Pain, Acute
Conditions
Keywords
Virtual reality therapy, Pain at rest, Emergency department
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.
Interventions
DEVICEVirtual reality
Virtual reality based on distraction and Virtual Reality based on focussed attention
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS-Pain score at rest | throughout study participation, up to 8 hours | Pain score before and after administration of VR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| NRS anxiety scores | Measured every 30 minutes until discharge of patient to maximal 6 hours | Anxiety score before and after administration of VR |
| 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 |
| 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 |
Countries
Netherlands
Outcome results
None listed