Botten en gewrichten fracture Joint dislocation
Conditions
Interventions
A Virtual Reality(VR) Head Mounted Display(HMD) with an additional wristband
photoplethysmography sensor will be applied in the intervention group, in
addition to the administration of paracetamol a
Sponsors
Elisabeth-Tweesteden ziekenhuis
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients aged >= 13 years in the ED undergoing fracture or joint reduction and do not require procedural sedation and analgesia.
Exclusion criteria
Exclusion criteria: - Preprocedural use of opioids or sedatives. - Patients with epilepsy - Patients with migraine - Patient with dementia - Patients who are intoxicated (alcohol, drugs or other) - Patients with cognitive impairment - Patients with injuries to the eyes, face, neck that prevent comfortable use of VR headset - Patients with a language barrier where it is not possible to get informed consent and/or provide proper instruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity will be assessed using a standard numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain ever experienced), before, during and after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The GAD-7 will be used to assess anxiety in adults. Pain related fear in children will be assessed using the Children*s Fear Scale (CFS). Success of VR is defined as the ability to perform the procedure without the need for escape medication. All adverse events will be recorded. We will be assessing for cyber sickness using the 9-item Virtual Reality Sickness Questionnaire (VRSQ) [27]. We will measure satisfaction by using a standard numerical rating scale for both the patient and the physician, ranging from 0 (totally unsatisfied) to 10 (totally satisfied). Additionally, we will ask physicians to score the observed discomfort of patients on a NRS as well, ranging from 0 (no visible pain) to 10 (worst pain ever experienced). Finally, we will be investigating exploratory eye tracking data in response to procedural pain. We will measure pain by looking at the number of eye blinks, analyzing eye movement (saccades and fixation) as well as gaze direction shifts towards the hemifield of the operational site. Moreover, we will be recording heart rate variability as an additional biomarker to evaluate nociceptive response to the procedurally induced pain via the built in photoplethysmogram sensor of the VR headset. | — |
Countries
Netherlands
Outcome results
None listed