RecruitingNot Applicable

Feasibility of the Reality PAWS Program for Children in Isolation

United States50 participantsStarted 2026-01-29

Plain-language 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.

Who can participate

Age range8 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Recruitment Feasibility

Timeframe: Through study completion, an average of 6 months.

Intervention Feasibility - Time Spent Using MR

Timeframe: From baseline until study session completion, approximately 30 minutes.

Intervention Feasibility - Software

Timeframe: From baseline until study session completion, approximately 30 minutes.

Electonic Case Report Qualitative Feedback and Observations

Timeframe: From baseline until study session completion, approximately 30 minutes.

Measurement Feasibility

Timeframe: Through study completion, an average of six months.

Child Simulator Sickness Questionnaire

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

Borg Rating of Perceived Exertion

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

Trial details

NCT IDNCT07187245

SponsorChildren's Hospital Colorado

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

View on ClinicalTrials.gov More Inpatient Pediatric Care trials

Plain-language summary

Who can participate

Age range8 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recruitment Feasibility

Timeframe: Through study completion, an average of 6 months.

Intervention Feasibility - Time Spent Using MR

Timeframe: From baseline until study session completion, approximately 30 minutes.

Intervention Feasibility - Software

Timeframe: From baseline until study session completion, approximately 30 minutes.

Electonic Case Report Qualitative Feedback and Observations

Timeframe: From baseline until study session completion, approximately 30 minutes.

Measurement Feasibility

Timeframe: Through study completion, an average of six months.

Child Simulator Sickness Questionnaire

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

Borg Rating of Perceived Exertion

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