Virtual Reality Therapy for Pain Management at the Emergency Department

NCT ID: NCT06089642

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-04-01

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual Reality therapy

Patients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two)

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: DEVICE

Virtual reality based on distraction and Virtual Reality based on focussed attention

Interventions

Virtual reality

Virtual reality based on distraction and Virtual Reality based on focussed attention

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Groenveld, MD

Role: primary

tjitske.groenveld@radboudumc.nl

Other Identifiers

114609

Identifier Type: -

Identifier Source: org_study_id