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

Not Applicable

Completed

• Conditions: Tooth Avulsion; Anxiety
• Interventions: Other: virtual reality

• Registration Number: NCT05963750
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Study Start: 2021-11-02
• Primary Completion: 2022-04-30
• Study Completion: 2022-07-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
virtual reality during the surgery	virtual reality	Group with the use of virtual reality during the surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
factors influencing changes in the STAI-YA anxiety score	1 day of surgery	Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.
Comparability of the results with another metric for assessing anxiety	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.
The wish to renew the virtual reality experience	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

Trial Locations

Locations (1)

CHU Caen; 🇫🇷 Caen, Normandie, France