- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Qiuyu Zhang
- Número de telefone: +86 17334532770
- E-mail: mz120242155@stu.yzu.edu.cn
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ethical Decision-Making Competence Scale
Prazo: 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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Clance Impostor Phenomenon Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- YXYLL-2025-140
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