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Virtual Reality for SCD VOC

ConditionSickle Cell Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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 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.

Treatment groups

25 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Sham 2D, then Passive 3D VRExperimental treatment 2 interventions
Group B: Passive 3D VR → Sham 2DExperimental treatment 2 interventions
Group C: Sham 2D → Active 3D VRExperimental treatment 2 interventions
Group D: Active 3D VR → Sham 2DExperimental treatment 2 interventions
Group E: Passive 3D VR → Active 3D VRExperimental treatment 2 interventions
Group F: Active 3D VR → Passive 3D VRExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
60 minutes ± 10 minutes

Secondary outcomes

1

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

Pain durability will be assessed using participant-reported pain scores at 120 minutes after intervention start and change in pain score from baseline to 120 minutes. Pain will be measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst possible pain. The 120-minute pain assessment will be considered valid if obtained within the prespecified window of 100 to 140 minutes after intervention start. If the participant leaves the infusion center before this window, study staff will attempt to obtain an end-of-encounter pain score with the time recorded.

Time frame
120 minutes
2

Participant-Reported Immersion Rating Immediately After Headset Session

Perceived immersion will be assessed immediately after headset session completion or early discontinuation using a single participant-reported 0 to 10 rating scale in response to the question, "How immersive did the experience feel?" A score of 0 indicates not immersive at all, and a score of 10 indicates extremely immersive. Higher scores indicate greater perceived immersion.

Time frame
Immediately after headset session completion or early discontinuation
3

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

Acceptability will be assessed immediately after headset session completion or early discontinuation using a single participant-reported 0 to 10 rating scale in response to the question, "If available during future vaso-occlusive crisis treatment, how likely would you be to use this again?" A score of 0 indicates not at all likely, and a score of 10 indicates extremely likely. Higher scores indicate greater likelihood of future use.

Time frame
Immediately after headset session completion or early discontinuation
4

Opioid consumption during the first 60 minutes after intervention start

Opioid analgesic administration will be recorded from the medical record and summarized as morphine milligram equivalents during the first 60 minutes after intervention start.

Time frame
0 to 60 minutes after intervention start

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

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