Shared Reading for Pediatric Ophthalmic Education

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vision Screening; Cycloplegic Refraction; Children Aged 3-5 Years
• Intervention / Treatment: Behavioral: standard printed educational leaflet; Behavioral: Commercially available children's book; Behavioral: Generative AI-customized educational book

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsin-Ming Liu; Phone Number: +886-965873185; Email: angela89154@gmail.com

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 10449
      • Mackay Memorial Hospital
      • Contact: Department of Ophthalmology; Phone Number: 886-2-2543-3535; Email: mmhopheye@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Leaflet; Standard printed educational leaflet	Behavioral: standard printed educational leaflet; Standard printed educational leaflet for cycloplegic refraction exam.
Active Comparator: Book; Commercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading	Behavioral: Commercially available children's book; Maisy Goes to the Eye Doctor
Experimental: Customized book; Customized educational book on cycloplegic drops and refraction procedures, designed via generative AI, also for parent-child shared reading	Behavioral: Generative AI-customized educational book; Generative AI-customized educational book focusing on cycloplegic administration and optometric examination.; Other Names: Maisy Goes to the Eye Doctor; Standard printed educational leaflet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale of anxiety	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
children's emotional manifestation scale (CEMS)	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	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	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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26MMHIS067e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No