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NCT Number: NCT06425835

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

VR device

Other

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.

Primary outcomes

  1. frequency of success

    Time frame: 30 minutes

    frequency of success (%) (use of emergency analgesics)

Secondary outcomes

  1. reduction of pain

    Time frame: 30 minutes

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

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

GANNOUN IMEN, ARC

CONTACT

[email protected]

73106000 ext. 216

NOUIRA Semir, PR

CONTACT

[email protected]

73106000 ext. 216

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: VR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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