Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Headset and Hand-Held Controllers

    Device

    Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.

  • Blindfolding and Noise Cancelling

    Other intervention

    Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Active Immersive Virtual RealityExperimental treatment 1 intervention
Group B: Passive Immersive Virtual RealityExperimental treatment 1 intervention
Group C: Blindfold and Ear PlugsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
A single time point 1 hour after the study intervention ends.

Secondary outcomes

1

Comparison of the subject's assessment of comfort of the study intervention between the 3 groups

Patient reported on 1-5 Likert scale

Time frame
Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends.
2

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.

Time frame
Day of enrollment
3

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

Time frame
Day of enrollment
4

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

Time frame
Day of enrollment

Other outcomes

Sponsors and contacts

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