ClinicalTrials.gg
Not yet recruitingNCT07590791Updated May 15, 2026

Shared Reading for Pediatric Ophthalmic Education

An interventional study of Generative AI-customized educational book and standard printed educational leaflet in Children Aged 3-5 Years, Vision Screening and Cycloplegic Refraction, sponsored by Mackay Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
3 Years to 5 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Children Aged 3-5 Years
  • Vision Screening
  • Cycloplegic Refraction
03

In context

Lead sponsor

Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    Leaflet

    Standard printed educational leaflet

    Behavioral: standard printed educational leaflet

  • 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

  • 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

Interventions

  • BehavioralGenerative AI-customized educational book

    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

  • Behavioralstandard printed educational leaflet

    Standard printed educational leaflet for cycloplegic refraction exam.

  • BehavioralCommercially available children's book

    Maisy Goes to the Eye Doctor

06

What researchers measure

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."

    Time frame: 1. Baseline, pre-intervention 2. 30 minutes after the intervention

Secondary outcomes

  1. 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.

    Time frame: 30 minutes after the intervention

  2. 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.

    Time frame: 30 minutes after the intervention

  3. 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.

    Time frame: 30 minutes after the intervention

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Oct 2026, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2026
First posted
May 15, 2026
StartEst.
May 26, 2026
Primary completionEst.
Oct 26, 2026
CompletionEst.
Oct 31, 2026
Last update
May 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07590791
Responsible party
Hsin-Ming Liu (Attending Physician, Department of Ophthalmology, Mackay Memorial Hospital) — Principal investigator
First posted
May 15, 2026
Start date
May 26, 2026 (estimated)
Primary completion
Oct 26, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
May 15, 2026

Study contacts

Hsin-Ming Liu
Contact
angela89154@gmail.com
+886-965873185

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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