Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia (RELAX)

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

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 Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Behavioral: RELAX® glasses

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Valenciennes, France, 59300
    • Centre Hospitalier de Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group with RELAX® glasses	Behavioral: RELAX® glasses; Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use.
No Intervention: Group without RELAX® glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in visual analogue scale anxiety scores after emergency hand surgery	The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.	In the 5 minutes after the end of emergency hand surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale	The visual analogue satisfaction scale ranges from 0 to 10, with 0 meaning unsatisfaction and 10 indicating very high satisfaction.	Immediate postoperative
Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale	The visual analogue pain scale ranges from 0 to 10, with 0 meaning non pain and 10 meaning very high pain	In the 5 minutes after the end of emergency hand surgery
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
Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score	Only in patients receiving RELAX glasses : If the STAI-YB score is higher than 65, the patient is considered to have pre-existing anxiety.	7-days after emergency hand surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Valenciennes

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; hand surgery; locoregional anesthesia; Audiovisual sedation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2021-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No