Clinical trial NCT05864092: Virtual Reality as an Adjuvant Therapy for Sickle Cell Vaso-Occlusive Crisis in the Pediatric Emergency Department
Official title: Virtual Reality as an Adjuvant Therapy for Sickle Cell Vaso-Occlusive Crisis in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Crisis
Keywords: Virtual Reality
Sickle Cell Crisis
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The study has two separate arms. A control arm will be a retrospective chart analysis of patients (100 anticipated) ages 6-21 with sickle cell VOC, and the trial arm will be an interventional prospective convenience sampling of patients (100 anticipated) admitted to the emergency department ages 6-21 with sickle cell VOC who will receive VR in addition to standard medical therapy.
Primary purpose: TREATMENT

Brief summary: Vaso-occlusive crisis (VOC) is the most common complaint in patients with sickle cell disease presenting to the emergency room. VOC is most commonly treated with opioids and NSAIDs. However, new research is demonstrating that opioids in addition to virtual reality (VR) is more effective at reducing the experience of pain and pain nerve signals compared to opioids alone. Numerous research studies have demonstrated that VR reduces the experience of pain during painful medical procedures in children, such as venipuncture and burn wound dressing changes.

The study aims to add VR to standard of care medical treatment for pediatric patients with sickle cell disease who present to the pediatric emergency department in VOC. Investigators will conduct a retrospective chart review of patients aged 6 to 21 years with sickle cell disease who present to the pediatric emergency department with VOC for the historical control arm. Investigators will also conduct a prospective convenient sampling of patient who receive VR plus standard medical care in patients aged 6 to 21years with sickle cell disease who present to the emergency department with VOC. Investigators hypothesize that VR, in addition to standard medical care, will reduce the experience of pain and hospital admissions compared to the historical control group (standard medical treatment).

Detailed description: Aim 1: To examine the effectiveness of VR plus standard medical therapy in reducing the experience of pain in patients 6 to 21 years with sickle cell VOC who present to the emergency department (ED), compared to historical standard medical care alone. Hypothesis 1: Patients who receive VR in addition to standard medical therapy will report lower pain severity when compared to historical control patients who received standard medical therapy alone.

Aim 2: To examine the effectiveness of VR plus standard medical therapy in reducing hospital admission rates for patients 6 to 21 years with sickle cell VOC who present to the ED, compared to historical standard medical therapy alone. Hypothesis 2: Patients who receive VR in addition to standard medical therapy will have a decreased rate of admission to the hospital compared to historical control patients who received standard medical therapy alone.

Secondary Aim 1: To examine the effectiveness of VR plus standard medical therapy in reducing length of stay in the ED Secondary Hypothesis 1: Patients who receive VR plus standard medical therapy will have shorter stays in the ED when compared to historical control patients who received standard medical therapy alone.

Secondary Aim 2: To examine the effectiveness of VR plus standard medical therapy in reducing time to ED disposition. Secondary Hypothesis 2: Patients who receive VR plus standard medical therapy will have shorter time to ED disposition when compared to historical control patients who received standard medical therapy alone.

Eligibility criteria: Inclusion Criteria:

1. Age of 6 to 21 years
2. Sickle cell disease, any genotype
3. Diagnosis of VOC
4. Pain score of 4 or greater

Exclusion Criteria:

1. Non-VOC pain (from acute illness or injury)
2. Fever
3. Respiratory distress or acute chest syndrome or cough
4. Complaints of headache/dizziness/nausea during visit
5. History of epilepsy or seizures

Primary outcomes:
measure: Pain Scores
timeFrame: Pain scores will be measured during patient stay in the ED. This is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 min.
measure: Patient Disposition
timeFrame: Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Secondary outcomes:
measure: Length of Stay in the Emergency Department
timeFrame: Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
measure: Time to Emergency Department Disposition
timeFrame: Time frame is variable based on patient treatment course. For the trial arm, virtual reality therapy and time study team will interact with the patient is estimated to be 30 minutes.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Matthew Maready, MD
role: PRINCIPAL_INVESTIGATOR
References:
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