Virtual Reality Therapy for Pain Management at the Emergency Department (VRxOPUS-2)

Radboud University Medical Center

Status

Enrolling

Conditions

Pain, Acute

Treatments

Device: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT06089642

114609

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

16 to 99 years old

Volunteers

No Healthy Volunteers

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