Feasibility of the Reality PAWS Program for Children in Isolation

NCT07187245 | Recruiting FDA Device

• 1 other identifier: 25-1732
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Inpatient Pediatric Care; Isolation; Feasibility Studies

Outcome Measures

Primary Outcomes (9)

• Recruitment Feasibility

  Number of screened patients, number of eligible patients, number of enrolled patients, number of withdrawn patients, number of subsequent Reality Paws sessions received/requested by patients.

  Through study completion, an average of 6 months.

• Intervention Feasibility - Time Spent Using MR

  Time spent using MR.

  From baseline until study session completion, approximately 30 minutes.

• Intervention Feasibility - Software

  Number of technology or software issues.

  From baseline until study session completion, approximately 30 minutes.

• Electonic Case Report Qualitative Feedback and Observations

  Qualitative self-reported and observed experience on the electronic case report form related to patient's engagement in the MR.

  From baseline until study session completion, approximately 30 minutes.

• Measurement Feasibility

  Percent of participants who completed all surveys. This will be determined by taking the number of survey's completed and dividing it by the total number of survey's.

  Through study completion, an average of six months.

• Child Simulator Sickness Questionnaire

  Assesses potential side effects of using Reality PAWS, children will provide ratings of simulator sickness using the 7-item Child Simulator Sickness Questionnaire. Consists of items related to potential side effects common to individuals after playing in virtual environments, such as "sickness, headache, and dizziness. The questionnaire asks about symptoms currently experienced as rated on a 0 - 2 scale, with 0 = No, 1 = A little, and 3 = A lot. There are three scoring categories: nausea, oculomotor, and disorientation, with specific questions falling under each category. Each category adds scores of three questions, and a score of three or more indicates simulator sickness.

  Completed at baseline and again at study session completion, approximately 30 minutes after completing the study intervention MR.

• Borg Rating of Perceived Exertion

  Children will rate their physical exertion after playing Reality PAWS using the Borg Rating of Perceived Exertion. This one-item scale consists of a single question asking children to rate their subjective feeling of exertion, without considering the kinds of physical demands that might lead to this feeling. The scale ranges from 6 (no exertion at all) to 20 (maximal exertion), with higher scores indicating higher levels of perceived exertion.

  At intervention session completion, approximately 30 minutes after starting the MR intervention.

• Gold-Rizzo Immersion and Presence

  The Gold-Rizzo Immersion and Presence assesses three domains: sense of involvement, perceived realism, and sense of transportation within the software. The measure contains 16 questions where patients can respond either "no," "a little," or "a lot." Higher total scores indicate a higher level of immersion.

  Completed at study session completion, approximately 30 minutes after completing the MR intervention.

• Amount of adverse or serious adverse events

  Number of adverse and/or serious adverse events.

  Until study completion, about 6 months.

Secondary Outcomes (5)

• Faces Anxiety Scale

  Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.

• Faces Pain Scale

  Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.

• Childhood Anxiety Sensitivity Index

  Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.

• Loneliness Visual Analog Scale

  Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.

• Multidimensional State Boredom Scale - Short Form

  Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.

Study Arms (1)

Reality PAWS VR Program Session on Meta Quest 3 VR Device

EXPERIMENTAL

Participants will be able to wear a Meta Quest 3 VR Device and interact with the Reality PAWS VR program for up to 30 minutes per session.

Device: Reality PAWS Program via Meta Quest 3 VR

Interventions

Reality PAWS Program via Meta Quest 3 VR DEVICE

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.

Reality PAWS VR Program Session on Meta Quest 3 VR Device

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Colorado: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

NOT YET RECRUITING

Children's Hospital Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)