Virtual Reality for Sickle Cell Disease
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Disqualifiers: Acute chest syndrome, Splenic sequestration, Post-operative pain, Cerebrovascular accident, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on adding virtual reality to standard therapy, so you may be able to continue your current treatment.
What data supports the effectiveness of the treatment KindVR Aqua Program for sickle cell disease?
Research suggests that virtual reality (VR) can help reduce pain and anxiety in various conditions, including sickle cell disease and type 1 diabetes. A study on hospitalized sickle cell patients found that a single VR session could improve their pain experience during painful episodes.
12345Is virtual reality safe for use in humans, particularly in pediatric settings?
A study reviewing the use of virtual reality in pediatric hospitals found it to be safe, with no significant adverse events reported when used under supervision.
12678How does virtual reality treatment differ from other treatments for sickle cell disease?
Virtual reality (VR) is unique for sickle cell disease as it offers a non-drug approach to help manage pain during vaso-occlusive episodes, which are painful blockages in blood vessels. Unlike traditional pain medications, VR provides an immersive experience that can distract patients from pain, potentially improving their overall pain experience without the side effects of drugs.
1391011Eligibility Criteria
This trial is for children with sickle cell disease experiencing vaso-occlusive pain crises. Participants must be hospitalized for the pain crisis and able to complete surveys. Specific inclusion or exclusion criteria are not provided, but typically these would detail age range, severity of condition, and any other health requirements or restrictions.Inclusion Criteria
No known cognitive or neurological deficits
I am between 8 and 21 years old.
I am admitted for severe pain management due to a sickle cell crisis.
+1 more
Exclusion Criteria
Patient has previously participated in the study
My sickle cell disease needs more than usual pain treatment.
The study team cannot start the study treatment within 24 hours of my admission.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (in-person)
Treatment
Participants receive standard therapy with or without daily virtual reality experience for up to 3 days
3 days
Daily in-hospital visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
Not applicable
Participant Groups
The study tests if virtual reality can reduce pain and opiate use in children with sickle cell disease during hospital stays for vaso-occlusive crises. It compares standard therapy alone to standard therapy plus a daily virtual reality program called KindVR Aqua Program.
2Treatment groups
Experimental Treatment
Active Control
Group I: CasesExperimental Treatment1 Intervention
In addition to receiving the standard of care for their vaso-occlusive pain, the case patients will have the opportunity to participate in the immersive VR experience after completing their initial pain assessment simulator sickness survey. Following the intervention, their pain levels will be reassessed at the 1-hour and 4-hour mark from their baseline assessment. Additionally, they will be asked to fill out an additional simulator sickness survey upon completion of the VR experience. This same timeline will occur on days 2 and 3 of admission. Prior to discharge or discontinuation from the study, the case patients will be asked to fill out the post-study questionnaire.
Group II: ControlsActive Control1 Intervention
Control patients will continue to receive the standard of care for their vaso-occlusive pain (IV fluid hydration, scheduled IV NSAID, and opiate medication) and have repeat pain assessments at 1 hour and 4 hours from their baseline assessment. This same timeline will occur on days 2 and 3 of admission
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of New OrleansNew Orleans, LA
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Who Is Running the Clinical Trial?
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
KindVRCollaborator
References
Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. [2019]Due to incomplete management of vaso-occlusive pain episodes (VOE) in patients with sickle cell disease (SCD), we sought to determine if immersive VR would be feasible for inpatients. Secondarily, we hypothesized that a single VR session would improve the VOE pain experience.
Changes in coping, pain, and activity after cognitive-behavioral training: a randomized clinical trial for pediatric sickle cell disease using smartphones. [2022]We examined the outcomes of a cognitive-behavioral therapy (CBT) intervention for pain in pediatric sickle cell disease (SCD) using smartphones as a novel delivery method.
Virtual reality's impact on children with type 1 diabetes: a proof-of-concept randomized cross-over trial on anxiety, pain, adherence, and glycemic control. [2023]Assess the effectiveness of virtual reality (VR) technology, in reducing pain and anxiety, and improving adherence and glycemic control among children with type 1 diabetes (T1D).
Use of consumer wearables to monitor and predict pain in patients with sickle cell disease. [2023]In sickle cell disease (SCD), unpredictable episodes of acute severe pain, known as vaso-occlusive crises (VOC), disrupt school, work activities and family life and ultimately lead to multiple hospitalizations. The ability to predict VOCs would allow a timely and adequate intervention. The first step towards this ultimate goal is to use patient-friendly and accessible technology to collect relevant data that helps infer a patient's pain experience during VOC. This study aims to: (1) determine the feasibility of remotely monitoring with a consumer wearable during hospitalization for VOC and up to 30 days after discharge, and (2) evaluate the accuracy of pain prediction using machine learning models based on physiological parameters measured by a consumer wearable.
Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. [2021]Clinical trials in sickle cell disease (SCD) often focus on health care utilization for painful vaso-occlusive crises (VOCs). However, no objective, quantifiable pain biomarkers exist, pain is not specific to VOCs, health care utilization varies between patients, unreported at-home VOCs likely contribute to long-term outcomes, and patient-reported outcomes are seldom considered. This noninterventional, longitudinal, 6-month study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization. Participants wore an actigraph device, tracking sleep and activity. Patients with SCD used an electronic patient-reported outcome (ePRO) tool to collect data on pain, medication, fatigue, and daily function. Patients self-reported when they experienced VOC pain (VOC day). Biomarkers were collected every 3 weeks (non-VOC). Self-reported VOCs triggered at-home or in-hospital blood collection. The study enrolled 37 participants with SCD; 35 completed the study. Participants reported 114 VOC events and 346 VOC days, of which 62.3% and 78.3%, respectively, were self-treated at home. The ePRO and actigraphy captured end points of pain, functionality, fatigue, activity, and sleep; each was significantly altered on VOC days compared with non-VOC days. Biomarkers collected at home or in the hospital on VOC days were significantly altered compared with non-VOC baseline values, including leukocyte-platelet aggregates, microfluidic-based blood cell adhesion, interleukin-6, C-reactive protein, interleukin-10, tumor necrosis factor-α, and thrombin-antithrombin. The Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) trial shows the feasibility of accurately monitoring out-of-hospital pain by using patient-reported VOC days as potential end points for clinical trials in SCD; it describes the changes in biomarkers and activity measured by actigraphy that may enable improved identification and assessment of VOCs.
An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision-making for Hydroxyurea in Sickle Cell Anemia. [2023]Although hydroxyurea (HU) is an effective treatment for sickle cell anemia, uptake remains low. Shared decision-making (SDM) is a recommended strategy for HU initiation to elicit family preferences; however, clinicians lack SDM training. We implemented an immersive virtual reality (VR) curriculum at 8 pediatric institutions to train clinicians on SDM that included counseling virtual patients. Clinicians' self-reported confidence significantly improved following the VR simulations on all communication skills assessed, including asking open-ended questions, eliciting specific concerns, and confirming understanding (Ps≤0.01 for all). VR may be an effective method for educating clinicians to engage in SDM for HU.
Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. [2022]Virtual reality (VR) is an emerging tool for anxiety and fear reduction in pediatric patients. VR use is facilitated by Certified Child Life Specialists (CCLS) at pediatric hospitals. The primary aim of this study was to retrospectively review the safety of VR by analyzing adverse events after the utilization of VR under CCLS supervision. Secondary objectives were to characterize the efficacy of VR in enhancing patient cooperation, describe the integration of VR into Child Life services, and identify interventions that accompanied VR.
A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. [2023]Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in lay language for individuals or families with SCD has not been evaluated. We conducted a feasibility randomized controlled trial to determine the acceptability of a mobile health (mHealth) app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and reduce hospitalizations. Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled at 2 sickle cell centers between 2018 and 2022. Participants were randomized to receive either an mHealth app + booklet with patient-facing guidelines or a booklet with the guidelines alone. Participants completed surveys at baseline and a final 6-month visit. Approximately 67 of 74 (91%) agreed to participate and were randomized, with 50 of 67 (75%) completing all the study components. All participants who completed the study in the treatment arm used the app. Our results demonstrated high recruitment, retention, and adherence rate for the first randomized trial for an mHealth app with patient-facing guidelines in adults with SCD. This clinical trial was registered at https://www.clinicaltrials.gov/ as #NCT03629678.
Feasibility and tolerability of ophthalmic virtual reality as a medical communication tool in children and young people. [2022]Virtual reality (VR) can be useful in explaining diseases and complications that affect children in order to improve medical communications with this vulnerable patient group. So far, children and young people's responses to high-end medical VR environments have never been assessed.
Virtual reality as a therapeutic modality for children with cerebral palsy. [2022]The evidence for using virtual reality (VR) with children with cerebral palsy (CP) was examined.
Low-cost virtual reality intervention program for children with developmental coordination disorder: a pilot feasibility study. [2015]To explore the feasibility of using a low-cost, off-the-shelf virtual reality (VR) game to treat young children with developmental coordination disorder (DCD) and to determine the effect of this intervention on motor function.