Pain, AcuteVRxOPUS-2NCT06089642
Virtual Reality Therapy for Pain Management at the Emergency Department
A study testing Virtual reality in people with Pain, Acute, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Groenveld, MD, tjitske.groenveld@radboudumc.nl
About this study
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.
Read more
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
- Being tested
- Virtual reality
- Keywords
- Virtual reality therapy, Pain at rest, Emergency department
- Medical subject headings
- Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Virtual reality based on distraction and Virtual Reality based on focussed attention
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Virtual Reality therapy | Experimental | Patients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two) Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS-Pain score at rest
Pain score before and after administration of VR
Measured: throughout study participation, up to 8 hours
Secondary outcomes (13)
NRS anxiety scores
Anxiety score before and after administration of VR
Measured: Measured every 30 minutes until discharge of patient to maximal 6 hours
Oral Morphine Equivalent (OME)
Dose of morphines adminstered to a patient during their stay at the Emergency Department calculated in OME
Measured: throughout study participation, up to 8 hours
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
Measured: throughout study participation, up to 8 hours
Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)
registered type of non-pharmacological analgesia adminstered during patients' stay at Emergency Department
Measured: throughout study participation, up to 8 hours
Acceptability of pain at discharge (yes/no)
Acceptability of pain at discharge (yes/no)
Measured: Assessed at moment of discharge, up to 6 hours after inclusion
Patients desire for analgesics upon admittance and at discharge (yes/no)
Patients desire for analgesics upon admittance and at discharge (yes/no)
Measured: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
NRS immersion score
Numeric rating score to measure how immersed patients felt in the VR world
Measured: Assessed at moment of discharge, up to 6 hours after inclusion
Satisfaction with pain management
Numeric rating scale to score satisfaction of patients with pain management
Measured: Assessed at moment of discharge, up to 6 hours after inclusion
Duration ED visit
duration ED visit in hours
Measured: throughout study participation, up to 8 hours
follow-up of patient
registered whether patient is admitted to hospital, discharged home or discharged to other facility
Measured: Assessed at moment of discharge, up to 6 hours after inclusion
Analgesics prescription by emergency physician
type and dose of analgesics prescribed by emergency physician
Measured: throughout study participation, up to 8 hours
Side effect during VR therapy
Open question
Measured: evaluated every 30 minutes up to max 6 hours
Interview one week after ED admission about patient experiences
Interview one week after ED admission about patient experiences exploring barriers and facilitators to implementation
Measured: approximately one week after ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Dec 2023
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089642
- Sponsor's protocol ID
- 114609
- Acronym
- VRxOPUS-2
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Therapy for Pain Management at the Emergency Department
- ClinicalTrials.gov ID
- NCT06089642
- Acronym / sponsor ID
- VRxOPUS-2 / 114609
- Conditions
- Pain, Acute
- Keywords
- Virtual reality therapy, Pain at rest, Emergency department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Virtual Reality therapy | Experimental | Device: Virtual realityPatients receive virtual reality therapy in the form of active distraction or focussed attention (randomized between those two) |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityVirtual reality based on distraction and Virtual Reality based on focussed attention | Device | Virtual Reality therapy |
Primary outcome
NRS-Pain score at rest
Time frame: throughout study participation, up to 8 hours
Pain score before and after administration of VR
13 secondary outcomes
NRS anxiety scores
Time frame: Measured every 30 minutes until discharge of patient to maximal 6 hours
Oral Morphine Equivalent (OME)
Time frame: throughout study participation, up to 8 hours
Administered analgesics at the ED and type
Time frame: throughout study participation, up to 8 hours
Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)
Time frame: throughout study participation, up to 8 hours
Acceptability of pain at discharge (yes/no)
Time frame: Assessed at moment of discharge, up to 6 hours after inclusion
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
NRS immersion score
Time frame: Assessed at moment of discharge, up to 6 hours after inclusion
Satisfaction with pain management
Time frame: Assessed at moment of discharge, up to 6 hours after inclusion
Duration ED visit
Time frame: throughout study participation, up to 8 hours
follow-up of patient
Time frame: Assessed at moment of discharge, up to 6 hours after inclusion
Analgesics prescription by emergency physician
Time frame: throughout study participation, up to 8 hours
Side effect during VR therapy
Time frame: evaluated every 30 minutes up to max 6 hours
Interview one week after ED admission about patient experiences
Time frame: approximately one week after ED admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Yes. Data is available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Pain, Acute, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS-Pain score at rest (time frame: throughout study participation, up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.