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

February 16, 2026 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandy
      • Caen, Normandy, France, 14000
        • CHU caen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality during the surgery
Group with the use of virtual reality during the surgery
Other: virtual reality
virtual reality
No Intervention: control
Group without the use of virtual reality during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of virtual reality on anxiety (STAI-YA)
Time Frame: Baseline and during the procedure.
The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.
Baseline and during the procedure.
effectiveness of virtual reality on anxiety (Visual Analogue Scale)
Time Frame: Baseline and during the procedure.
The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.
Baseline and during the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparability of the results with another metric for assessing anxiety
Time Frame: 1 day of surgery
The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.
1 day of surgery
factors influencing changes in the STAI-YA anxiety score
Time Frame: 1 day of surgery
Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.
1 day of surgery
The wish to renew the virtual reality experience
Time Frame: 1 day of surgery
the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality
1 day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Study Director: Alexis Veyssiere, M.D, CHU caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Reducing the anxiety of adults during dental avulsions with virtual reality: a randomized controlled trial Anaïs Protin, Hervé Bénateau, Jean-François Sergent, Dorian Henry, Guillaume Gautier and Alexis Veyssière J Oral Med Oral Surg, 30 2 (2024) 12 DOI: https://doi.org/10.1051/mbcb/2024014

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-0188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

this is not planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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