## Protocol Section
### Identification Module
**NCT ID:** NCT06425835

**Acronym:** VR

**Brief Title:** Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments

**Official Title:** Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)

#### Organization Study ID Info
**ID:** UMonastir2024
#### Organization
**Class:** OTHER
**Full Name:** University of Monastir
### Status Module
#### Completion Date
**Date:** 2026-12-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-14
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Monastir

#### Responsible Party

**Investigator Affiliation:** University of Monastir

**Investigator Full Name:** Pr. Semir Nouira

**Investigator Title:** PROFESSOR

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Study and evaluate the effectiveness of virtual reality in pain management.

**Detailed Description:** Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir.

For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.

* If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
* If initial VAS \<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic.

If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).

The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.

The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.

The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.

### Conditions Module

**Conditions:**

- Pain and Anxiety

- Dislocation

- Suture

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.

The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.

The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.

**Name:** VR device

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** occurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure.

**Measure:** occurrence of adverse events and patient satisfaction

**Time Frame:** 3 hours

#### Primary Outcomes

**Description:** frequency of success (%) (use of emergency analgesics)

**Measure:** frequency of success

**Time Frame:** 30 minutes

#### Secondary Outcomes

**Description:** reduction in pain assessed by the visual analog scale (mm)

**Measure:** reduction of pain

**Time Frame:** 30 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients aged 09 and 24 years
* suturing a wound
* changing a dressing
* lumbar puncture,
* peripheral venous line
* blood test
* intramuscular injection
* reduction of a fracture
* casting or plastering.

Exclusion Criteria:

* impaired consciousness
* epilepsy
* wound/infection covering the helmet area
* headache
* intellectual/mental retardation
* nausea, vomiting
* patient already included in the protocol
* pain requiring immediate medical attention. analgesic (VAS \>5 and described as intolerable).

**Maximum Age:** 24 Years

**Minimum Age:** 9 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.

* If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
* If initial VAS\<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** semir.nouira@rns.tn

**Name:** NOUIRA Semir, PR

**Phone:** 73106000

**Phone Ext:** 216

**Role:** CONTACT

**Contact 2:**

**Email:** gannounimen@yahoo.fr

**Name:** GANNOUN IMEN, ARC

**Phone:** 73106000

**Phone Ext:** 216

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

- 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

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M7385

- Name: Joint Dislocations

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-31
