Virtual Reality as an Adjuvant Therapy for Sickle Cell Vaso-Occlusive Crisis in the Pediatric Emergency Department

University of Mississippi

Status: Completed

Conditions: Sickle Cell Crisis

Treatments: Other: Virtual Reality Goggles

Study type: Interventional

Funder types: Other

Identifiers

NCT05864092

UMMC-IRB-2023-8

Details and patient eligibility

About

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).

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

101 participants in 2 patient groups

Control Arm

No Intervention group

Description:

The control arm will be a retrospective chart review of patients ages 6 to 21 who present to the pediatric emergency department with sickle cell VOC listed as one of their diagnoses with the aim of identifying pain scores in accordance with medications received and identifying final disposition and identifying time in the emergency department and time to ED disposition. We aimed to review 100 charts. We found that 84 met inclusion criteria.

Trial Arm

Experimental group

Description:

The trial arm will be a prospective, convenience sampling of up to 100 patients ages 6 to 21 years who present to the pediatric emergency department with VOC listed as either their main complaint or as one of multiple complaints as identified by health care provider at time of presentation and meet inclusion criteria. The intervention will be virtual reality headset which will be offered simultaneously with standard medication therapy. We actually enrolled 17 patients who met inclusion criteria.

Treatment:

Other: Virtual Reality Goggles