Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 6 - 25 |
| Updated: | 6/13/2018 |
| Start Date: | February 5, 2018 |
| End Date: | February 2021 |
| Contact: | Latika Puri, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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.
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.
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.
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.
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.
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 or the Methodist Health system.
- 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.
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sites
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262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Latika Puri, MD
Phone: 866-278-5833
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