VRxOPUS-2: Virtual Reality Therapy for Pain Management at the Emergency Department
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Usual care |
|
| Experimental: Virtual Reality therapy Patients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two) |
Device: Virtual reality
Virtual reality based on distraction and Virtual Reality based on focussed attention
|
Outcome Measures
Primary Outcome Measures
- NRS-Pain score at rest [throughout study participation, up to 8 hours]
Pain score before and after administration of VR
Secondary Outcome Measures
- 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
- 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
- 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
- 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)
- 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)
- 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
- 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
- Duration ED visit [throughout study participation, up to 8 hours]
duration ED visit in hours
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient ≥16 years admitted to ED
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NRS pain at rest score ≥4
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Pain not acceptable for patient
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Patient is willing and able to comply with the study protoc
Exclusion Criteria:
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Patients initially treated by another physician than the emergency physician (EP).
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EMV < 14
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History of dementia, seizures
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Severe hearing/visual impairment not corrected
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Headwounds or damaged skin with which comfortable and hygienic use is not possible.
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Presentation to the ED because of chronic pain (≥3 months) exacerbation
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Chronic opioid use (≥3 months)
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Psychiatric disorders interfering with patients' understanding of the study protocol and informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboud university medical center | Nijmegen | Gelderland | Netherlands | 6525 GA |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 114609