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Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease

Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 25 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "At the end of therapy or therapy plus the VR session, they will be asked to complete a 5-minute satisfaction survey."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding virtual reality to usual pain care helps people with sickle cell disease during a sudden pain crisis. It is for English-speaking patients ages 6 to 25 seeking care at St. Jude Children's Research Hospital. Patients are assigned by chance to usual pain care alone or usual pain care plus virtual reality.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have any type of sickle cell disease recorded in your St. Jude medical record.
  • Be seeking care at St. Jude Children's Research Hospital for a sudden pain crisis caused by blocked blood flow.
  • Be 6 to 25 years old.
  • Speak English.

Who can't join

  • Have already been assigned to a treatment group in this study.
  • Be in another study testing pain treatment for the same pain crisis.
  • Have mild pain (a pain score below 4), or pain that does not need opioid medicine, a strong pain reliever.
  • Have other symptoms that need extra treatment, such as fever with a known source, acute chest syndrome (a serious lung problem), a new injury, or blood trapped in the spleen.
  • Have a condition that prevents use of a virtual reality headset, such as autism, fear of enclosed spaces, or vision or hearing problems.
  • You or your legal guardian or representative cannot or will not give written permission to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Study sites (2)

TN