Reality PAWS Program for Isolation

Not yet recruiting at 1 trial location
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital Colorado
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new virtual reality program called Reality PAWS to determine if it can reduce pain, anxiety, and loneliness in children in hospital isolation. Participants will use a VR headset to interact with the program and provide feedback through surveys. The study seeks children aged 8 to 21 who are staying at specific hospitals and do not have certain medical issues, such as motion sickness or seizure disorders. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative research that could enhance the hospital experience for many children.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a VR program, so it's unlikely that your medications would be affected, but you should check with the trial coordinators to be sure.

What prior data suggests that the Reality PAWS program is safe for pediatric patients in isolation?

Research has shown that virtual reality (VR) programs can be safe and beneficial for mental health. Studies have found that VR can reduce loneliness and enhance feelings of connection, particularly among older adults and teenagers. These studies suggest that VR is generally well-tolerated, with few reports of negative effects.

Specific safety data for the Reality PAWS program is not yet available, but this trial stage typically indicates low expected risks. The program uses a Meta Quest 3 VR headset, a device widely used safely for entertainment and other activities.

Overall, based on similar VR programs, the Reality PAWS program is likely safe for children. However, participants should inform the study team of any discomfort or issues during the trial.12345

Why are researchers excited about this trial?

The Reality PAWS Program is unique because it leverages virtual reality (VR) to help combat isolation. Unlike traditional approaches, such as medication or therapy sessions that require in-person attendance, this program uses the Meta Quest 3 VR device to create an immersive experience for participants. This innovative delivery method allows users to engage with their environment in a new way, potentially enhancing emotional well-being without the need for physical presence. Researchers are excited about this because it offers a novel way to address feelings of loneliness, making it accessible and engaging for individuals who might have limited mobility or social interaction opportunities.

What evidence suggests that the Reality PAWS program is effective for reducing pain, anxiety, and loneliness in pediatric patients in isolation?

Studies have shown that virtual reality programs can reduce loneliness and enhance social connection. Research suggests these programs are particularly beneficial for individuals who feel isolated, such as older adults or hospital patients. In this trial, participants will engage with the Reality PAWS VR Program, which aims to offer similar benefits for children in isolation by allowing interaction with virtual pets. Previous virtual reality programs have been linked to improved mental health and reduced loneliness. Although specific data on Reality PAWS is limited, its design draws on these encouraging findings.24678

Are You a Good Fit for This Trial?

This trial is for pediatric patients who are in isolation during hospital stays. It's designed to see if a virtual reality program called Reality PAWS can help with feelings of pain, anxiety, and loneliness as an alternative to in-person dog therapy.

Inclusion Criteria

I (or my child) can speak English.
My child is developing normally.
I am between 8 and 21 years old and admitted to Children's Hospital Colorado or Los Angeles.

Exclusion Criteria

Children with cochlear implants or pacemakers
I do not have brain injuries or disorders that could affect the study.
My child does not have sensory issues that would affect their participation.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants wear a Meta Quest 3 VR headset with the Reality PAWS program and interact with it for up to 30 minutes per session.

30 minutes per session
1 session (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including surveys on anxiety, pain, loneliness, and other measures.

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Reality PAWS Program
Trial Overview The study tests the Reality PAWS mixed reality program on Meta Quest 3 VR headsets. It checks how well children follow the program and measures its impact on their wellbeing through surveys about their emotions and experiences.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Reality PAWS VR Program Session on Meta Quest 3 VR DeviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Colorado

Lead Sponsor

Trials
121
Recruited
5,135,000+

Children's Hospital Los Angeles

Collaborator

Trials
257
Recruited
5,075,000+

Citations

Feasibility of the Reality PAWS Program for Children in ...What are the interventional outcomes of Reality PAWS MR? Participants will: Wear a Meta Quest 3 VR headset with the Reality PAWS program.
Reality PAWS Program for Isolation · Info for ParticipantsThis trial is for pediatric patients who are in isolation during hospital stays. It's designed to see if a virtual reality program called Reality PAWS can help ...
Virtual reality interventions to reduce social isolation in ...Addresses a timely evidence gap on the effectiveness of virtual reality interventions for social isolation and loneliness in a rapidly ageing ...
Using Virtual Reality to Address Loneliness and Increase ...A study shows virtual reality reduces loneliness and boosts social connectedness among older adults, offering a promising tool for mental ...
(PDF) Virtual reality interventions to reduce social isolation ...Secondary outcomes will include depression, quality of life, cognitive function, physical function and adverse events. Two reviewers will ...
NCT07187245 | Feasibility of the Reality PAWS Program ...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 ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38055309/
Improving Social Isolation and Loneliness Among ...The study findings demonstrated that a brief VR group program could be valuable for potentially improving mental health among adolescents with physical ...
A Systematic Scoping Review of Human-Dog Interactions ...This systematic scoping review searched ten databases to assess the current use and specifications of dog models which directly focused on human-dog ...
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