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NCT Number: NCT07590791

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Generative AI-customized educational book

Behavioral

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

Other names: Maisy Goes to the Eye Doctor, Standard printed educational leaflet

standard printed educational leaflet

Behavioral

Standard printed educational leaflet for cycloplegic refraction exam.

Commercially available children's book

Behavioral

Maisy Goes to the Eye Doctor

Primary outcomes

  1. visual analogue scale of anxiety

    Time frame: 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."

Secondary outcomes

  1. children's emotional manifestation scale (CEMS)

    Time frame: 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.

  2. Parent Satisfaction Scale

    Time frame: 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.

  3. Staff Satisfaction Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsin-Ming Liu

CONTACT

[email protected]

+886-965873185

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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