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

NCT ID: NCT06589908

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-07-26

Brief Summary

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group with RELAX glasses

Behavioral : RELAX glasses Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use

Group Type: EXPERIMENTAL

RELAX glasses

Intervention Type: BEHAVIORAL

Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use

Group without RELAX glasses

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RELAX glasses

Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier de Valenciennes

Valenciennes, France, France

Countries

France

Other Identifiers

2023-02-02

Identifier Type: -

Identifier Source: org_study_id