Clinical trial NCT06436118: Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia
Official title: Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia Compared to Those Who do Not Use the Glasses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Audiovisual sedation
anxiety
hand surgery
locoregional anesthesia
Lead sponsor: Centre Hospitalier de Valenciennes
Sponsor class: NETWORK
First posted: 2024-05-30
Enrollment: 171
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: More than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. The management of this intraoperative anxiety is essential for the comfort. The use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or 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. It is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects.

The investigators have therefore chosen to use the RELAX® glasses. There are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. The investigatos would like to study its action on the anxiety, pain and global satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients treated for hand surgery under emergency locoregional anesthesia (Wounds, fractures and infections of the hand and wrist).
* Over 15 years and 3 months of age on the day of inclusion.
* Patient with written consent or additional parental consent in the case of minor patients.
* Socially insured patient.
* Patient willing to comply with all study procedures and duration.

Exclusion Criteria:

* Medical history contraindicating RELAX glasses: claustrophobia.
* Known and current alcohol and/or illicit drug abuse that may interfere with patient safety and/or compliance.
* Any condition that would make the patient unfit for the study: current presence of cognitive impairment (MMS \<15), severe psychiatric disorders (bipolar disorder, psychotic disorders according to the DSM-V classification).
* Pregnant or breastfeeding woman.
* Patient under court protection.
* Patient participating in another study.
* Patient's refusal to use the headset.

Primary outcomes:
measure: Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
timeFrame: In the 5 minutes after the end of emergency hand 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: Immediate postoperative
measure: Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale
timeFrame: In the 5 minutes after the end of emergency hand surgery
measure: Rate of patients receiving at least one additional analgesic
timeFrame: Immediate after locoregional anaesthesia
measure: Rate of patients receiving at least one additional anxiolytic
timeFrame: Immediate after locoregional anaesthesia
measure: Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
timeFrame: 7-days after emergency hand surgery
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
References: