Virtual Reality for SCD VOC

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

Interventions

DEVICE

Sham 2D Headset Control

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.

DEVICE

Passive Immersive 3D Virtual Reality

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.

DEVICE

Active Immersive Interactive 3D Virtual Reality

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.

Sponsors & Collaborators

• University of Maryland, Baltimore

  lead OTHER

Principal Investigators

• Richard G Wilkerson, MD · Unversity of Maryland School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-08-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations