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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Virtual reality based on distraction and Virtual Reality based on focussed attention
Radboud university medical center
Nijmegen, Gelderland, Netherlands
RECRUITINGNRS-Pain score at rest
Pain score before and after administration of VR
Time frame: throughout study participation, up to 8 hours
NRS anxiety scores
Anxiety score before and after administration of VR
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: throughout study participation, up to 8 hours
Acceptability of pain at discharge (yes/no)
Acceptability of pain at discharge (yes/no)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Assessed at moment of discharge, up to 6 hours after inclusion
Duration ED visit
duration ED visit in hours
Time frame: 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
Time frame: 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
Time frame: throughout study participation, up to 8 hours
Side effect during VR therapy
Open question
Time frame: 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
Time frame: approximately one week after ED admission
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