A Novel Auditory Application for Distraction in Pediatric Patients

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Emotional Distress
• Intervention / Treatment: Device: Mystics Pet

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Caruso, MD, PhD; Phone Number: 6504970927; Email: tjcaruso@stanford.edu
• Study Contact Backup: Name: Man Yee Suen, MMedSc; Phone Number: 6504970927; Email: smy822@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
      • Contact: Thomas J Caruso, MD, MEd; Phone Number: 650-723-5728; Email: tjcaruso@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mystics Pets group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Mystics Pets, based on an unpublished focus group interview guide at the Department of Anesthesiology, Stanford University	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?"	immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISO Ergonomic scale	The scale has 6 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)	immediately after intervention
System Usability Scale (SUS) Score	The scale has 10 items. Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)	immediately after intervention
Game Engagement score	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)	immediately after intervention
Evaluate awe levels measured by Awe Experience Scale - Short Form	The scale has 12 items. Scores ranges from 1-7 (1 = strongly disagree and 7 = strongly agree)	immediately after intervention

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Awe; Game engagement; Procedural Distraction
• Other Study ID Numbers: 80354

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No