Inpatient Pediatric CareNCT07187245
Feasibility of the Reality PAWS Program for Children in Isolation
A study testing Reality PAWS Program via Meta Quest 3 VR in people with Inpatient Pediatric Care and Isolation, run by Children's Hospital Colorado at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Inpatient Pediatric Care, Isolation, Feasibility Studies
- What is being tested?
- Reality PAWS Program via Meta Quest 3 VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Claire Simonsen, BA, 720-777-5313, claire.simonsen@childrenscolorado.org
Jennifer H Staab, MS, CCLS
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Saloni Dangoria, (323) 361-4342 ext. 14342, sdangoria@chla.usc.edu
Jeffrey Gold, PhD
About this study
Official title: Reality PAWS: Examining the Feasibility of a Mixed Reality Dog Visitation Program for Hospitalized Children in Isolation
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?
Read more
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
- Being tested
- Reality PAWS Program via Meta Quest 3 VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reality PAWS Program via Meta Quest 3 VRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Reality PAWS Program via Meta Quest 3 VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 6 months.
Intervention Feasibility - Time Spent Using MR
Time spent using MR.
Measured: From baseline until study session completion, approximately 30 minutes.
Intervention Feasibility - Software
Number of technology or software issues.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Until study completion, about 6 months.
Secondary outcomes (5)
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.
Measured: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.
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."
Measured: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.
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.
Measured: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.
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.
Measured: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.
Multidimensional State Boredom Scale - Short Form
An eight question scale that is used for brief assessments of boredom. Participants are asked to rank their agreement with the statements using a 7-point Likert scale, 1= Strongly disagree, and 7= Strongly agree, with higher scores indicate higher levels of state boredom.
Measured: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start29 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inpatient Pediatric CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Colorado
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Jennifer Staab, MS, CCLS, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187245
- Sponsor's protocol ID
- 25-1732
- Status last verified
- Apr 2026
- First submitted
- 10 Sep 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reality PAWS: Examining the Feasibility of a Mixed Reality Dog Visitation Program for Hospitalized Children in Isolation
- ClinicalTrials.gov ID
- NCT07187245
- Acronym / sponsor ID
- 25-1732
- Conditions
- Inpatient Pediatric Care, Isolation, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital ColoradoUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reality PAWS VR Program Session on Meta Quest 3 VR Device | Experimental | Device: Reality PAWS Program via Meta Quest 3 VRParticipants 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reality PAWS Program via Meta Quest 3 VRReality 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. | Device | Reality PAWS VR Program Session on Meta Quest 3 VR Device |
Primary outcome
Recruitment Feasibility
Time frame: Through study completion, an average of 6 months.
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.
Intervention Feasibility - Time Spent Using MR
Time frame: From baseline until study session completion, approximately 30 minutes.
Time spent using MR.
Intervention Feasibility - Software
Time frame: From baseline until study session completion, approximately 30 minutes.
Number of technology or software issues.
Electonic Case Report Qualitative Feedback and Observations
Time frame: From baseline until study session completion, approximately 30 minutes.
Qualitative self-reported and observed experience on the electronic case report form related to patient's engagement in the MR.
Measurement Feasibility
Time frame: Through study completion, an average of six months.
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.
Child Simulator Sickness Questionnaire
Time frame: Completed at baseline and again at study session completion, approximately 30 minutes after completing the study intervention MR.
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.
Borg Rating of Perceived Exertion
Time frame: At intervention session completion, approximately 30 minutes after starting the MR intervention.
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.
Gold-Rizzo Immersion and Presence
Time frame: Completed at study session completion, approximately 30 minutes after completing the MR intervention.
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.
Amount of adverse or serious adverse events
Time frame: Until study completion, about 6 months.
Number of adverse and/or serious adverse events.
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Children's Hospital Los Angeles
Los Angeles, United States
Children's Hospital Colorado Anschutz Medical Campus
Aurora, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reality PAWS Program via Meta Quest 3 VR in people with Inpatient Pediatric Care and Isolation, run by Children's Hospital Colorado at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Through study completion, an average of 6 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.