Status:
COMPLETED
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
Lead Sponsor:
Centre Hospitalier de Valenciennes
Conditions:
Surgery
Eligibility:
All Genders
14+ years
Phase:
NA
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 26 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06589908
Start Date
August 31 2023
End Date
July 26 2024
Last Update
July 2 2025
Active Locations (1)
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1
Centre Hospitalier de Valenciennes
Valenciennes, France, France, 59300