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

Sponsor
University of Mississippi Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05864092
Collaborator
(none)
200
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality Goggles
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
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.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.
Masking:
None (Open Label)
Masking Description:
Masking and randomization is not possible due to the nature of the virtual reality goggles.
Primary Purpose:
Treatment
Official Title:
Virtual Reality as an Adjuvant Therapy for Sickle Cell Vaso-Occlusive Crisis in the Pediatric Emergency Department
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Arm

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 aim to review 100 charts.
Experimental: Trial Arm

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.

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

Outcome Measures

Primary Outcome Measures

  1. Pain Scores [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 minutes.]

    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.

  2. Patient Disposition [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 Outcome Measures

  1. Length of Stay in the Emergency Department [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 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Mississippi Medical Center

Investigators

  • Principal Investigator: Matthew Maready, MD, University of Mississippi Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT05864092
Other Study ID Numbers:
  • UMMC-IRB-2023-8
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Mississippi Medical Center
Virtual Reality
Sickle Cell Crisis
Additional relevant MeSH terms:
Emergencies

Study Results

No Results Posted as of May 18, 2023