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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 171
- Locations
- 2
- Primary Endpoint
- Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
Time Frame: In the 5 minutes after the end of emergency hand surgery
The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.
Secondary Outcomes
- Rate of patients receiving at least one additional analgesic(Immediate after locoregional anaesthesia)
- Rate of patients receiving at least one additional anxiolytic(Immediate after locoregional anaesthesia)
- Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale(Immediate postoperative)
- Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale(In the 5 minutes after the end of emergency hand surgery)
- Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score(7-days after emergency hand surgery)