Recruiting

VR Interventions

Sponsor:

University of Maryland, Baltimore

Code:

NCT07674277

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sham 2D Headset Control

Passive Immersive 3D Virtual Reality

Active Immersive Interactive 3D Virtual Reality

Study Details

Brief summary:

This randomized pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality (VR) interventions for adults with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC) treated in an infusion center. Up to 50 participants will be enrolled, provide informed consent, and undergo randomization during routine outpatient sickle cell clinic visits when they are clinically stable and not experiencing an acute VOC.

Using a randomized, two-period crossover design, each participant will be assigned to receive two of three headset-based interventions during separate qualifying infusion center visits for vaso-occlusive pain occurring within six months of enrollment: sham 2D headset control, passive immersive 3D VR, or active immersive interactive 3D VR. Each intervention will be delivered during a 45-minute session as an adjunct to usual clinical care.

The primary outcome is pain burden during the first 60 minutes after intervention start, measured as the 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 consumption, and participant-reported immersion and acceptability. Findings will inform the design of future trials evaluating VR as an adjunctive treatment for acute vaso-occlusive pain.

Conditions

Sickle Cell Disease

Study ID

NCT07674277

Start date

Nov 1, 2026

Status verified date

Oct, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Participants will be identified, screened, and consented during routine outpatient sickle cell disease clinic visits when they are clinically stable and not experiencing an acute vaso-occlusive crisis (VOC). Following enrollment, eligibility for each study intervention session will be confirmed during a qualifying VOC visit to the Stoler Infusion Center. Participants must meet the applicable clinical eligibility criteria and be receiving intravenous opioid treatment for acute vaso-occlusive pain at the time of the intervention visit.

\*\*Inclusion Criteria:\*\*

  • Adult patients aged 18 years or older.
  • History of sickle cell disease.
  • Treatment plan by the clinical care team includes intravenous opioids for acute pain.
  • Receiving treatment through the Stoler Infusion Center.

\*\*Exclusion Criteria:\*\*

  • Prior enrollment in this study.
  • Presentation with a chief complaint suggestive of a complicated vaso-occlusive crisis, including concern for acute chest syndrome, splenic sequestration, hepatic sequestration, or pulmonary embolism, as determined by the treating clinician.
  • Not receiving intravenous opioids for the vaso-occlusive crisis.
  • Inability to provide informed consent.
  • Medical history of seizures or known intolerance to virtual reality devices.
  • Preexisting visual or hearing impairments that, in the investigator's judgment, preclude use of a head-mounted virtual reality device.
  • Known pregnancy.
  • Incarceration at the time of evaluation.
  • Age greater than 88 years.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sham 2D, then Passive 3D VR

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.

experimental: Passive 3D VR → Sham 2D

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.

experimental: Sham 2D → Active 3D VR

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.

experimental: Active 3D VR → Sham 2D

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.

experimental: Passive 3D VR → Active 3D VR

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.

experimental: Active 3D VR → Passive 3D VR

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.

Interventions

Sham 2D Headset Control

The sham 2D headset control condition consists of non-interactive, two-dimensional nature-related video content displayed on a fixed virtual screen using the Meta Quest 2 headset platform. The content will be presented through the YouTube application and will depict natural environments similar to those used in the immersive VR conditions. Standardized audio will accompany the visual content. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. This condition serves as a headset-based control to maintain similar device exposure and attention across intervention conditions while minimizing immersion and interactivity.

Passive Immersive 3D Virtual Reality

The passive immersive 3D virtual reality condition consists of immersive three-dimensional visual content delivered through the Nature Treks application using the Meta Quest 2 headset platform. Participants will experience immersive natural environments with standardized audio and may look around 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. The intervention will be provided as an adjunct to usual clinical care.

Active Immersive Interactive 3D Virtual Reality

The active immersive interactive 3D virtual reality condition consists of immersive, interactive three-dimensional content delivered through the Nature Treks application using the Meta Quest 2 headset platform. Participants will experience immersive natural environments with standardized audio and interact with the virtual environment using handheld controllers while completing low-motion, seated activities. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. The intervention will be provided as an adjunct to usual clinical care.

Primary outcome measure

  • Pain burden during the first 60 minutes after intervention start [ Time Frame: 60 minutes ± 10 minutes ]

Central Contacts and Locations

Central contacts

Soowon Lee, MSPH

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

Rose Corcoran

2407439858rose.corcoran@som.umaryland.edu

Locations

University of Maryland Medical Center, Stoler Infusion Center

Recruiting

Baltimore, Maryland, United States, 21230

Contacts

R. Gentry Wilkerson, MD

410-328-4237GWilkerson@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.