An interventional study of Virtual reality in Pain, Acute, sponsored by Radboud University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 124 is below the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Usual care
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
NRS-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
Plan to share: Yes — Data is available upon reasonable request
Supporting information: Study protocol
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Radboud University Medical Center