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

Primary Purpose

Pain, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Virtual reality therapy, Pain at rest, Emergency department

Eligibility Criteria

16 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Radboud university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Virtual Reality therapy

Arm Description

Usual care

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

Outcomes

Primary Outcome Measures

NRS-Pain score at rest
Pain score before and after administration of VR

Secondary Outcome Measures

NRS anxiety scores
Anxiety score before and after administration of VR
Oral Morphine Equivalent (OME)
Dose of morphines adminstered to a patient during their stay at the Emergency Department calculated in OME
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
Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)
registered type of non-pharmacological analgesia adminstered during patients' stay at Emergency Department
Acceptability of pain at discharge (yes/no)
Acceptability of pain at discharge (yes/no)
Patients desire for analgesics upon admittance and at discharge (yes/no)
Patients desire for analgesics upon admittance and at discharge (yes/no)
NRS immersion score
Numeric rating score to measure how immersed patients felt in the VR world
Satisfaction with pain management
Numeric rating scale to score satisfaction of patients with pain management
Duration ED visit
duration ED visit in hours
follow-up of patient
registered whether patient is admitted to hospital, discharged home or discharged to other facility
Analgesics prescription by emergency physician
type and dose of analgesics prescribed by emergency physician
Side effect during VR therapy
Open question
Interview one week after ED admission about patient experiences
Interview one week after ED admission about patient experiences exploring barriers and facilitators to implementation

Full Information

First Posted
September 19, 2023
Last Updated
October 17, 2023
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06089642
Brief Title
Virtual Reality Therapy for Pain Management at the Emergency Department
Acronym
VRxOPUS-2
Official Title
Virtual Reality Therapy for Pain Management at the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
Virtual reality therapy, Pain at rest, Emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Virtual Reality therapy
Arm Type
Experimental
Arm Description
Patients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two)
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Virtual reality based on distraction and Virtual Reality based on focussed attention
Primary Outcome Measure Information:
Title
NRS-Pain score at rest
Description
Pain score before and after administration of VR
Time Frame
throughout study participation, up to 8 hours
Secondary Outcome Measure Information:
Title
NRS anxiety scores
Description
Anxiety score before and after administration of VR
Time Frame
Measured every 30 minutes until discharge of patient to maximal 6 hours
Title
Oral Morphine Equivalent (OME)
Description
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
Title
Administered analgesics at the ED and type
Description
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
Title
Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)
Description
registered type of non-pharmacological analgesia adminstered during patients' stay at Emergency Department
Time Frame
throughout study participation, up to 8 hours
Title
Acceptability of pain at discharge (yes/no)
Description
Acceptability of pain at discharge (yes/no)
Time Frame
Assessed at moment of discharge, up to 6 hours after inclusion
Title
Patients desire for analgesics upon admittance and at discharge (yes/no)
Description
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
Title
NRS immersion score
Description
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
Title
Satisfaction with pain management
Description
Numeric rating scale to score satisfaction of patients with pain management
Time Frame
Assessed at moment of discharge, up to 6 hours after inclusion
Title
Duration ED visit
Description
duration ED visit in hours
Time Frame
throughout study participation, up to 8 hours
Title
follow-up of patient
Description
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
Title
Analgesics prescription by emergency physician
Description
type and dose of analgesics prescribed by emergency physician
Time Frame
throughout study participation, up to 8 hours
Title
Side effect during VR therapy
Description
Open question
Time Frame
evaluated every 30 minutes up to max 6 hours
Title
Interview one week after ED admission about patient experiences
Description
Interview one week after ED admission about patient experiences exploring barriers and facilitators to implementation
Time Frame
approximately one week after ED admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is available upon reasonable request

Learn more about this trial

Virtual Reality Therapy for Pain Management at the Emergency Department

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