Clinical trial NCT03353584: Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Official title: Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Vaso-occlusive Crisis
Keywords: Virtual reality
Pain
Nonpharmacological
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

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.

Primary outcomes:
measure: Change in pain scores
timeFrame: Baseline and up to 30 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist Comprehensive Sickle Cell Center
state: Tennessee
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Michael Frett, MD
role: PRINCIPAL_INVESTIGATOR
References: