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- Klinische proef NCT07590791
Shared Reading for Pediatric Ophthalmic Education
Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hsin-Ming Liu
- Telefoonnummer: +886-965873185
- E-mail: angela89154@gmail.com
Studie Locaties
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Taiwan
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Taipei, Taiwan, Taiwan, 10449
- Mackay Memorial Hospital
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Contact:
- Department of Ophthalmology
- Telefoonnummer: 886-2-2543-3535
- E-mail: mmhopheye@gmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Leaflet
Standard printed educational leaflet
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Standard printed educational leaflet for cycloplegic refraction exam.
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Actieve vergelijker: Book
Commercially available children's book (Maisy Goes to the Eye Doctor) for parent-child shared reading
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Maisy Goes to the Eye Doctor
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Experimenteel: Customized book
Customized educational book on cycloplegic drops and refraction procedures, designed via generative AI, also for parent-child shared reading
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Generative AI-customized educational book focusing on cycloplegic administration and optometric examination.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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visual analogue scale of anxiety
Tijdsspanne: 1. Baseline, pre-intervention 2. 30 minutes after the intervention
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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."
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1. Baseline, pre-intervention 2. 30 minutes after the intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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children's emotional manifestation scale (CEMS)
Tijdsspanne: 30 minutes after the intervention
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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.
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30 minutes after the intervention
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Parent Satisfaction Scale
Tijdsspanne: 30 minutes after the intervention
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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. |
30 minutes after the intervention
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Staff Satisfaction Scale
Tijdsspanne: 30 minutes after the intervention
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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. |
30 minutes after the intervention
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 26MMHIS067e
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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