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

NCT06436118 | Completed

• 1 other identifier: 2021-05
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Audiovisual sedation; anxiety; hand surgery; locoregional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

  7-days after emergency hand surgery

Study Arms (2)

Group with RELAX® glasses

EXPERIMENTAL

Behavioral: RELAX® glasses

Group without RELAX® glasses

NO INTERVENTION

Interventions

RELAX® glasses BEHAVIORAL

Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use.

Group with RELAX® glasses

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated for hand surgery under emergency locoregional anesthesia (Wounds, fractures and infections of the hand and wrist).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Valenciennes: lead

Study Sites (1)

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: May 30, 2024
• Study Start: May 2, 2022
• Primary Completion: August 30, 2022
• Study Completion: September 6, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

FR (1)