Virtual Reality Therapy for Pain Management at the Emergency Department

NCT06089642 | Unknown

• 1 other identifier: 114609
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Prescriptions of analgesics, especially opioids, have doubled in the Emergency department (ED) over the past decades in response to frequently reported undertreatment of pain in ED patients. Consequently, there is a shift towards a more restrained utilisation of opioids at the ED. However, there are still few (non-)pharmacological alternatives. Virtual Reality (VR) therapy is a relatively new and promising technique in non-pharmacologic pain reduction and anxiolysis and shows positive results on pain relief and pain. Objective: Primary objective is to investigate the effect of VR on patient-reported pain outcomes in the ED. Secondary objectives are to investigate the effect of VR on analgesics use, patient-reported outcomes, and process indicators and to identify barriers to implementation. Last, subanalyses will be performed to compare the effectiveness of two types of VR: VR based on distraction (VRD) and VR based on focussed attention (VRF). Study design: randomized controlled trial. Study population: Adults admitted to the ED with a NRS pain score of 4 (out of ten) or more and unacceptable pain. Intervention: There will be a control group receiving usual care and a intervention group that receives additional VR therapy. Main study parameters/endpoints: The main study outcome is the difference in patient-reported NRS pain score.

Conditions

Pain, Acute

Keywords

Virtual reality therapy; Pain at rest; Emergency department

Outcome Measures

Primary Outcomes (1)

• NRS-Pain score at rest

  Pain score before and after administration of VR

  throughout study participation, up to 8 hours

Secondary Outcomes (13)

• NRS anxiety scores

  Measured every 30 minutes until discharge of patient to maximal 6 hours

• Oral Morphine Equivalent (OME)

  throughout study participation, up to 8 hours

• Administered analgesics at the ED and type

  throughout study participation, up to 8 hours

• Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)

  throughout study participation, up to 8 hours

• Acceptability of pain at discharge (yes/no)

  Assessed at moment of discharge, up to 6 hours after inclusion

Study Arms (2)

Control

NO INTERVENTION

Usual care

Virtual Reality therapy

EXPERIMENTAL

Patients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two)

Device: Virtual reality

Interventions

Virtual reality DEVICE

Virtual reality based on distraction and Virtual Reality based on focussed attention

Virtual Reality therapy

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥16 years admitted to ED
• NRS pain at rest score ≥4
• Pain not acceptable for patient
• Patient is willing and able to comply with the study protoc

You may not qualify if:

• Patients initially treated by another physician than the emergency physician (EP).
• EMV \< 14
• History of dementia, seizures
• Severe hearing/visual impairment not corrected
• Headwounds or damaged skin with which comfortable and hygienic use is not possible.
• Presentation to the ED because of chronic pain (≥3 months) exacerbation
• Chronic opioid use (≥3 months)
• Psychiatric disorders interfering with patients' understanding of the study protocol and informed consent

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Acute Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 18, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)