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Completed

NCT Number: NCT05864092

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

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).

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Key information

Conditions

Sickle Cell Crisis Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Vaso-Occlusive Crises

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 6 to 21 years
  • Sickle cell disease, any genotype
  • Diagnosis of VOC
  • Pain score of 4 or greater

Exclusion criteria

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

Treatment and study plan

Virtual reality goggles

Other

We will offer patients virtual reality goggles with guided meditation software in addition to standard medical therapy (NSAID and opioid).

Primary outcomes

  1. Pain Scores

    Time frame: 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.

    Patient pain scores will be recorded from time of patient presentation, after each dose of pain medication, at time of patient disposition. For the trial arm, pain scores will also be documented before and after the application of virtual reality goggles with guided meditation. Pain scores will be measured with the Wong-Baker Faces Scale generally for children 10 and under or depending on developmental and cognitive ability of the child or on a numeric scale from 0 to 10 with 0 correlating to "no pain" and 10 correlating to "severe pain."

  2. Patient Disposition

    Time frame: 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.

    Patient disposition (admitted to hospital or discharged from emergency department) will be recorded.

Secondary outcomes

  1. Length of Stay in the Emergency Department

    Time frame: 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.

    Time from patient arrival in the emergency department to patient leaving the emergency department (either through hospital admission or discharge)

  2. Time to Emergency Department Disposition

    Time frame: 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.

    Time from patient arrival in the emergency department to disposition decision (hospital admission or discharge)

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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