A Novel Auditory Application for Distraction in Pediatric Patients

NCT ID: NCT06922032

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Emotional Distress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mystics Pets group

Group Type: EXPERIMENTAL

Mystics Pet

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Caruso

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Countries

United States

Central Contacts

Thomas Caruso, MD, PhD

Role: CONTACT

tjcaruso@stanford.edu

6504970927

Man Yee Suen, MMedSc

Role: CONTACT

smy822@stanford.edu

6504970927

Facility Contacts

Thomas J Caruso, MD, MEd

Role: primary

tjcaruso@stanford.edu

650-723-5728

Other Identifiers

80354

Identifier Type: -

Identifier Source: org_study_id