Feasibility of the Reality PAWS Program for Children in Isolation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-21
SponsorChildren's Hospital Colorado
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Reality PAWS Program via Meta Quest 3 VR
DeviceReality 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Reality PAWS VR Program Session on Meta Quest 3 VR DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 6 months.2
Intervention Feasibility - Time Spent Using MR
Time spent using MR.
Time frame
From baseline until study session completion, approximately 30 minutes.3
Intervention Feasibility - Software
Number of technology or software issues.
Time frame
From baseline until study session completion, approximately 30 minutes.4
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.
Time frame
From baseline until study session completion, approximately 30 minutes.Secondary outcomes
1
Faces Anxiety Scale
Children will be asked to report their anxiety using the Faces Anxiety Scale before and after the MR session. The Faces Anxiety Scale is a single item scale with five possible responses ranging from a neutral face to one showing extreme fear.
Time frame
Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.2
Faces Pain Scale
The Faces Pain Scale - Revised (FPS-R) is a valid and reliable self-report measure where patients see a scale of 6 different faces representing various intensities of pain, ranging from "no pain" to "very much pain."
Time frame
Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.3
Childhood Anxiety Sensitivity Index
A modified version of the Anxiety Sensitivity Index, and is a self-report questionnaire which measures a child's belief that their anxiety will have negative consequences.
Time frame
Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.4
Loneliness Visual Analog Scale
Used to assess loneliness in children via a one-item, self-report, visual analog scale thermometer that includes faces as anchors. The question asks how lonely the child is feeling in the moment, on a rating scale from 0 being not lonely at all, and 10 being extremely lonely.
Time frame
Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Colorado
Lead sponsor
Children's Hospital Los Angeles
Collaborator
Source ClinicalTrials.gov