Acute Pain, Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease
Conditions
Brief summary
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.
Detailed description
A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland. Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information, symptoms of the current illness and physical exam findings. Upon enrollment into the study, a study team member will interview the patient to collect data needed to complete the Case Report Form. Patients assigned to one of the two virtual reality study groups will be directed by research coordinators who can help with equipment as needed throughout the session. The virtual reality device will be limited to a maximum of 2 hours of use. Assessments will be made at 4 different timepoints: 1) Immediately before the intervention, 2) at the 1-hour mark of the intervention, 3) immediately after the intervention, and 4) 1 hour after the intervention. During these assessments, patients will rate their pain intensity using a 0-10 numerical scale. Additionally, at each assessment, patients will be asked to state the change in pain that has taken place since the last measurement. This measurement will be performed without informing the patient of their previously recorded pain scores. Data will also be recorded regarding the patient's 1) comfort of the device, 2) disposition (discharged home vs observation/admission status), 3) total length of treatment time in the ED (measured as time to initiation of any treatment to the time of final disposition), and 4) total amount of opioids administered while under the care of the emergency department clinicians, converted into morphine milligram equivalents. Each patient will complete a questionnaire at the conclusion of the session regarding their perceived impact of the intervention, ease of use, and likelihood to reuse the intervention.
Interventions
DEVICEVirtual Reality Headset and Hand-Held Controllers
Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
OTHERBlindfolding and Noise Cancelling
Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Once the participant has been enrolled in the study, they will be randomized to either the control arm or one of the experimental arms. No masking is being performed. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.
Intervention model description
This is a prospective, non-blinded, randomized clinical control trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Medical history of seizures or known intolerance to virtual reality * Disabilities like vision and hearing defects etc. that preclude the use of a head mounted virtual reality device. * Known to be pregnant * Incarcerated at the time of evaluation * Over the age of 89 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention. | A single time point 1 hour after the study intervention ends. | Patient reported on 0-10 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the proportion of subjects within each group who are hospitalized. | Day of enrollment | 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. | Day of enrollment | Measured in hours/minutes |
| Comparison of the subject's assessment of comfort of the study intervention between the 3 groups | Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends. | Patient reported on 1-5 Likert scale |
| Comparison of the change in pain scores between the 3 groups at one hour after study intervention begins. | A single time point 1 hour after the study intervention begins. | Patient reported on 0-10 scale |
| Comparison of the change in pain scores between the 3 groups at completion of the study intervention. | A single time point at the completion of the study intervention. | Patient reported on 0-10 scale |
| Comparison of the quantity opioids, converted to morphine milligram equivalents, administered while under the care of the ED clinical team. | Day of enrollment | Measured in morphine milligram equivalents |
Countries
United States
Contacts
Primary ContactR. Gentry Wilkerson, MD
Outcome results
None listed