Shared Reading for Pediatric Ophthalmic Education
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorMackay Memorial Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Generative AI-customized educational book
BehavioralGenerative AI-customized educational book focusing on cycloplegic administration and optometric examination.
standard printed educational leaflet
BehavioralStandard printed educational leaflet for cycloplegic refraction exam.
Commercially available children's book
BehavioralMaisy Goes to the Eye Doctor
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: LeafletPlacebo comparator 1 intervention
Group B: BookActive comparator 1 intervention
Group C: Customized bookExperimental treatment 1 intervention
Trial outcomes
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 interventionSecondary 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 intervention2
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 intervention3
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 interventionSponsors and contacts
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Source ClinicalTrials.gov
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