PainVRxOPUS-1NCT06072950
Opioid Use and Predicting Factors at the Emergency Department
An observational study of Pain and Pain, Acute, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Background: Increasing opioid misuse is a worldwide problem. About 10% of opioid misusers are primarily exposed to opioids at the Emergency Department (ED). This study was conducted to determine the feasibility for a clinical trial investigating the effect of Virtual Reality therapy on opioid consumption at the ED. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Pain, Pain, Acute
- How many people
- 149 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2023to 4 Sep 2023
- Phase
- Observational
- 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
Study population: We aim to include all patients ≥16 years, who are admitted to the ED of the Radboudumc and primarily seen by an ED physician.
Who may be able to join
- Patient ≥16 years admitted to ED and identified by an Emergency Physician (EP)
- NRS pain score ≥4
- Patient is willing and able to comply with the study protocol
Who cannot join
- Patients initially treated by another physician than the 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 ED because of chronic pain (≥3 months) exacerbation
- Chronic opioids use (≥3 months)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
Background: Increasing opioid misuse is a worldwide problem. About 10% of opioid misusers are primarily exposed to opioids at the Emergency Department (ED). This study was conducted to determine the feasibility for a clinical trial investigating the effect of Virtual Reality therapy on opioid consumption at the ED.
Methods: Adult patients were included when primarily seen by the Emergency Physician and presenting with a NRS pain score ≥4. Main objective was to identify the target population and evaluate outcome measures to sustain a trial incorporating the Oral Morphine Equivalent (OME) at the ED as the primary endpoint. Primary outcome was mean OME administered at the ED. Secondary outcomes included NRS pain scores, main symptoms and type of analgesics administered at the ED.
- Conditions
- Pain, Pain, Acute
- Being tested
- Usual care
- Keywords
- Emergency Department, Pain at rest, Opioid use
- Medical subject headings
- Pain, Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Patients received usual care
| Study group | Role | What they receive |
|---|---|---|
| Patient with NRS pain at rest being 4 or higher | Patient with NRS pain at rest being 4 or higher, primarily treated by emergency physician, internist, or surgeon. All patients receive usual care, no interventions are administered. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
Opioids use of patients during their stay at Emergency Department (yes/no)
Measured: throughout study participation, up to 8 hours
Secondary outcomes (12)
Oral morphine equivalent
Doses of opioids received by a patient during their stay at the ED converted to Oral morphine equivalent (OME)
Measured: throughout study participation, up to 8 hours
Administered analgesics
Type and dose of all administered analgesics at Emergency Department.
Measured: throughout study participation, up to 8 hours
Pain acceptability
Patient opinion on acceptability of their pain at rest upon admittance and discharge
Measured: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
Reason why patients finds pain acceptable
Open question
Measured: Assessed upon admittance
Patients desire for analgesics
yes/no question whether patient desires analgesics
Measured: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
Patients openness to VR
yes/no question to explore patients willingeness to use VR in their situation
Measured: Assessed upon admittance
Numaric rating score pain scores at rest
Including whether this is pre/post analgesics
Measured: Every 30 minutes until discharge of patient
Numaric rating score anxiety scores
NRS anxiety scores
Measured: Every 30 minutes until discharge of patient
Satisfaction with pain management
On a numaric rating scale
Measured: Asked at moment of discharge, up to 6 hours after inclusion
Nurse opinion on patient adequacy of pain reporting
Categorical question: understating - adequate - exaggerating
Measured: Assessed upon admittance
Duration of ED visit
Duration of ED visit
Measured: throughout study participation, up to 8 hours
Analgesics prescriptions
When patient is discharged home prescribed analgesics are registered.
Measured: throughout study participation, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start13 Feb 2023
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
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
- NCT06072950
- Sponsor's protocol ID
- 113728
- Acronym
- VRxOPUS-1
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Use and Predicting Factors at the Emergency Department
- ClinicalTrials.gov ID
- NCT06072950
- Acronym / sponsor ID
- VRxOPUS-1 / 113728
- Conditions
- Pain, Pain, Acute
- Keywords
- Emergency Department, Pain at rest, Opioid use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 10 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.
Background: Increasing opioid misuse is a worldwide problem. About 10% of opioid misusers are primarily exposed to opioids at the Emergency Department (ED). This study was conducted to determine the feasibility for a clinical trial investigating the effect of Virtual Reality therapy on opioid consumption at the ED.
Methods: Adult patients were included when primarily seen by the Emergency Physician and presenting with a NRS pain score ≥4. Main objective was to identify the target population and evaluate outcome measures to sustain a trial incorporating the Oral Morphine Equivalent (OME) at the ED as the primary endpoint. Primary outcome was mean OME administered at the ED. Secondary outcomes included NRS pain scores, main symptoms and type of analgesics administered at the ED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with NRS pain at rest being 4 or higher | – | Other: Usual carePatient with NRS pain at rest being 4 or higher, primarily treated by emergency physician, internist, or surgeon. All patients receive usual care, no interventions are administered. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We aim to include all patients ≥16 years, who are admitted to the ED of the Radboudumc and primarily seen by an ED physician.
Key inclusion criteria (3 listed)
- Patient ≥16 years admitted to ED and identified by an Emergency Physician (EP)
- NRS pain score ≥4
- Patient is willing and able to comply with the study protocol
Key exclusion criteria (7 listed)
- Patients initially treated by another physician than the 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 |
|---|---|---|
| Usual carePatients received usual care | Other | Patient with NRS pain at rest being 4 or higher |
Primary outcome
Opioid use
Time frame: throughout study participation, up to 8 hours
Opioids use of patients during their stay at Emergency Department (yes/no)
12 secondary outcomes
Oral morphine equivalent
Time frame: throughout study participation, up to 8 hours
Administered analgesics
Time frame: throughout study participation, up to 8 hours
Pain acceptability
Time frame: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
Reason why patients finds pain acceptable
Time frame: Assessed upon admittance
Patients desire for analgesics
Time frame: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
Patients openness to VR
Time frame: Assessed upon admittance
Numaric rating score pain scores at rest
Time frame: Every 30 minutes until discharge of patient
Numaric rating score anxiety scores
Time frame: Every 30 minutes until discharge of patient
Satisfaction with pain management
Time frame: Asked at moment of discharge, up to 6 hours after inclusion
Nurse opinion on patient adequacy of pain reporting
Time frame: Assessed upon admittance
Duration of ED visit
Time frame: throughout study participation, up to 8 hours
Analgesics prescriptions
Time frame: throughout study participation, up to 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided. Data will be made 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use (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 10 Oct 2023.