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

NCT06184126 | Recruiting

• 1 other identifier: HP-00106992
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaso-occlusive Pain Episode in Sickle Cell Disease; Sickle Cell Disease; Acute Pain

Outcome Measures

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

  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

  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.

  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.

  Day of enrollment

• Comparison of the quantity opioids, converted to morphine milligram equivalents, administered while under the care of the ED clinical team.

  Day of enrollment

• 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.

Study Arms (3)

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.

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.

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.

Other: Blindfolding and Noise Cancelling

Interventions

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.

Blindfold and Ear Plugs

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.

Also known as: Meta Quest 2

Active Immersive Virtual Reality; Passive Immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 30332562 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.

  PMID: 34544432 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.

  PMID: 34401866 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.

  PMID: 33062233 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.

  PMID: 26596876 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.

  PMID: 32720308 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.

  PMID: 33136055 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.

  PMID: 30362236 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.

  PMID: 36752670 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Acute Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• R. Gentry Wilklerson, MD

  U of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

R. Gentry Wilkerson, MD

CONTACT

410-328-4237; gwilkerson@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective, non-blinded, randomized clinical control trial.

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 28, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)