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

NCT ID: NCT06436118

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-02
• Study Completion Date: 2022-09-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group with RELAX® glasses

Group Type: EXPERIMENTAL

RELAX® glasses

Intervention Type: BEHAVIORAL

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

Group without RELAX® glasses

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RELAX® glasses

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier de Valenciennes

Valenciennes, , France

Countries

France

Other Identifiers

2021-05

Identifier Type: -

Identifier Source: org_study_id