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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | Virtual reality based on distraction and Virtual Reality based on focussed attention |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS-Pain score at rest | Pain score before and after administration of VR | throughout study participation, up to 8 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
Data is available upon reasonable request
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |