- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07590791
Shared Reading for Pediatric Ophthalmic Education
Generative AI-Mediated Shared Reading for Pediatric Ophthalmic Education
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hsin-Ming Liu
- Telefonnummer: +886-965873185
- E-post: angela89154@gmail.com
Studieorter
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-
Taiwan
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Taipei, Taiwan, Taiwan, 10449
- Mackay Memorial Hospital
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Kontakt:
- Department of Ophthalmology
- Telefonnummer: 886-2-2543-3535
- E-post: mmhopheye@gmail.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Leaflet
Standard printed educational leaflet
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Standard printed educational leaflet for cycloplegic refraction exam.
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Aktiv komparator: 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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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
visual analogue scale of anxiety
Tidsram: 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."
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1. Baseline, pre-intervention 2. 30 minutes after the intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
children's emotional manifestation scale (CEMS)
Tidsram: 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.
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30 minutes after the intervention
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Parent Satisfaction Scale
Tidsram: 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. |
30 minutes after the intervention
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Staff Satisfaction Scale
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 26MMHIS067e
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