Virtual Reality Therapy for Pain Management at the Emergency Department

Pain, Acute Clinical Trial

— VRxOPUS-2  

Official title:

Virtual Reality Therapy for Pain Management at the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089642
• Other study ID #: 114609
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: September 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Pain, Acute

Intervention

Device:
• Virtual reality
Virtual reality based on distraction and Virtual Reality based on focussed attention

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS-Pain score at rest	Pain score before and after administration of VR	throughout study participation, up to 8 hours
Secondary	NRS anxiety scores	Anxiety score before and after administration of VR	Measured every 30 minutes until discharge of patient to maximal 6 hours
Secondary	Oral Morphine Equivalent (OME)	Dose of morphines adminstered to a patient during their stay at the Emergency Department calculated in OME	throughout study participation, up to 8 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration ED visit	duration ED visit in hours	throughout study participation, up to 8 hours
Secondary	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
Secondary	Analgesics prescription by emergency physician	type and dose of analgesics prescribed by emergency physician	throughout study participation, up to 8 hours
Secondary	Side effect during VR therapy	Open question	evaluated every 30 minutes up to max 6 hours
Secondary	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