NCT07071285

Brief Summary

This study aims to explore the impact of interactive breastfeeding e-books on nursing students' breastfeeding learning outcomes. The subjects are third-year nursing students from a university in central Taiwan. A randomized controlled design will be adopted. The experimental group will use interactive breastfeeding e-books for learning, while the control group will use traditional face-to-face courses to evaluate the changes in students' breastfeeding knowledge, skills, and learning motivation. The expected results can provide a reference for innovative teaching models in nursing education and promote the future clinical promotion of breastfeeding.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

11 days

First QC Date

July 8, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

e-booknursing educationlearning motivationBreastfeeding EducationNursing Students

Outcome Measures

Primary Outcomes (5)

  • Breastfeeding Knowledge Questionnaire

    This questionnaire consists of 10 multiple-choice questions. Each correct answer is scored 10 points, and each incorrect answer is scored 0 points, yielding a total score range of 0-100. The questions were self-developed in the form of clinical scenario-based multiple-choice items, focusing on the benefits of breastfeeding, breastfeeding positions, breast milk storage methods, breast milk expression (hand expression), and nursing interventions to maintain milk supply.

    The experimental group and the control group will Baseline (prior to intervention), immediately after intervention, and 4 weeks after intervention

  • Breastfeeding Skills Assessment Scale

    Breastfeeding skills were assessed using a "Breastfeeding Skills Assessment Scale," which includes 20 steps such as hand hygiene before procedures, self-introduction, patient identification, ensuring privacy, explaining the purpose and process, breastfeeding positions, and hand expression techniques. Each step is scored as follows: completely correct = 5 points, partially correct = 3 points, and incorrect = 0 points. The total score ranges from 0-100, with higher scores indicating better application of breastfeeding skills.

    The experimental group and the control group will Baseline (prior to intervention), immediately after intervention, and 4 weeks after intervention

  • Breastfeeding Self-Efficacy Scale

    Breastfeeding self-efficacy was evaluated using a 10-item Breastfeeding Self-Efficacy Scale. Each item is rated on a 4-point Likert scale, where 1 = not at all capable and 4 = expert level. The total score ranges from 10 to 40, with higher scores indicating greater self-efficacy in performing breastfeeding skills.

    The experimental group and the control group will Baseline (prior to intervention), immediately after intervention, and 4 weeks after intervention

  • ARCS-Based Learning Motivation Scale

    The scale assesses learners' motivation toward the educational materials across four dimensions: Attention (12 items), Relevance (9 items), Confidence (9 items), and Satisfaction (6 items), for a total of 36 items. Responses are rated on a 5-point Likert scale, ranging from 5 ("Strongly Agree") to 1 ("Strongly Disagree"). The total score ranges from 36 to 180 points, with higher scores indicating stronger learning motivation.

    The experimental group and the control group will Baseline (prior to intervention), immediately after intervention, and 4 weeks after intervention

  • Critical Thinking Disposition Scale

    This scale consists of 20 items and adopts a 6-point Likert scoring method: 1 (Never), 2 (Almost Never), 3 (Rarely), 4 (Sometimes), 5 (Often), and 6 (Always). It measures critical thinking disposition, which refers to an individual's tendency to engage in systematic analysis, maintain an open-minded attitude with empathy, and possess a wise curiosity for questioning, integration, and reflection, all of which facilitate critical thinking processes.

    The experimental group and the control group will Baseline (prior to intervention), immediately after intervention, and 4 weeks after intervention

Study Arms (2)

E-book

EXPERIMENTAL

Breastfeeding eBook learning mode.

Behavioral: E-Book

face-to-face teaching

ACTIVE COMPARATOR

face-to-face teaching of breastfeeding

Behavioral: face-to-face teaching

Interventions

E-BookBEHAVIORAL

Breastfeeding eBook learning mode.

E-book

face-to-face teaching of breastfeeding

face-to-face teaching

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • It is expected to include 100 people.
  • Age 20 to 30 years old.
  • A third-year nursing student.
  • Studying obstetrics and gynecology nursing this semester.
  • Agree to participate in this study and sign the research consent form.

You may not qualify if:

  • Students who are planning to take a leave of absence at the time of data collection.
  • Students who have not taken obstetrics and gynecology nursing this semester or have taken it in the past.
  • Students who are unable to use 3C products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taiwan, 406040, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study design will adopt a randomized controlled trial with repeated measures. A 60-minute intervention has been developed.Block randomization stratified by gender will be used, and eligible participants will be randomly assigned to either the experimental or control group in a 1:1 ratio using Random Allocation Software.Research assistants will code group assignments ("Group 1" and "Group 2") according to the randomization list, place the assignments into opaque sealed envelopes, and arrange them sequentially.On the day of the study, envelopes will be distributed in the order participants submit their consent forms. Participants will open the envelope themselves to learn their group assignment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

September 19, 2025

Primary Completion

September 30, 2025

Study Completion (Estimated)

July 31, 2026

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations