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Evaluating the Acceptability of AI-Personalized Virtual Reality Picture Books for Hospitalized Pediatric Patients (LLM-audiobook)

16. august 2026 oppdatert av: Thomas Caruso, Stanford University

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. 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.

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Samuel Rodriguez, MD
  • Telefonnummer: 650-723-5728
  • E-post: sr1@stanford.edu

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Between age 9-17
  • Current admission in inpatient unit
  • Able to understand and interact with a virtual reality audiobook in English

Exclusion Criteria:

  • Legal guardian not present to obtain consent
  • Significant cognitive impairment and/or developmental delay
  • History of seizures
  • History of severe motion sickness
  • Severe visual or motor impairment limiting picture book participation
  • Child with active infection of the face or hand
  • Acute medical instability
  • Inability to understand English

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Determine the acceptability of the Large Language Model generated audiobook
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To assess the degree to which participants identified with the protagonist of the personalized audio picture book.
Tidsramme: Immediately after intervention

Participants will complete the Cohen Identification Scale following the VR experience.

Items are answered using a 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree. Item responses will be averaged to generate a composite score, with higher scores indicating greater identification with the main character.

Immediately after intervention
To assess emotional state using Positive and Negative Affect Schedule - Child Form (PANAS-C)
Tidsramme: baseline, Immediately after intervention
The PANAS-C measures the degree to which children experience positive and negative affective states, yielding two subscale scores: Positive Affect and Negative Affect. Items are answered using a 5-point Likert scale ranging from 1 = very slightly or not at all to 5 = extremely. Higher Positive Affect (PA) Score indicates a higher level of positive emotions while higher Negative Affect (NA) Score indicates a higher level of negative emotions.
baseline, Immediately after intervention
To assess subjective wellbeing using the World Health Organization-Five Child Well-Being Index (WHO-5)
Tidsramme: baseline, Immediately after intervention
The WHO-5 is a brief, validated self-report measure assessing current mental wellbeing across five positively worded items covering mood, relaxation, energy, rest, and daily interest. The WHO-5 instructs respondents to rate how they have felt "over the last two weeks,"; the scale will be modified in this study to ask the participants to reflect on their current state. Items are answered using a 5-point Likert scale ranging from 0 = never to 5 = all of the time. To calculate the overall wellbeing score, the responses to the five items are summed and the total is multiplied by 5, yielding a final score between 0 and 100. Higher scores reflect higher levels of wellbeing.
baseline, Immediately after intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Samuel Rodriguez, MD, Stanford University
  • Hovedetterforsker: Thomas Caruso, MD,PhD, Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. august 2027

Studiet fullført (Antatt)

31. august 2027

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 87422

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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