Sickle Cell Disease, Vaso-occlusive Pain Episodes
Conditions
Keywords
virtual reality, adjunctive therapy, opiate consumption, pain reduction
Brief summary
The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are: Does virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis? Does virtual reality decrease the daily use of opiates? Researchers will compare standard therapy to the use of standard therapy plus a daily virtual reality experience to see if virtual reality works to treat sickle cell pain. All patients will: \- Be asked to fill out a pain assessment survey three times daily for up to 3 days If randomized to intervention arm, patients will: * Participate in an immersive virtual reality experience once daily for up to 3 days * Fill out a survey twice daily to monitor for side effects from virtual reality experience * Fill out a satisfaction survey once during the study period
Detailed description
A vaso-occlusive pain crisis is the most common complaint for which a patient with sickle cell disease requires admission to the hospital. These pain episodes can often be complex and difficult to manage as medical providers know each individual patient perceives pain differently. In this regard, it has been well studied that a multi-disciplinary approach is required to address the biological, psychological, and social factors that comprise a patient's experienced pain. The current standard therapy for vaso-occlusive pain is heavily reliant on opioid therapy, which is why efforts have been made to find other complementary therapies with intentions of reducing this need. By conducting this study, the investigators hope to show that virtual reality can not only provide a complementary role in addressing sickle cell pain but also enhance patient satisfaction for those who have been admitted to the inpatient unit in a time of need. The idea of using virtual reality as a complementary therapy to address pain and stress in different types of medical patients has been introduced and explored for the last 10 years. There are a limited number of studies currently being carried out, but since 2014, the KindVR company has partnered with medical institutions across the United States and Canada to study the impacts that virtual reality can have on different pediatric patients. This includes sickle cell patients experiencing a pain crisis, cancer patients undergoing port access, burn patients, and those dealing with stress associated with a procedure or imaging study. A previous study in 2018 displayed the feasibility of administering a virtual reality (VR) experience to patients admitted to the hospital for a sickle cell pain crisis. However, there are no published studies assessing the measurable impacts that the use of VR could have on aspects of patient care. It is well known that a multi-disciplinary approach is the best method to address sickle cell pain. The investigators believe it would be interesting to see if the advanced technology of virtual reality can provide a complementary role to the current standard of care. To best elicit the results of our treatment intervention, this study will be constructed as a randomized control study. During the screening phase, every patient that is admitted to Children's Hospital of New Orleans for a vaso-occlusive pain episode will first have eligibility for enrollment into the study determined by established inclusion and exclusion criteria. Prior to enrollment, informed consent, patient assent (if applicable), and Health Insurance Portability and Accountability Act (HIPAA) authorization will be obtained. For the study treatment phase, patients will be assigned to either the control or case group. Control patients will undergo scheduled pain assessments while receiving standard of care therapy for a vaso-occlusive pain crisis. Case patients will undergo scheduled pain assessments while receiving standard of care therapy in addition to participating in a daily immersive VR experience during admission for a vaso-occlusive pain crisis. Both groups of patients will concurrently be in the hospital at the same time. All patients will participate in the study for a maximum of 3 days while enrolled on study and remain admitted requiring further treatment for vaso-occlusive pain. There will be no follow-up phase as a part of this study.
Interventions
DEVICEKindVR Aqua Program
For this study, patients will be introduced to a virtual reality software program called Aqua, created by the company KindVR. This software program was designed specifically for use in pediatric patients. The software has been programmed into the Pico Neo 3 headset and provides an immersive 3D experience during which the patients explore a virtual underwater world inside a submarine with a goal of providing more color to treasure and different sea animals that they will engage with along their journey. The VR experience itself lasts approximately 15 minutes
Sponsors
KindVR
Louisiana State University Health Sciences Center in New Orleans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized Controlled Study * Control patients will receive standard of care therapy for their vaso-occlusive pain crisis * Case patients will receive standard of care therapy PLUS VR experience for their vaso-occlusive pain crisis * Patients will be randomly assigned into the case or control group based off a random number system that will assign N/2 patients into each group. The statistician included on this project will generate the random numbers prior to the enrollment of the first patient onto the study. * To ensure equality between case and control groups, block stratification based on age and gender will be utilized at the time of data analysis
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Patient ≥ 8 up to 21 years of age 2. Presenting to CHNOLA ER or outside facility with chief complaint of vaso-occlusive pain crisis, requiring inpatient admission for further pain management 3. No known cognitive or neurological deficits 4. Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion criteria
1. Patients aged 7-years-old and younger. 2. Patents upon admission found to have sequela of their sickle cell disease that would require medical therapy greater than the standard of care for a vaso-occlusive pain event. This includes acute chest syndrome, splenic sequestration, post-operative pain, and/or cerebrovascular accident 3. Patients who are developmentally or cognitively incapable of using VR equipment and answering questions appropriately 4. Failure to obtain or refusal to provide parental/guardian permission (informed consent) and if appropriate child assent 5. Patient has previously participated in the study 6. Study team is unable to initiate study interventions within the first 24 hours of a patient's admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | From enrollment to the end of hospital admission day 3. | The Adolescent-Pediatric Pain Tool is a well validated, multidimensional pain assessment tool designed to evaluate the location, severity, and quality of pain in pediatric patients. It is comprised of three independent parts, one which is a 10 cm line anchored from 0 to10, with zero being equivalent to no pain and 10 being equivalent to worst pain possible. This data point will be collected up to 9 times for each participant in this study. The trends will be compared amongst the control and case groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opiate Consumption | From enrollment to the end of hospital admission day 3. | Goal is to assess virtual reality's ability to decrease a patient's total opiate consumption during their inpatient admission. Equivalent opiate dosing per day, measured in oral morphine equivalents/kg/day for each participant. |
| Hospital Length of Stay. | From enrollment to hospital discharge (an average of 5 days) | Assessing whether the use of virtual reality for a patient's vaso-occlusive pain crisis can reduce their length of stay in the hospital. Measured in number of days. |
| Patient Satisfaction (for case patients only) | Once, on day 2 or day 3 of enrollment | The study will evaluate whether the use of virtual reality's ability to improve patient satisfaction for their hospital admission. This will be measured via the use of the Post-Study Questionnaire, a 16-question survey provided by the KindVR company. It will be used to assess the patient's satisfaction of the Aqua program, the comfort of the equipment, and future guidance to aid quality improvement. |
Countries
United States
Contacts
Primary ContactMolly E Sonenklar, MD
Backup ContactCasey M Treuting, MD
Outcome results
None listed