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Not yet recruiting NCT06922032

A Novel Auditory Application for Distraction in Pediatric Patients

No phase Interventional Emotional Distress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mystics Pet.
Who it may be relevant to
Registry conditions: Emotional Distress. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Novel Auditory Application for Distraction in Pediatric Patients: A Pilot Feasibility and Acceptability Study

Overview

This mixed-methods study seeks to evaluate the feasibility of Mystic Pets software and hardware within the pediatric population. This study will take place at Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA).

Detailed description

Hospitalized children often experience emotional distress related to medical procedures, unfamiliar environments, and limited control over their situations. Existing distraction techniques, such as traditional videos and gaming, often rely heavily on visual interfaces, which can be limiting in clinical contexts. Current immersive technology software and hardware for procedural distraction rely on partial to complete immersion in a computer-generated environment to the real world. While immersive technology can reduce emotional distress with distraction, some patients experience increased distress due to loss of visual connection with their surroundings and/or caregivers. Using a head-mounted device and hand-gesture inputs, Mystic Pets maintains visual contact with a person's surroundings while gameplay is advanced through audio input and hand-gestures.

This research will significantly contribute to the growing field of digital therapeutics by providing early-stage data on a novel, immersive technology tailored to pediatric clinical care. If proven feasible, Mystic Pets could expand the toolkit available for procedural distraction, enhance patient comfort, and reduce the reliance on pharmacological interventions for emotion distress management.

The study also aims to establish preliminary engagement and usability benchmarks to guide future development and deployment of similar technologies in hospital environments.

Interventions

  • Device Mystics Pet
    Participants will receive the game intervention and be instructed to wear a Oculus Quest 2 headset (Meta, Inc., Menlo Park, CA) and participate in Mystic Pets software game (Stanford Chariot Program, Palo Alto, CA) that is specifically designed to promote overall distraction and emotional distress reduction.

Primary outcome measures

  • Feasibility of Mystics Pets, based on an unpublished focus group interview guide at the Department of Anesthesiology, Stanford University [Time frame: immediately after intervention]
Secondary outcome measures (4)
  • ISO Ergonomic scale [Time frame: immediately after intervention]
  • System Usability Scale (SUS) Score [Time frame: immediately after intervention]
  • Game Engagement score [Time frame: immediately after intervention]
  • Evaluate awe levels measured by Awe Experience Scale - Short Form [Time frame: immediately after intervention]

Eligibility criteria

Inclusion criteria

  • Between 4-17 years
  • English speaking participants

Exclusion criteria

  • Legal guardian not present to obtain consent
  • Child with hearing impairment
  • Child with a significant neurological condition, or major developmental disability
  • Child with facial abnormalities or injuries prohibiting use of headsets
  • Nausea at the time of recruitment,
  • A history of severe motion sickness,
  • A history of seizures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Lucile Packard Children's Hospital Stanford — Palo Alto

Identifiers

NCT: NCT06922032 · 80354

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗