Clinical trial NCT06922032: A Novel Auditory Application for Distraction in Pediatric Patients
Official title: A Novel Auditory Application for Distraction in Pediatric Patients: A Pilot Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Distress
Keywords: Game engagement
Awe
Procedural Distraction
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of Mystics Pets, based on an unpublished focus group interview guide at the Department of Anesthesiology, Stanford University
timeFrame: immediately after intervention
Secondary outcomes:
measure: ISO Ergonomic scale
timeFrame: immediately after intervention
measure: System Usability Scale (SUS) Score
timeFrame: immediately after intervention
measure: Game Engagement score
timeFrame: immediately after intervention
measure: Evaluate awe levels measured by Awe Experience Scale - Short Form
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References: