Menu
Recruiting NCT07187245

Feasibility of the Reality PAWS Program for Children in Isolation

No phase Interventional Inpatient Pediatric Care Isolation Feasibility Studies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reality PAWS Program via Meta Quest 3 VR.
Who it may be relevant to
Registry conditions: Inpatient Pediatric Care, Isolation, Feasibility Studies. Basic parameters: 8 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Reality PAWS: Examining the Feasibility of a Mixed Reality Dog Visitation Program for Hospitalized Children in Isolation

Overview

The goal of this clinical trial is to learn if a mixed reality program, Reality PAWS, delivered on a Meta Quest 3 VR headset, is a feasible intervention for pediatric patients in isolation. It will also evaluate the safety of the program and its effect on pain, anxiety, and loneliness. The main questions the study aims to answer are: What is the feasibility of utilizing Reality PAWS MR as a substitute for in-person dog therapy for children under isolation precautions? Are patients compliant with using Reality PAWS MR? What are the interventional outcomes of Reality PAWS MR? Participants will: Wear a Meta Quest 3 VR headset with the Reality PAWS program. Interact with the program. Answer surveys regarding demographics, anxiety, pain, loneliness, sickness, perceived exertion, and immersion in the program.

Interventions

  • Device Reality PAWS Program via Meta Quest 3 VR
    Reality PAWS is a mixed reality (MR) game that allows patients to interact with a virtual dog. It was developed at Children's Hospital Colorado to serve patients under isolation precautions who are unable to be visited by a facility dog in person. Patients can interact with the game through features such as walking the dog, providing commands, outfitting the dog, giving treats, playing fetch, petting the dog, and playing with others.

Primary outcome measures

  • Recruitment Feasibility [Time frame: Through study completion, an average of 6 months.]
  • Intervention Feasibility - Time Spent Using MR [Time frame: From baseline until study session completion, approximately 30 minutes.]
  • Intervention Feasibility - Software [Time frame: From baseline until study session completion, approximately 30 minutes.]
  • Electonic Case Report Qualitative Feedback and Observations [Time frame: From baseline until study session completion, approximately 30 minutes.]
  • Measurement Feasibility [Time frame: Through study completion, an average of six months.]
  • Child Simulator Sickness Questionnaire [Time frame: Completed at baseline and again at study session completion, approximately 30 minutes after completing the study intervention MR.]
  • Borg Rating of Perceived Exertion [Time frame: At intervention session completion, approximately 30 minutes after starting the MR intervention.]
  • Gold-Rizzo Immersion and Presence [Time frame: Completed at study session completion, approximately 30 minutes after completing the MR intervention.]
  • Amount of adverse or serious adverse events [Time frame: Until study completion, about 6 months.]
Secondary outcome measures (5)
  • Faces Anxiety Scale [Time frame: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Faces Pain Scale [Time frame: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Childhood Anxiety Sensitivity Index [Time frame: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Loneliness Visual Analog Scale [Time frame: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Multidimensional State Boredom Scale - Short Form [Time frame: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]

Eligibility criteria

Inclusion criteria

  • Children 8 to 21 years old admitted to Children's Hospital Colorado or Children's Hospital Los Angeles
  • Children who are English-speaking (legal guardian may be English-speaking or Spanish-speaking)
  • Children within the normal range of development will be recruited for this study.

Exclusion criteria

  • Traumatic brain injury, neurological disorders, neurodevelopmental issues, or other neurological disorders and comorbidities that may confound study outcomes and administration of the study protocol and metrics (e.g., visual field disturbances, frequent nausea/ vomiting, not medically stable, intellectual disability)
  • Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
  • Children with a history of seizure disorder
  • Children currently sick with flu-like symptoms or experiencing a headache or earache
  • Children with known or suspected motion sickness
  • Children with cochlear implants or pace makers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Children's Hospital Los Angeles — Los Angeles
  • Children's Hospital Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT07187245 · 25-1732

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗