A Multidimensional Intervention to Improve Ethical Decision-Making Competence Among Nursing Student Interns

November 5, 2026 updated by: Qiuyu Zhang, Yangzhou University

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:

  1. Does the 5-week multidimensional intervention improve ethical decision-making competence among nursing student interns compared with usual clinical internship training?
  2. 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:

  1. 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.
  2. Participate in the educational activities provided to their assigned study group.
  3. Complete follow-up assessments as scheduled.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Undergraduate nursing student interns undertaking clinical internships at tertiary Grade A hospitals.
  2. First-time hospital interns with no more than 3 months of internship experience.
  3. Good communication and language expression skills.
  4. Willingness to participate in the study and provide informed consent.

Exclusion Criteria:

  1. Individuals with a history of mental illness or communication difficulties.
  2. Nursing student interns who discontinue their hospital internship or take a leave of absence from their studies during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Multidimensional Intervention Group

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.

Other: Usual Clinical Internship Training Group

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.
Active Comparator: 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.
Other: Usual Clinical Internship Training Group

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ethical Decision-Making Competence Scale
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clance Impostor Phenomenon Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YXYLL-2025-140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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