- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07894653
A Multidimensional Intervention to Improve Ethical Decision-Making Competence Among Nursing Student Interns
The goal of this randomized controlled trial is to evaluate the effectiveness of a 5-week multidimensional intervention in improving ethical decision-making competence among nursing student interns. The intervention is designed to address multiple factors influencing ethical decision-making during clinical training. The study will also examine whether the effects of the intervention are maintained at 1-month and 3-month follow-ups after the intervention ends.
The main questions it aims to answer are:
- Does the 5-week multidimensional intervention improve ethical decision-making competence among nursing student interns compared with usual clinical internship training?
- Are the effects of the intervention maintained at 1-month and 3-month follow-ups after the intervention ends?
Researchers will compare nursing student interns who receive the 5-week multidimensional intervention with those who receive usual clinical internship training to evaluate the intervention's effectiveness.
Participants will:
- Complete questionnaires assessing all study outcome measures at baseline, at the end of the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention ends.
- Participate in the educational activities provided to their assigned study group.
- Complete follow-up assessments as scheduled.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Qiuyu Zhang
- Номер телефона: +86 17334532770
- Электронная почта: mz120242155@stu.yzu.edu.cn
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Undergraduate nursing student interns undertaking clinical internships at tertiary Grade A hospitals.
- First-time hospital interns with no more than 3 months of internship experience.
- Good communication and language expression skills.
- Willingness to participate in the study and provide informed consent.
Exclusion Criteria:
- Individuals with a history of mental illness or communication difficulties.
- Nursing student interns who discontinue their hospital internship or take a leave of absence from their studies during the study period.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Multidimensional Intervention Group
Participants assigned to this group will receive a 5-week multidimensional intervention designed to improve ethical decision-making competence among nursing student interns during clinical learning. The intervention will address factors relevant to ethical decision-making through structured educational activities. Participants will complete outcome assessments at baseline, at the end of the intervention, and at 1-month and 3-month follow-ups after the intervention ends. |
A 5-week multidimensional educational intervention to improve ethical decision-making competence among nursing student interns. Sessions will be delivered once weekly, lasting 1.5-2 hours each. The intervention includes five modules: (1) ethical issue recognition; (2) ethical emotion regulation; (3) ethical reasoning and decision-making; (4) ethical expression and action; and (5) clinical teaching rounds. The intervention aims to strengthen participants' ethical awareness, emotional regulation, decision-making, and ability to address ethical challenges during clinical learning. Participants in the usual clinical internship training group will receive routine clinical learning and teaching according to the hospital's established training program. Regular activities include clinical skills training, observation and participation in nursing care under the supervision of clinical instructors, case discussions. When encountering ethical issues during clinical learning, participants will generally seek advice from their clinical instructors or supervising nurses. No additional study-specific intervention will be provided. |
|
Активный компаратор: Usual Clinical Internship Training Group
Participants assigned to this group will receive usual clinical internship training according to the hospital's standard training arrangements. They will not receive the study-specific 5-week multidimensional intervention during the intervention period. Participants will complete outcome assessments at baseline, at the end of the 5-week intervention period, and at 1-month and 3-month follow-ups after the intervention period ends. |
Participants in the usual clinical internship training group will receive routine clinical learning and teaching according to the hospital's established training program. Regular activities include clinical skills training, observation and participation in nursing care under the supervision of clinical instructors, case discussions. When encountering ethical issues during clinical learning, participants will generally seek advice from their clinical instructors or supervising nurses. No additional study-specific intervention will be provided. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Ethical Decision-Making Competence Scale
Временное ограничение: At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
The scale consists of 18 items across four dimensions and assesses nursing students' creativity, confidence, awareness, and neutrality when facing ethical decision-making dilemmas involving patients or their families. It is based on Rest's Four-Component Model of Ethical Decision-Making, comprising ethical judgment, ethical sensitivity, ethical motivation, and ethical action. Each item is rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The total score ranges from 0 to 72, with higher scores indicating a higher level of ethical decision-making competence. |
At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Clance Impostor Phenomenon Scale
Временное ограничение: At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
This scale measures nurses' levels of imposter phenomenon and their attributions. It consists of 18 items across three dimensions: passive concealment (4 items), external attribution (6 items), and self-doubt (8 items). Each item is rated on a 5-point Likert scale ranging from 1 ("completely inconsistent") to 5 ("completely consistent"). The total score ranges from 18 to 90, with higher scores indicating a more severe imposter phenomenon. |
At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
|
Rushton Moral Resilience Scale
Временное ограничение: At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
The scale consists of 17 items across three dimensions: coping with nursing ethical dilemmas and relational integrity (10 items), personal integrity (2 items), and ethical efficacy in nursing (5 items). Each item is rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). The total score ranges from 17 to 68, with higher scores indicating greater ethical resilience. |
At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
|
Moral Sensitivity Questionnaire for Nursing Students
Временное ограничение: At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
This scale measures nursing students' moral sensitivity and consists of 11 items across three dimensions: moral strength (4 items), moral burden (5 items), and moral responsibility (2 items). Each item is rated on a 6-point Likert scale ranging from 1 ("strongly disagree") to 6 ("strongly agree"). The total score ranges from 11 to 66, with higher scores indicating greater moral sensitivity. |
At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
|
Professional Quality Of Life Scale
Временное ограничение: At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
The scale consists of three dimensions: compassion satisfaction (CS), burnout (BO), and secondary traumatic stress (STS). CS represents a positive aspect, whereas BO and STS represent negative aspects. Items are rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("always"). The cutoff scores for CS, BO, and STS are 27, and >17, respectively. Compassion fatigue severity is classified as mild when one dimension exceeds its cutoff, moderate when two dimensions exceed their cutoffs, and severe when all three dimensions exceed their cutoffs. |
At baseline, immediately after the 5-week intervention, and at 1-month and 3-month follow-ups after the intervention.
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- YXYLL-2025-140
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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