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Evaluation of the Use of RELAX Glasses on Anxiety of Patients Undergoing Dental Extraction > 2 Teeth, Under Local Anesthesia, Compared With Those Not Using Glasses (BRIGAND)

C

Centre Hospitalier de Valenciennes

Status

Completed

Conditions

Surgery

Treatments

Behavioral: RELAX glasses

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06589908
2023-02-02

Details and patient eligibility

About

The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure.

In 2020, Yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient.

The use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. Audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects.

The investigators have therefore chosen to use RELAX® eyewear. They wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.

Enrollment

106 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient undergoing dental extraction > 2 teeth under local anesthesia;
  • Over 14 years of age on the day of inclusion;
  • Patient with written consent or additional parental consent for minors;
  • Socially insured patient;
  • Patient willing to comply with all study procedures and duration.

Exclusion criteria

  • Medical history contraindicating RELAX glasses
  • Known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance;
  • Any condition that would render the patient unfit for the study: current presence of cognitive disorders (MMS < 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to DSM-V classification);
  • Major anxiety requiring preoperative anxiolytics;
  • Patient under court protection;
  • Patient participating in another study;
  • Patient's refusal to use glasses;
  • Visually impaired or blind patient.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

106 participants in 2 patient groups

Group with RELAX glasses
Experimental group
Description:
Behavioral : RELAX glasses Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use
Treatment:
Behavioral: RELAX glasses
Group without RELAX glasses
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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