NCT07637617

Brief Summary

Hospitalization strips pediatric patients of the environments, objects, and people that shape their daily lives. Hospitalized pediatric patients routinely experience painful procedures, psychological distress, boredom, and a disorienting loss of personal identity. These experiences measurably worsen anxiety, reduce cooperation with care, and diminish the quality of the inpatient experience for both patients and families.1-7 Immersive digital interventions, including VR and tablet-based experiences, have emerged as a promising class of tools for addressing these challenges. Prior studies from The Stanford Chariot Program have demonstrated that digitally delivered, patient-centered experiences can meaningfully reduce procedural anxiety and improve engagement in hospitalized children.8-12 Yet, an important limitation persists in these technologies - current digital interventions largely remain in one-size-fits-all formats. Every child receives the same content, regardless of who they are, what they love, or what makes them feel at home in the world. This design limits therapeutic relevance, constrains engagement, and represents a missed opportunity to engage children, reduce anxiety, and enhance their quality of life during hospital stays.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

12 months

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

feasibilityacceptabilityusability

Outcome Measures

Primary Outcomes (1)

  • Determine the acceptability of the Large Language Model generated audiobook

    Semi-structured focus group interviews conducted in person immediately after intervention. Six core questions plus probing prompts assessing attitudes and opinions, and perceptions of the intervention experience

    Immediately after intervention

Study Arms (1)

Pediatric patient

EXPERIMENTAL
Behavioral: LLM-audiobook

Interventions

LLM-audiobookBEHAVIORAL

Develop and refine a two-stage personalization LLM pipeline: (1) a structured brief interview template and (2) an LLM prompt chain for content generation. The interview instrument will be a structured guide (\~20 minutes) capturing details about the child's background, interests, and aspirations. All information collected during the interview will be deidentified prior to being passed into the LLM. Content Generation: Deidentified interview responses will be input to a standardized LLM prompt pipeline. The pipeline generates a structured patient profile that interprets the participant's interests, personality, and preferences, then uses that profile to produce a personalized narrative, formatted as a picture book story. AI voice synthesis will generate an audio narration of the story. AI image generation tools will produce a set of 6-10 accompanying illustrations. The final product - a synchronized audio picture book - will be delivered via VR headset at bedside.

Pediatric patient

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • English-speaking patients admitted for ≥24 hours

You may not qualify if:

  • Acute medical instability
  • Contact or airborne isolation precautions (precluding shared device use)
  • Vision or hearing impairment
  • Severe cognitive or developmental impairment
  • Active seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Samuel Rodriguez, MD

    Stanford University

    STUDY DIRECTOR

Central Study Contacts

Samuel Rodriguez, MD

CONTACT

ManYee Suen, MMedSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share