About this trial
This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (age > 18 years) emergency department patient
History of sickle cell disease
Presenting to the emergency department due to acute pain related to sickle cell disease thought to be due to vaso-occlusive crisis
Disqualifiers
Prior enrollment in this study
Presenting with a chief complaint suggestive of a complicated crisis (such as concern for acute chest syndrome, splenic sequestration, hepatic sequestration, pulmonary embolism) as determined by the clinical care provider
Not being treated with intravenous opioids for the vaso-occlusive crisis
Patients who lack the capacity to provide informed consent
Trial design
Parallel
Treatments tested in this trial
Virtual Reality Headset and Hand-Held Controllers
DeviceStudy Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
Blindfolding and Noise Cancelling
Other interventionControl group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention.
Patient reported on 0-10 scale
Secondary outcomes
Comparison of the subject's assessment of comfort of the study intervention between the 3 groups
Patient reported on 1-5 Likert scale
Comparison of the proportion of subjects within each group who are hospitalized.
Determine whether the patient is discharged home vs. placed in observation/admission status after completion of emergency department care.
Compare the total duration of Emergency Department treatment measured from the time of delivery of the first intervention to the time of disposition.
Measured in hours/minutes
Comparison of the quantity opioids, converted to morphine milligram equivalents, administered while under the care of the ED clinical team.
Measured in morphine milligram equivalents
Sponsors and contacts
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