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NCT Number: NCT06922032

A Novel Auditory Application for Distraction in Pediatric Patients

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).

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Key information

Conditions

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location contact

Thomas J Caruso, MD, MEd

CONTACT

[email protected]

650-723-5728

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mystics Pet

Device

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 outcomes

  1. Feasibility of Mystics Pets, based on an unpublished focus group interview guide at the Department of Anesthesiology, Stanford University

    Time frame: immediately after intervention

    Participants will provide qualitative feedback on the acceptability and feasibility of the use of Mystics Pets. Example question will include: "Can you please tell me about your experience?"

Secondary outcomes

  1. ISO Ergonomic scale

    Time frame: immediately after intervention

    The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

  2. System Usability Scale (SUS) Score

    Time frame: immediately after intervention

    The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

  3. Game Engagement score

    Time frame: immediately after intervention

    Game Engagement score measured by Game Engagement Questionnaire. The scale has 16 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)

  4. Evaluate awe levels measured by Awe Experience Scale - Short Form

    Time frame: immediately after intervention

    The scale has 12 items. Scores ranges from 1-7 (1 = strongly disagree and 7 = strongly agree)

Study contacts

Contact information is provided by the study sponsor or research team.

Man Yee Suen, MMedSc

CONTACT

[email protected]

6504970927

Thomas Caruso, MD, PhD

CONTACT

[email protected]

6504970927

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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