## Protocol Section
### Identification Module
**NCT ID:** NCT06436118

**Acronym:** RELAX

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2021-05
#### Organization
**Class:** NETWORK
**Full Name:** Centre Hospitalier de Valenciennes
### Status Module
#### Completion Date
**Date:** 2022-09-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-08-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-05-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-29
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Centre Hospitalier de Valenciennes

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Surgery

**Keywords:**

- Audiovisual sedation

- anxiety

- hand surgery

- locoregional anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 171

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: RELAX® glasses

**Label:** Group with RELAX® glasses

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Group without RELAX® glasses

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group with RELAX® glasses

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

**Name:** RELAX® glasses

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.

**Measure:** 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

#### Secondary Outcomes

**Description:** The visual analogue satisfaction scale ranges from 0 to 10, with 0 meaning unsatisfaction and 10 indicating very high satisfaction.

**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

**Time Frame:** Immediate postoperative

**Description:** The visual analogue pain scale ranges from 0 to 10, with 0 meaning non pain and 10 meaning very high pain

**Measure:** Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale

**Time Frame:** In the 5 minutes after the end of emergency hand surgery

**Measure:** Rate of patients receiving at least one additional analgesic

**Time Frame:** Immediate after locoregional anaesthesia

**Measure:** Rate of patients receiving at least one additional anxiolytic

**Time Frame:** Immediate after locoregional anaesthesia

**Description:** Only in patients receiving RELAX glasses : If the STAI-YB score is higher than 65, the patient is considered to have pre-existing anxiety.

**Measure:** Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score

**Time Frame:** 7-days after emergency hand surgery

### Eligibility Module

**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 Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Valenciennes

**Country:** France

**Facility:** Centre Hospitalier de Valenciennes

**Zip:** 59300

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
