Clinical trial NCT06589908: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: audiovisual sedation
anxiety
dental extraction
local anesthesia
Lead sponsor: Centre Hospitalier de Valenciennes
Sponsor class: NETWORK
First posted: 2024-09-19
Enrollment: 106
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change from baseline in visual analogue scale anxiety scores after tooth extraction
timeFrame: In the 5 minutes after the end of surgery
Secondary outcomes:
measure: Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale
timeFrame: Immediative postoperative
measure: Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale
timeFrame: In the 5 minutes after the end of surgery
measure: Rate of patients receiving at least one analgesic
timeFrame: After local anesthesia
measure: Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire
timeFrame: Immediative postoperative
measure: Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
timeFrame: 7 days (+/-3 days) after surgery
measure: Evaluation of the impact of patient agitation on the operative procedure by filling in a self-assessment questionnaire after each operative procedure.
timeFrame: Immediative postoperative
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
References: