Virtual Reality for SCD VOC

NCT07674277 | Not Yet Recruiting FDA Device

• 1 other identifier: HP-00119171
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality interventions for adults with sickle cell disease experiencing vaso-occlusive crisis treated in an infusion center. Participants will be enrolled during routine outpatient sickle cell clinic visits and may receive study interventions during future qualifying infusion center visits for vaso-occlusive pain. Using a randomized, two-period crossover design, each participant will be assigned to receive two of three headset-based conditions across separate visits: sham 2D headset control, passive immersive 3D virtual reality, or active immersive interactive 3D virtual reality. The primary outcome is pain burden during the first 60 minutes after intervention start, measured as area under the curve of 0-10 numeric rating scale pain scores. Secondary outcomes include feasibility of intervention delivery, headset tolerability, pain at 120 minutes, opioid use, and participant-reported immersion and acceptability.

Conditions

Sickle Cell Disease

Keywords

virtual reality (VR); Sickle Cell Disease; vaso-occlusive crisis

Outcome Measures

Primary Outcomes (1)

• Pain burden during the first 60 minutes after intervention start

  Pain burden will be measured as the area under the curve from 0 to 60 minutes of participant-reported pain scores using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores will be collected at baseline before intervention start and at 15, 30, 45, and 60 minutes after intervention start. Area under the curve will be calculated using the trapezoidal rule with actual recorded assessment times.

  60 minutes ± 10 minutes

Secondary Outcomes (8)

• Pain at 120 minutes after intervention start (Durability of effect)

  120 minutes

• Participant-Reported Immersion Rating Immediately After Headset Session

  Immediately after headset session completion or early discontinuation

• Participant-Reported Likelihood of Future Use Rating Immediately After Headset Session

  Immediately after headset session completion or early discontinuation

• Opioid consumption during the first 60 minutes after intervention start

  0 to 60 minutes after intervention start

• Opioid consumption during the first 120 minutes after intervention start

  0 to 120 minutes after intervention start

Study Arms (6)

Sham 2D, then Passive 3D VR

EXPERIMENTAL

Participants randomized to this sequence will receive the sham 2D headset control condition during the first qualifying vaso-occlusive crisis infusion center visit and the passive immersive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction.

Device: Sham 2D Headset Control; Device: Passive Immersive 3D Virtual Reality

Passive 3D VR → Sham 2D

EXPERIMENTAL

Participants randomized to this sequence will receive the passive immersive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the sham 2D headset control condition during the second qualifying vaso-occlusive crisis infusion center visit. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio.

Device: Sham 2D Headset Control; Device: Passive Immersive 3D Virtual Reality

Sham 2D → Active 3D VR

EXPERIMENTAL

Participants randomized to this sequence will receive the sham 2D headset control condition during the first qualifying vaso-occlusive crisis infusion center visit and the active immersive interactive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction.

Device: Sham 2D Headset Control; Device: Active Immersive Interactive 3D Virtual Reality

Active 3D VR → Sham 2D

EXPERIMENTAL

Participants randomized to this sequence will receive the active immersive interactive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the sham 2D headset control condition during the second qualifying vaso-occlusive crisis infusion center visit. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio.

Device: Sham 2D Headset Control; Device: Active Immersive Interactive 3D Virtual Reality

Passive 3D VR → Active 3D VR

EXPERIMENTAL

Participants randomized to this sequence will receive the passive immersive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the active immersive interactive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction.

Device: Passive Immersive 3D Virtual Reality; Device: Active Immersive Interactive 3D Virtual Reality

Active 3D VR → Passive 3D VR

EXPERIMENTAL

Participants randomized to this sequence will receive the active immersive interactive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the passive immersive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction.

Device: Passive Immersive 3D Virtual Reality; Device: Active Immersive Interactive 3D Virtual Reality

Interventions

Sham 2D Headset Control DEVICE

The sham 2D headset control condition consists of non-interactive two-dimensional visual content displayed on a fixed virtual screen using the Meta Quest headset platform. Standardized audio will be provided during the session. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. This condition is intended to serve as a headset-based control while maintaining similar attention and device exposure across study conditions.

Active 3D VR → Sham 2D; Passive 3D VR → Sham 2D; Sham 2D → Active 3D VR; Sham 2D, then Passive 3D VR

Passive Immersive 3D Virtual Reality DEVICE

The passive immersive 3D virtual reality condition consists of 360-degree or three-dimensional immersive visual content delivered using the Meta Quest headset platform with standardized audio. Participants may look around within the virtual environment but will not interact with the content using controllers. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit.

Active 3D VR → Passive 3D VR; Passive 3D VR → Active 3D VR; Passive 3D VR → Sham 2D; Sham 2D, then Passive 3D VR

Active Immersive Interactive 3D Virtual Reality DEVICE

The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content delivered using the Meta Quest headset platform with standardized audio. Participants will interact with the virtual environment using controllers while completing low-motion, seated modules. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit.

Active 3D VR → Passive 3D VR; Active 3D VR → Sham 2D; Passive 3D VR → Active 3D VR; Sham 2D → Active 3D VR

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥ 18 years) patients
• History of sickle cell disease
• Treatment plan by clinical care team includes the use of intravenous opioids to -treat acute pain.
• Receiving treatment from the Stoler Infusion center

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 devices
• In the opinion of the investigator and based on chart review and direct questioning of the patient, there are preexisting disabilities like vision and hearing defects 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 Center, Stoler Infusion Center

Baltimore, Maryland, 21230, United States

Location

Related Publications (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

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

Study Officials

• Richard G Wilkerson, MD

  Unversity of Maryland School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soowon Lee, MSPH

CONTACT

254-400-4894; Soowon.Lee@som.umaryland.edu

Rose Corcoran

CONTACT

2407439858; rose.corcoran@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, University of Maryland School of Medicine Department of Emergency Medicine Director of Clinical Research, University of Maryland School of Medicine Department of Emergency Medicine Assistant Residency Program Director

Model Details: Participants will be randomized to receive two of three headset-based intervention conditions across two separate qualifying vaso-occlusive crisis infusion center visits using a balanced incomplete block crossover design. The three possible intervention pairs are sham 2D headset control plus passive immersive 3D virtual reality, sham 2D headset control plus active immersive interactive 3D virtual reality, or passive immersive 3D virtual reality plus active immersive interactive 3D virtual reality. Within each pair, the order of the two assigned interventions will be randomized.

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)