Sickle Cell DiseaseNCT03353584
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
A study testing Virtual Reality Therapy in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by St. Jude Children's Research Hospital at 2 sites in United States.
Trial summary
Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for… Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis
- What is being tested?
- Virtual Reality Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2018to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant must have sickle cell disease (any genotype), documented in the St. Jude medical record.
- Participant must be seeking care for acute VOC pain at St. Jude Children's Research Hospital.
- Participant age must be ≥ 6 years and ≤ 25 years.
- English speaking
Who cannot join
- Prior randomization in this study.
- Patients are currently enrolled on another pain management interventional trial for the presenting pain crisis.
- Mild pain (score <4), or pain for which treatment with opioid is not indicated.
- Pain in combination with other clinical symptoms that require additional interventions, including fever with focus, acute chest syndrome, acute injury, or splenic sequestration.
- Developmental or psychiatric disorders like autism, claustrophobia or other disabilities like vision and hearing defects etc. that preclude the use of a head mounted device.
- Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
Methodist Comprehensive Sickle Cell Center
Memphis, Tennessee, 38104
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Michael Frett, MD, 888-226-4343, referralinfo@stjude.org
Michael Frett, MD
About this study
Official title: Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology
Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for patients with sickle cell disease who are experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to receive either standard management only or standard management in addition to virtual reality therapy. The remainder of care for the painful event will continue per institutional standards according to clinical indication, including reassessment and documentation of pain and additional doses of pain medicines by intravenous (IV) or oral route. Pain scores and opioid requirement will be measured and compared across treatment arms, along with the outcomes of discharge from clinic versus admission to the inpatient unit.
PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR arms, between the first pain assessment at the time of presentation and the subsequent pain assessments up to 30 minutes after intervention.
Read more
Secondary Objectives:
- To compare total opioid consumption from the time of presentation to the time of discharge from acute care setting in Standard versus VR arms.
- To assess the efficacy of virtual reality (VR) technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completion VR during an acute vaso-occlusive crisis in patients with sickle cell disease.
Read the detailed description
After consenting to participate in this study, patients will be randomized to receive either standard care therapy for VOC or to receive standard care therapy plus a 15-minute virtual reality (VR) session. They will be additionally randomized into strata by age: 6 to 11 years, 12 to 18 years, and 19 to 25 years. At the end of therapy or therapy plus the VR session, they will be asked to complete a 5-minute satisfaction survey. Information will also be collected from the medical record about the pain episode, including pain scores, medicines used, and time needed for pain to lessen.
Standard care for management of an acute VOC includes parenteral hydration and pain management with non-steroidal anti-inflammatory agents, such as Toradol or Ibuprofen, and opioids. Pain scores will be measured at three different time points: baseline at presentation, at 30±10 minutes after first intravenous (IV) analgesic medication, and at 60±10 minutes after first IV analgesic medication.
Use of VR will be included in addition to the standard care for management of patients randomized to VR arm. VR is an interactive technology that allows the user to interface with a three dimensional computer-generated environment by means of a lightweight head mounted display. The user is transported into a relaxing VR environment that diverts their attention away from pain. The duration of VR session is 15 minutes. Pain scores will be measured at three different time points: baseline at presentation, at 15±10 minutes after completion of VR therapy, and at 60±10 minutes after completion of VR therapy.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- Virtual Reality Therapy
- Keywords
- Virtual reality, Pain, Nonpharmacological
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TherapyOther
Also called VR therapy
The VR intervention consists of an interactive audio and visual underwater experience designed to serve as a calming distraction activity. The VR software (Kind VR® Aqua) was developed by KindVR specifically for the purpose of pain distraction in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age. |
| Virtual Reality | Active comparator | Participants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age. Receives: Other: Virtual Reality Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
The highest pain score based on all scores at different body pain locations is used as the pain score. The changes in pain scores in two arms between baseline and 30 minutes post study intervention will be summarized and compared using Wilcoxon rank sum test at a significance level of 0.1.
Measured: Baseline and up to 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start5 Feb 2018
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Frett, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353584
- Sponsor's protocol ID
- PMVOCVR
- Status last verified
- May 2026
- First submitted
- 21 Nov 2017
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology
- ClinicalTrials.gov ID
- NCT03353584
- Acronym / sponsor ID
- PMVOCVR
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Keywords
- Virtual reality, Pain, Nonpharmacological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for patients with sickle cell disease who are experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to receive either standard management only or standard management in addition to virtual reality therapy. The remainder of care for the painful event will continue per institutional standards according to clinical indication, including reassessment and documentation of pain and additional doses of pain medicines by intravenous (IV) or oral route. Pain scores and opioid requirement will be measured and compared across treatment arms, along with the outcomes of discharge from clinic versus admission to the inpatient unit.
PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR arms, between the first pain assessment at the time of presentation and the subsequent pain assessments up to 30 minutes after intervention.
Secondary Objectives:
- To compare total opioid consumption from the time of presentation to the time of discharge from acute care setting in Standard versus VR arms.
- To assess the efficacy of virtual reality (VR) technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completion VR during an acute vaso-occlusive crisis in patients with sickle cell disease.
Detailed description
After consenting to participate in this study, patients will be randomized to receive either standard care therapy for VOC or to receive standard care therapy plus a 15-minute virtual reality (VR) session. They will be additionally randomized into strata by age: 6 to 11 years, 12 to 18 years, and 19 to 25 years. At the end of therapy or therapy plus the VR session, they will be asked to complete a 5-minute satisfaction survey. Information will also be collected from the medical record about the pain episode, including pain scores, medicines used, and time needed for pain to lessen.
Standard care for management of an acute VOC includes parenteral hydration and pain management with non-steroidal anti-inflammatory agents, such as Toradol or Ibuprofen, and opioids. Pain scores will be measured at three different time points: baseline at presentation, at 30±10 minutes after first intravenous (IV) analgesic medication, and at 60±10 minutes after first IV analgesic medication.
Use of VR will be included in addition to the standard care for management of patients randomized to VR arm. VR is an interactive technology that allows the user to interface with a three dimensional computer-generated environment by means of a lightweight head mounted display. The user is transported into a relaxing VR environment that diverts their attention away from pain. The duration of VR session is 15 minutes. Pain scores will be measured at three different time points: baseline at presentation, at 15±10 minutes after completion of VR therapy, and at 60±10 minutes after completion of VR therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age. |
| Virtual Reality | Active comparator | Other: Virtual Reality TherapyParticipants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participant must have sickle cell disease (any genotype), documented in the St. Jude medical record.
- Participant must be seeking care for acute VOC pain at St. Jude Children's Research Hospital.
- Participant age must be ≥ 6 years and ≤ 25 years.
- English speaking
Key exclusion criteria (6 listed)
- Prior randomization in this study.
- Patients are currently enrolled on another pain management interventional trial for the presenting pain crisis.
- Mild pain (score <4), or pain for which treatment with opioid is not indicated.
- Pain in combination with other clinical symptoms that require additional interventions, including fever with focus, acute chest syndrome, acute injury, or splenic sequestration.
- Developmental or psychiatric disorders like autism, claustrophobia or other disabilities like vision and hearing defects etc. that preclude the use of a head mounted device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TherapyAlso: VR therapyThe VR intervention consists of an interactive audio and visual underwater experience designed to serve as a calming distraction activity. The VR software (Kind VR® Aqua) was developed by KindVR specifically for the purpose of pain distraction in a hospital setting. | Other | Virtual Reality |
Primary outcome
Change in pain scores
Time frame: Baseline and up to 30 minutes after intervention
The highest pain score based on all scores at different body pain locations is used as the pain score. The changes in pain scores in two arms between baseline and 30 minutes post study intervention will be summarized and compared using Wilcoxon rank sum test at a significance level of 0.1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Frett, MD principal investigator
St. Jude Children's Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by St. Jude Children's Research Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Frett, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: Baseline and up to 30 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.