Virtual Reality Therapy for Pain Management at the Emergency Department

Not Applicable

Recruiting

• Conditions: Pain, Acute
• Interventions: Device: Virtual reality

• Registration Number: NCT06089642
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-18
• Study Start: 2023-12-01
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
NRS-Pain score at rest	throughout study participation, up to 8 hours	Pain score before and after administration of VR

Secondary Outcome Measures

Name	Time	Method
Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)	throughout study participation, up to 8 hours	registered type of non-pharmacological analgesia adminstered during patients' stay at Emergency Department
Satisfaction with pain management	Assessed at moment of discharge, up to 6 hours after inclusion	Numeric rating scale to score satisfaction of patients with pain management
NRS immersion score	Assessed at moment of discharge, up to 6 hours after inclusion	Numeric rating score to measure how immersed patients felt in the VR world
Acceptability of pain at discharge (yes/no)	Assessed at moment of discharge, up to 6 hours after inclusion	Acceptability of pain at discharge (yes/no)
follow-up of patient	Assessed at moment of discharge, up to 6 hours after inclusion	registered whether patient is admitted to hospital, discharged home or discharged to other facility
NRS anxiety scores	Measured every 30 minutes until discharge of patient to maximal 6 hours	Anxiety score before and after administration of VR
Oral Morphine Equivalent (OME)	throughout study participation, up to 8 hours	Dose of morphines adminstered to a patient during their stay at the Emergency Department calculated in OME
Analgesics prescription by emergency physician	throughout study participation, up to 8 hours	type and dose of analgesics prescribed by emergency physician
Side effect during VR therapy	evaluated every 30 minutes up to max 6 hours	Open question
Patients desire for analgesics upon admittance and at discharge (yes/no)	Asked at moment of admittance and at discharge, up to 6 hours after inclusion	Patients desire for analgesics upon admittance and at discharge (yes/no)
Duration ED visit	throughout study participation, up to 8 hours	duration ED visit in hours
Interview one week after ED admission about patient experiences	approximately one week after ED admission	Interview one week after ED admission about patient experiences exploring barriers and facilitators to implementation
Administered analgesics at the ED and type	throughout study participation, up to 8 hours	registered type and total dose of analgesics administered to patient during the time they stayed at the Emergency Department

Trial Locations

Locations (1)

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands