Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments (VR)

May 21, 2024 updated by: Pr. Semir Nouira, University of Monastir

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

Study and evaluate the effectiveness of virtual reality in pain management.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of success
Time Frame: 30 minutes
frequency of success (%) (use of emergency analgesics)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of pain
Time Frame: 30 minutes
reduction in pain assessed by the visual analog scale (mm)
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of adverse events and patient satisfaction
Time Frame: 3 hours
occurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMonastir2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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