Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Immersive Virtual Reality | Experimental | Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will participate in an active immersive application on the virtual reality headset with hand-held controllers. The active immersive application will allow the user to interact directly with the application and move through the virtual environment .The patient will be able to use the active immersive application on the device for a maximum of two hours. |
|
| Passive Immersive Virtual Reality | Experimental | Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will participate in a passive immersive application on the virtual reality headset with hand-held controllers. The passive immersive application will not allow the user to interact directly with the application or move through the virtual environment .The patient will be able to use the passive immersive application on the device for a maximum of two hours. |
|
| Blindfold and Ear Plugs | Placebo Comparator | Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will wear a blindfold and ear plugs. The patient will be able to remain blindfolded and earplugs for a maximum of two hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A single time point 1 hour after the study intervention ends. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the subject's assessment of comfort of the study intervention between the 3 groups | Patient reported on 1-5 Likert scale | Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends. |
| Comparison of the proportion of subjects within each group who are hospitalized. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R. Gentry Wilkerson, MD | Contact | 410-328-4237 | gwilkerson@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| R. Gentry Wilklerson, MD | U of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Systems | Recruiting | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30332562 | Background | Sundd P, Gladwin MT, Novelli EM. Pathophysiology of Sickle Cell Disease. Annu Rev Pathol. 2019 Jan 24;14:263-292. doi: 10.1146/annurev-pathmechdis-012418-012838. Epub 2018 Oct 17. | |
| 34544432 | Background | Jang T, Poplawska M, Cimpeanu E, Mo G, Dutta D, Lim SH. Vaso-occlusive crisis in sickle cell disease: a vicious cycle of secondary events. J Transl Med. 2021 Sep 20;19(1):397. doi: 10.1186/s12967-021-03074-z. |
Not provided
Not provided
We do not plan on sharing any individual participant data with other researchers
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, non-blinded, randomized clinical control trial.
Not provided
Not provided
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.
Not provided
|
| Blindfolding and Noise Cancelling | Other | Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices. |
|
Determine whether the patient is discharged home vs. placed in observation/admission status after completion of emergency department care. |
| Day of enrollment |
| 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 | Day of enrollment |
| 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 | Day of enrollment |
| Comparison of the change in pain scores between the 3 groups at one hour after study intervention begins. | Patient reported on 0-10 scale | A single time point 1 hour after the study intervention begins. |
| Comparison of the change in pain scores between the 3 groups at completion of the study intervention. | Patient reported on 0-10 scale | A single time point at the completion of the study intervention. |
| 34401866 | Background | Duroseau Y, Beenhouwer D, Broder MS, Brown B, Brown T, Gibbs SN, Jackson K, Liang S, Malloy M, Romney ML, Shani D, Simon J, Yermilov I. Developing an emergency department order set to treat acute pain in sickle cell disease. J Am Coll Emerg Physicians Open. 2021 Aug 7;2(4):e12487. doi: 10.1002/emp2.12487. eCollection 2021 Aug. |
| 33062233 | Background | Osunkwo I, Manwani D, Kanter J. Current and novel therapies for the prevention of vaso-occlusive crisis in sickle cell disease. Ther Adv Hematol. 2020 Sep 29;11:2040620720955000. doi: 10.1177/2040620720955000. eCollection 2020. |
| 26596876 | Background | Williams H, Tanabe P. Sickle Cell Disease: A Review of Nonpharmacological Approaches for Pain. J Pain Symptom Manage. 2016 Feb;51(2):163-77. doi: 10.1016/j.jpainsymman.2015.10.017. Epub 2015 Nov 17. |
| 32720308 | Background | Chuan A, Zhou JJ, Hou RM, Stevens CJ, Bogdanovych A. Virtual reality for acute and chronic pain management in adult patients: a narrative review. Anaesthesia. 2021 May;76(5):695-704. doi: 10.1111/anae.15202. Epub 2020 Jul 27. |
| 33136055 | Background | Smith V, Warty RR, Sursas JA, Payne O, Nair A, Krishnan S, da Silva Costa F, Wallace EM, Vollenhoven B. The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review. J Med Internet Res. 2020 Nov 2;22(11):e17980. doi: 10.2196/17980. |
| 30362236 | Background | Agrawal AK, Robertson S, Litwin L, Tringale E, Treadwell M, Hoppe C, Marsh A. Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Pediatr Blood Cancer. 2019 Feb;66(2):e27525. doi: 10.1002/pbc.27525. Epub 2018 Oct 26. |
| 36752670 | Background | Mercado SH. An outpatient pain plan and ED pain pathway for adults with sickle cell disease. JAAPA. 2023 Mar 1;36(3):20-23. doi: 10.1097/01.JAA.0000920956.33631.26. |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided