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Shared Reading for Pediatric Ophthalmic Education

12. maj 2026 opdateret af: Hsin-Ming Liu, Mackay Memorial Hospital

Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education

We use generative AI to make personalized books for young children about going to the eye doctor. We want to see if reading these stories helps kids feel more comfortable and improves their overall experience at the clinic.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Taiwan
      • Taipei, Taiwan, Taiwan, 10449
        • Mackay Memorial Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Children aged 3 to 5 years.
  • Parents or legal guardians capable of participating in parent-child shared reading (proficient in Traditional Chinese).
  • Agreement to the administration of cycloplegic agents.

Exclusion Criteria:

  • Parents or legal guardians who are not proficient in Traditional Chinese or are unwilling to participate in parent-child shared reading.
  • Children aged under 3 years or 6 years and older.
  • Refusal of cycloplegic agent administration.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Leaflet
Standard printed educational leaflet
Standard printed educational leaflet for cycloplegic refraction exam.
Aktiv komparator: Book
Commercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading
Maisy Goes to the Eye Doctor
Eksperimentel: Customized book
Customized educational book on cycloplegic drops and refraction procedures, designed via generative AI, also for parent-child shared reading
Generative AI-customized educational book focusing on cycloplegic administration and optometric examination.
Andre navne:
  • Maisy Goes to the Eye Doctor
  • Standard printed educational leaflet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
visual analogue scale of anxiety
Tidsramme: 1. Baseline, pre-intervention 2. 30 minutes after the intervention
Pediatric anxiety levels will be quantified using a 0-10 scale supplemented by facial icons. Participants will be shown the scale and asked to select the face or number that best matches how they feel at that moment. The scale is anchored by "No anxiety" (0, happy face) and "Extreme anxiety" (10, distressed face). Research assistants will provide a standardized prompt: "Point to the face that shows how you feel right now."
1. Baseline, pre-intervention 2. 30 minutes after the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
children's emotional manifestation scale (CEMS)
Tidsramme: 30 minutes after the intervention
This observational instrument consists of five behavioral categories: facial expression, vocalization, activity, interaction, and cooperation. Each category is scored on a 5-point Likert scale (1 to 5), with a total score ranging from 5 to 25. Higher scores represent higher levels of emotional distress and negative behaviors.
30 minutes after the intervention
Parent Satisfaction Scale
Tidsramme: 30 minutes after the intervention

The Parent Satisfaction Scale is a 10-item self-report questionnaire designed to evaluate the caregiver's perception of the quality of pediatric ophthalmic care. The scale assesses several key domains of the clinical encounter, including patient-centered communication, emotional support, clinician-parent partnership, and overall service quality.

Scoring and Administration:

Each item is scored using a 5-point Likert scale, with response options ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). A total satisfaction score is calculated by summing the responses, with higher scores (ranging from 10 to 50) indicating higher levels of parental satisfaction with the healthcare delivery and the educational intervention provided.

30 minutes after the intervention
Staff Satisfaction Scale
Tidsramme: 30 minutes after the intervention

The Staff Satisfaction Scale is a 7-item clinician-reported instrument designed to evaluate the clinical feasibility and perceived quality of a pediatric eye examination. The scale measures the nurse's observation of patient cooperation, parental engagement, and the effectiveness of the clinical workflow.

Scoring and Administration:

Following the patient's encounter, the attending ophthalmic nurse rates each statement using a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Higher aggregate scores indicate a more efficient clinical process and a higher level of professional satisfaction with the care delivery.

30 minutes after the intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

26. maj 2026

Primær færdiggørelse (Anslået)

26. oktober 2026

Studieafslutning (Anslået)

31. oktober 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 26MMHIS067e

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Synsscreening

Kliniske forsøg med standard printed educational leaflet

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