Children’s Hospital Colorado and Children’s Hospital Los Angeles have initiated a groundbreaking clinical trial to assess the feasibility of using the Reality PAWS Program, delivered through Meta Quest 3 VR devices, for pediatric patients in isolation. This study, slated as “Not yet recruiting,” aims to tackle mental and emotional challenges faced by isolated inpatient children.
This clinical intervention seeks to measure the effectiveness and safety of integrating virtual reality platforms into pediatric inpatient care under strict isolation conditions. Designed by leading pediatric centers, it could redefine how care teams address emotional well-being within regulated environments.
What changed?
The Reality PAWS Program marks an innovative step in pediatric inpatient care, offering an immersive virtual reality-based intervention targeted at children undergoing isolative treatment. The announcement of this feasibility study signals a shift in how regulated environments may use technology to improve patient outcomes. Trials like these also set a precedent for regulated policies on virtual reality devices in clinical settings.
What is the study about?
Sponsored by Children’s Hospital Colorado and Children’s Hospital Los Angeles, this feasibility study will evaluate the Reality PAWS Program’s ability to support emotional relief and mental health stabilization for children confined to isolation during inpatient care.
Key Conditions
The study will focus on patients in isolation due to medical conditions requiring restricted environments. Acute hospitalization frequently leads to stress and exacerbation of isolation-related mental health issues, necessitating innovative solutions.
Intervention Overview
The intervention relies on Meta Quest 3 VR devices, which offer immersive experiences aimed at engaging and comforting young patients. The program’s goal is to provide distraction therapy and a sense of connection in cases where human interaction is heavily limited.
How does the Reality PAWS Program work?
The Reality PAWS Program leverages virtual reality content designed specifically for pediatric patients. Using the Meta Quest 3, children in isolation can engage with therapeutic environments customized to promote relaxation, mindfulness, and a sense of normalcy.
The devices are monitored by trained medical personnel to ensure safety and compliance with regulatory standards for medical devices. Data collected during the feasibility study will inform future enhancements, ensuring that both performance and safety meet stringent requirements.
Safety Considerations
As a clinical trial, the Reality PAWS Program follows strict safety protocols monitored under medical device regulations. Comprehensive pre-launch assessments will focus on usability for pediatric patients, ergonomic adaptation, and exposure limits to VR environments.
Objectives
The primary objective is to test efficacy under clinical conditions. Secondary objectives include exploring cost-effectiveness, scalability, and alignment with MDR (Medical Device Regulation) standards.
Frequently Asked Questions
- What age group will benefit from the study?
The study targets pediatric inpatients undergoing isolation treatments, but specific age ranges will be determined upon recruitment. - Why Meta Quest 3?
Meta Quest 3 was chosen for its immersive content capabilities and adaptability to clinical settings. - When does recruitment begin?
Recruitment is not yet open. Updates will follow once feasibility assessments are completed. - What type of data will be collected?
Data on engagement levels, emotional impact, and system performance will be analyzed.
Implications for Clinical Teams
The feasibility of virtual reality as a clinical intervention for children in isolation remains a highly anticipated breakthrough. Clinical teams must prepare for new protocols, broader integration of medical devices like Meta Quest 3, and an increased focus on patient-centric technology. Regulatory insights from this trial could influence approval paths globally.
Disclaimer for Medical Professionals
This document is informational only and does not constitute legal or clinical guidance. It is intended for use by medical and regulatory professionals familiar with related device processes and compliance standards.
Announcement Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07187245?term=medical+device