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

NCT06589908 | Completed

• 1 other identifier: 2023-02-02
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

audiovisual sedation; anxiety; dental extraction; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in visual analogue scale anxiety scores after tooth extraction

  The visual analogue anxiety scale from 0 to 10, with meaning no anxiety and 10 very high anxiety

  In the 5 minutes after the end of surgery

Secondary Outcomes (6)

• Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale

  Immediative postoperative

• Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale

  In the 5 minutes after the end of surgery

• Rate of patients receiving at least one analgesic

  After local anesthesia

• Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire

  Immediative postoperative

• Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score

  7 days (+/-3 days) after surgery

Study Arms (2)

Group with RELAX glasses

EXPERIMENTAL

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

Behavioral: RELAX glasses

Group without RELAX glasses

NO INTERVENTION

Interventions

RELAX glasses BEHAVIORAL

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

Group with RELAX glasses

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing dental extraction \> 2 teeth under local anesthesia;
• Patient with written consent or additional parental consent for minors;
• Socially insured patient;
• Patient willing to comply with all study procedures and duration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, France, 59300, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 31, 2023
• Primary Completion: July 18, 2024
• Study Completion: July 26, 2024
• Last Updated: July 2, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)