Virtual Reality Therapy for Pain Management at the Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Therapy for Pain Management at the Emergency Department

Conditions
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Pain, Acute

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Virtual Reality therapy<br>Patients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two) | Device: Virtual reality<br>* Virtual reality based on distraction and Virtual Reality based on focussed attention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS-Pain score at rest | Pain score before and after administration of VR | throughout study participation, up to 8 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality therapy, Pain at rest, Emergency department