Clinical trial NCT06089642: Virtual Reality Therapy for Pain Management at the Emergency Department
Official title: Virtual Reality Therapy for Pain Management at the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Acute
Keywords: Virtual reality therapy
Pain at rest
Emergency department
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 124
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: NRS-Pain score at rest
timeFrame: throughout study participation, up to 8 hours
Secondary outcomes:
measure: NRS anxiety scores
timeFrame: Measured every 30 minutes until discharge of patient to maximal 6 hours
measure: Oral Morphine Equivalent (OME)
timeFrame: throughout study participation, up to 8 hours
measure: Administered analgesics at the ED and type
timeFrame: throughout study participation, up to 8 hours
measure: Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)
timeFrame: throughout study participation, up to 8 hours
measure: Acceptability of pain at discharge (yes/no)
timeFrame: Assessed at moment of discharge, up to 6 hours after inclusion
measure: Patients desire for analgesics upon admittance and at discharge (yes/no)
timeFrame: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
measure: NRS immersion score
timeFrame: Assessed at moment of discharge, up to 6 hours after inclusion
measure: Satisfaction with pain management
timeFrame: Assessed at moment of discharge, up to 6 hours after inclusion
measure: Duration ED visit
timeFrame: throughout study participation, up to 8 hours
measure: follow-up of patient
timeFrame: Assessed at moment of discharge, up to 6 hours after inclusion
measure: Analgesics prescription by emergency physician
timeFrame: throughout study participation, up to 8 hours
measure: Side effect during VR therapy
timeFrame: evaluated every 30 minutes up to max 6 hours
measure: Interview one week after ED admission about patient experiences
timeFrame: approximately one week after ED admission
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: