A Novel Auditory Application for Distraction in Pediatric Patients

Not Applicable

Recruiting

• Conditions: Emotional Distress

• Registration Number: NCT06922032
• Lead Sponsor: Stanford University

Brief Summary

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.

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Study Start: 2025-07-01
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Mystics Pets, based on an unpublished focus group interview guide at the Department of Anesthesiology, Stanford University	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 Outcome Measures

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

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States