Sickle Cell DiseaseNCT06184126
Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
A study testing Blindfolding and Noise Cancelling in people with Sickle Cell Disease and Vaso-occlusive Pain Episode in Sickle Cell Disease, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Acute Pain
- What is being tested?
- Blindfolding and Noise Cancelling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Known to be pregnant
- Incarcerated at the time of evaluation
- Over the age of 89 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Medical Systems
Baltimore, Maryland, 21201
R. Gentry Wilkerson, MD, 410-328-4237, gwilkerson@som.umaryland.edu
About this study
Official title: Pilot Study to Investigate the Use of Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
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.
Read the 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.
- Being tested
- Virtual Reality Headset and Hand-Held Controllers, Blindfolding and Noise Cancelling
- Medical subject headings
- Anemia, Sickle Cell, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Headset and Hand-Held ControllersDevice
Also called Meta Quest 2
Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
Blindfolding and Noise CancellingOther
Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality Headset and Hand-Held Controllers |
| 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. Receives: Device: Virtual Reality Headset and Hand-Held Controllers |
| 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. Receives: Other: Blindfolding and Noise Cancelling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: A single time point 1 hour after the study intervention ends.
Secondary outcomes (6)
Comparison of the subject's assessment of comfort of the study intervention between the 3 groups
Patient reported on 1-5 Likert scale
Measured: 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.
Determine whether the patient is discharged home vs. placed in observation/admission status after completion of emergency department care.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: A single time point at the completion of the study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, non-blinded, randomized clinical control trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Gentry Wilkerson, University of Maryland, Baltimore
- Investigators
- R. Gentry Wilklerson, MD, Principal investigator, U of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184126
- Sponsor's protocol ID
- HP-00106992
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing any individual participant data with other researchers
Publications
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.
PubMed 30332562Jang 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.
PubMed 34544432Duroseau 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.
PubMed 34401866Osunkwo 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.
PubMed 33062233Williams 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.
PubMed 26596876Chuan 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.
PubMed 32720308Smith 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.
PubMed 33136055Agrawal 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.
PubMed 30362236Mercado 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.
PubMed 36752670