Shared Reading for Pediatric Ophthalmic Education

NCT07590791 | Not Yet Recruiting

• 1 other identifier: 26MMHIS067e
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• children's emotional manifestation scale (CEMS)

  30 minutes after the intervention

• Parent Satisfaction Scale

  30 minutes after the intervention

• Staff Satisfaction Scale

  30 minutes after the intervention

Study Arms (3)

Leaflet

PLACEBO COMPARATOR

Standard printed educational leaflet

Behavioral: standard printed educational leaflet

Book

ACTIVE COMPARATOR

Commercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading

Behavioral: Commercially available children's book

Customized book

EXPERIMENTAL

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

Interventions

Generative AI-customized educational book BEHAVIORAL

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

Also known as: Maisy Goes to the Eye Doctor, Standard printed educational leaflet

Customized book

standard printed educational leaflet BEHAVIORAL

Standard printed educational leaflet for cycloplegic refraction exam.

Leaflet

Commercially available children's book BEHAVIORAL

Maisy Goes to the Eye Doctor

Book

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, Taiwan, 10449, Taiwan

Location

Central Study Contacts

Hsin-Ming Liu

CONTACT

+886-965873185; angela89154@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Ophthalmology

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)