data collected (characteristics of the patients, STAI-YA score, VAS), which were associated with the patient's number, and which were therefore anonymous.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality during the surgery
Arm Type
Experimental
Arm Description
Group with the use of virtual reality during the surgery
Arm Title
control
Arm Type
No Intervention
Arm Description
Group without the use of virtual reality during the surgery
Intervention Type
Other
Intervention Name(s)
virtual reality
Intervention Description
virtual reality
Primary Outcome Measure Information:
Title
effectiveness of virtual reality on anxiety (STAI-YA)
Description
The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.
Time Frame
Baseline and during the procedure.
Title
effectiveness of virtual reality on anxiety (Visual Analogue Scale)
Description
The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.
Time Frame
Baseline and during the procedure.
Secondary Outcome Measure Information:
Title
Comparability of the results with another metric for assessing anxiety
Description
The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.
Time Frame
1 day of surgery
Title
factors influencing changes in the STAI-YA anxiety score
Description
Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.
Time Frame
1 day of surgery
Title
The wish to renew the virtual reality experience
Description
the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality
Time Frame
1 day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Adults (> 18 years old) coming for at least two dental extractions under local anesthesia Exclusion Criteria: patients suffering of motion sickness, claustrophobia, uncontrolled epilepsy, visual impairment, hearing disability, non-French speakers, pregnant women, protected adults people followed by a psychiatrist whether for depression, bipolarity, schizophrenia The day of the intervention, patients who had consumed anxiolytics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Veyssiere, M.D
Organizational Affiliation
CHU Caen
Official's Role
Study Director
Facility Information:
Facility Name
CHU Caen
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
this is not planned

Learn more about this trial

Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia

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