- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07637617
Large Language Model-Driven Personalization of Virtual Reality Interventions to Improve Pediatric Inpatient Experience and Reduce Needle Anxiety (LLM-audiobook)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samuel Rodriguez, MD
- Phone Number: 650-723-5728
- Email: sr1@stanford.edu
Study Contact Backup
- Name: ManYee Suen, MMedSc
- Phone Number: 650-723-5728
- Email: smy822@stanford.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English-speaking patients admitted for ≥24 hours
Exclusion Criteria:
- Acute medical instability
- Contact or airborne isolation precautions (precluding shared device use)
- Vision or hearing impairment
- Severe cognitive or developmental impairment
- Active seizure disorder
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pediatric patient
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine the acceptability of the Large Language Model generated audiobook
Time Frame: Immediately after intervention
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Samuel Rodriguez, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 87422
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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