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

NCT05963750 | Completed

• 1 other identifier: 21-0188
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Avulsion; Anxiety

Keywords

virtual reality; oral surgery; anxiety

Outcome Measures

Primary Outcomes (2)

• effectiveness of virtual reality on anxiety (STAI-YA)

  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)

  The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.

  Baseline and during the procedure.

Secondary Outcomes (3)

• Comparability of the results with another metric for assessing anxiety

  1 day of surgery

• factors influencing changes in the STAI-YA anxiety score

  1 day of surgery

• The wish to renew the virtual reality experience

  1 day of surgery

Study Arms (2)

virtual reality during the surgery

EXPERIMENTAL

Group with the use of virtual reality during the surgery

Other: virtual reality

control

NO INTERVENTION

Group without the use of virtual reality during the surgery

Interventions

virtual reality OTHER

virtual reality

virtual reality during the surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults (\> 18 years old) coming for at least two dental extractions under local anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen

Caen, Normandy, 14000, France

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Tooth Avulsion; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Mental Disorders

Study Officials

• Alexis Veyssiere, M.D

  CHU CAEN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: November 2, 2021
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: February 18, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)