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Shared Reading for Pediatric Ophthalmic Education

Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07590791
Enrollment
60
Registered
2026-05-15
Start date
2026-05-26
Completion date
2026-10-31
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Aged 3-5 Years, Cycloplegic Refraction, Vision Screening

Brief summary

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.

Interventions

BEHAVIORALGenerative AI-customized educational book

Generative AI-customized educational book focusing on cycloplegic administration and optometric examination.

BEHAVIORALstandard printed educational leaflet

Standard printed educational leaflet for cycloplegic refraction exam.

BEHAVIORALCommercially available children's book

Maisy Goes to the Eye Doctor

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale of anxiety1. Baseline, pre-intervention 2. 30 minutes after the interventionPediatric 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."

Secondary

MeasureTime frameDescription
children's emotional manifestation scale (CEMS)30 minutes after the interventionThis 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.
Parent Satisfaction Scale30 minutes after the interventionThe 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.
Staff Satisfaction Scale30 minutes after the interventionThe 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.

Countries

Taiwan

Contacts

CONTACTHsin-Ming Liu
angela89154@gmail.com+886-965873185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026