- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07637617
Evaluating the Acceptability of AI-Personalized Virtual Reality Picture Books for Hospitalized Pediatric Patients (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. 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Samuel Rodriguez, MD
- Número de teléfono: 650-723-5728
- Correo electrónico: sr1@stanford.edu
Copia de seguridad de contactos de estudio
- Nombre: ManYee Suen, MMedSc
- Número de teléfono: 650-723-5728
- Correo electrónico: smy822@stanford.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Determine the acceptability of the Large Language Model generated audiobook
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
To assess the degree to which participants identified with the protagonist of the personalized audio picture book.
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Samuel Rodriguez, MD, Stanford University
- Investigador principal: Thomas Caruso, MD,PhD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 87422
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .