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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
acute pijn door enige oorzaak
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
NRS scores of pain at rest, repeated
Secondary outcome
Anxiety
- NRS anxiety scores, repeated
Analgesics
- Oral Morphine Equivalent (OME)
- Administered analgesics at the ED and type
- Administered non-pharmacological analgesia (eg. casting, reduction of
fracture)
Patient reported outcome measures
- Acceptability of pain at discharge (yes/no)
- Patients desire for analgesics upon admittance and at discharge (yes/no)
- NRS immersion score
- Satisfaction with pain management (NRS-scale)
Process indicators
- Duration ED visit
Follow-up (diary)
- Analgesic prescriptions by emergency physician
Safety outcomes
- Reasons for withdrawal
- Adverse events during VR therapy
Barriers to implementation
- Technical problems
- Feedback on apps
Background summary
Analgesics prescriptions, especially opioids, have doubled in the Emergency
department (ED) over the past decades to control for frequently reported
undertreatment of pain in ED patients. Consequently, there is a shift towards
reduced used of opioids at the ED. However, there are still few
non-pharmacological alternatives.
Virtual Reality (VR) is a relatively new and promising technique in
non-pharmacologic pain reduction and anxiolysis. VR based on distraction (VRD)
is the most widely described form of VR therapy and shows positive results on
pain relief and reduces opioids use. VR based on focussed attention (VRF) is a
relatively new modality based on the principles of therapeutic communication,
which differs itself from distraction by the involved focussed attention and is
well described for pain management. We hypothesize that both VR is effective
for reducing pain scores and analgesics use at the ED.
Study 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.
Study design
Randomized controlled trial
Intervention
One group will receive usual care, the intervention group will receive VR,
being VR based on distraction or VR based on focussed attention.
Study burden and risks
Participants in the intervention groups may benefit in the form of improved
pain management and reduced anxiety, and they might need less pharmacologic
analgesia reducing the risk of side-effect from analgesics. The results from
this study will provide new insight in possible use of new non-pharmacological
pain management options in the ED. The risks for participants are negligible.
We expect no or only minimal adverse effects from the VR intervention.
Participants in the intervention group will not be withheld *usual* analgesia.
The burden of the participants associated with this study is related to the
measurement of endpoints, which will include every hour a few short questions
about pain experience and anxiety, and upon admittance and at discharge some
additional questions about patient characteristics, satisfaction, and
experience with the intervention.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
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 protocol
Exclusion criteria
- 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 opioid use (>=3 months)
- Psychiatric disorders interfering with patients* understanding of the study
protocol and informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84480.091.23 |