Children Aged 3-5 YearsNCT07590791
Shared Reading for Pediatric Ophthalmic Education
A study testing Generative AI-customized educational book, standard printed educational leaflet and Commercially available children's book in people with Children Aged 3-5 Years and Vision Screening, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Children Aged 3-5 Years, Vision Screening, Cycloplegic Refraction
- What is being tested?
- Generative AI-customized educational book, standard printed educational leaflet and Commercially available children's book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 May 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
MacKay Memorial Hospital
Taipei, Taiwan, 10449
Department of Ophthalmology, 886-2-2543-3535, mmhopheye@gmail.com
About this study
Official title: 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.
- Being tested
- Generative AI-customized educational book, standard printed educational leaflet, Commercially available children's book
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generative AI-customized educational bookBehavioural
Also called Maisy Goes to the Eye Doctor, Standard printed educational leaflet
Generative AI-customized educational book focusing on cycloplegic administration and optometric examination.
standard printed educational leafletBehavioural
Standard printed educational leaflet for cycloplegic refraction exam.
Commercially available children's bookBehavioural
Maisy Goes to the Eye Doctor
| Study group | Role | What they receive |
|---|---|---|
| Leaflet | Placebo comparator | Standard printed educational leaflet Receives: Behavioral: standard printed educational leaflet |
| Book | Active comparator | Commercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading Receives: 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 Receives: Behavioral: Generative AI-customized educational book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 1. Baseline, pre-intervention 2. 30 minutes after the intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 30 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start26 May 2026 (estimated)
- Primary completion26 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Aged 3-5 YearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Ming Liu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590791
- Sponsor's protocol ID
- 26MMHIS067e
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education
- ClinicalTrials.gov ID
- NCT07590791
- Acronym / sponsor ID
- 26MMHIS067e
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 26 May 2026 (estimated)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leaflet | Placebo comparator | Behavioral: standard printed educational leafletStandard printed educational leaflet |
| Book | Active comparator | Behavioral: Commercially available children's bookCommercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading |
| Customized book | Experimental | Behavioral: Generative AI-customized educational bookCustomized educational book on cycloplegic drops and refraction procedures, designed via generative AI, also for parent-child shared reading |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generative AI-customized educational bookAlso: Maisy Goes to the Eye Doctor, Standard printed educational leafletGenerative AI-customized educational book focusing on cycloplegic administration and optometric examination. | Behavioural | Customized book |
| standard printed educational leafletStandard printed educational leaflet for cycloplegic refraction exam. | Behavioural | Leaflet |
| Commercially available children's bookMaisy Goes to the Eye Doctor | Behavioural | Book |
Primary outcome
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."
3 secondary outcomes
children's emotional manifestation scale (CEMS)
Time frame: 30 minutes after the intervention
Parent Satisfaction Scale
Time frame: 30 minutes after the intervention
Staff Satisfaction Scale
Time frame: 30 minutes after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Children Aged 3-5 Years
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
Active Juvenile Psoriatic Arthritis
Not yet recruiting
Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education
Dietary Intakes, Physical Activity
Not yet recruiting
TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
Cradle Cap, Seborrheic Dermatitis
RecruitingPhase 3
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
Juvenile Psoriatic Arthritis
Not yet recruitingPhase 3
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
Irritability Associated With Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Generative AI-customized educational book, standard printed educational leaflet and Commercially available children's book in people with Children Aged 3-5 Years and Vision Screening, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Ming Liu (+886-965873185, angela89154@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale of anxiety (time frame: 1. Baseline, pre-intervention 2. 30 minutes after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.