Integrating AI-Assisted Design Thinking Into Nursing Education

August 14, 2026 updated by: Carmen Chan Yip Wing-han, Chinese University of Hong Kong

Integrating Design Thinking Into Undergraduate Nursing Education to Nurture Empathy and Enhance Empathetic Communication: a Wait List RCT

The goal of this randomized controlled trial is to test whether an AI-assisted design thinking workshop can improve empathetic communication in undergraduate nursing students at The Chinese University of Hong Kong. The main questions it aims to answer are:

Does the workshop improve students' empathy, creativity, collaboration, problem-solving, and patient-centred care attitudes?

How do students experience the design thinking and AI-supported learning activities?

Researchers will compare the intervention group with a wait-list control group to see whether the workshop leads to better outcomes.

Participants will:

complete a baseline questionnaire before the workshop;

be randomly assigned to receive the workshop now or later;

attend two tutorials in the intervention group, including design thinking activities and AI-simulated clinical scenarios;

complete a follow-up questionnaire after the workshop;

and, for some participants, join a short interview about their learning experience.

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.

Detailed Description

The study uses a mixed-methods, wait-list randomized controlled trial to evaluate an AI-assisted design thinking workshop for undergraduate nursing students. First, an AI chatbot is co-designed in Phase 1 with 8 nursing faculty members and 8-10 students through a 3-hour workshop, followed by 4-6 weeks of chatbot development and validation. The workshop uses design thinking activities including empathy mapping, patient journey mapping, "How Might We" framing, prototyping, and feedback gathering to define learning needs and chatbot functions. The IT team then builds the chatbot using the workshop outputs, including scenario scripts, response frameworks, assessment criteria, and bilingual English/Cantonese requirements. In Phase 2, 80 eligible Year 2 nursing students are randomly assigned to an intervention group or a wait-list control group. All participants complete baseline and post-intervention questionnaires measuring empathy, creativity, collaboration, problem-solving, and patient-centred care attitudes. The intervention group receives two 90-minute tutorials: one on design thinking fundamentals and one on AI-simulated clinical scenarios. During the second tutorial, students rotate through different scenarios while tutors provide small-group guidance. Participants in the intervention group may also take part in semi-structured interviews to describe their experiences. Quantitative data will be summarized descriptively, and qualitative data from interviews, open-ended responses, and workshop observations will be analyzed using content analysis.

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.
80

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.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Nethersole School of Nursing, The Chinese University of Hong Kong

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

Description

Inclusion Criteria:

  • Undergraduate nursing students enrolled in the Bachelor of Nursing programme at CUHK Nethersole School of Nursing.
  • Enrolled in the NURS 3127 course during the 2026-27 academic year.
  • Willing and able to provide verbal informed consent and participate voluntarily in the study.

Exclusion Criteria:

  • Students with prior participation in design-thinking workshops.

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: Single

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: Intervention Group
The intervention arm will receive an AI-assisted design thinking workshop aimed at strengthening empathetic communication in nursing education. The workshop includes two structured tutorials: the first introduces the design thinking process through activities such as empathy mapping, patient journey mapping, "How Might We" framing, and rapid paper prototyping based on real clinical communication challenges. The second tutorial uses a customized conversational AI chatbot to simulate patient scenarios, allowing students to practice responses in a safe learning environment. During the session, tutors will rotate among groups to provide small-group guidance, feedback, and debriefing. The intervention is intended to help students build empathy, creative thinking, collaboration, and patient-centred communication skills.
Other: AI-assisted design thinking workshop
This intervention is distinct because it combines design thinking with a conversational AI chatbot to teach empathy in undergraduate nursing education. Rather than using lectures or standard simulation alone, it places students in an active, human-centred learning process that begins with empathy mapping and patient journey mapping, then moves to ideation, prototyping, and reflection. The chatbot provides realistic, bilingual clinical communication scenarios and immediate tailored feedback, including difficult situations such as breaking bad news, managing non-compliance, and responding to emotional or culturally complex encounters. The workshop is also developed through co-design with faculty and students, making the intervention closely aligned with actual learning needs and course context. In addition, the study uses a wait-list randomized controlled design, allowing comparison with usual learning while ensuring all students can eventually receive the workshop.
Other: Wait-list control group
The wait-list control group will complete the same baseline and follow-up questionnaires as the intervention group but will not receive the workshop during the main study period. Instead, they will continue with their usual learning activities and will be offered the AI-assisted design thinking workshop after the study data collection is completed.
Other: AI-assisted design thinking workshop
This intervention is distinct because it combines design thinking with a conversational AI chatbot to teach empathy in undergraduate nursing education. Rather than using lectures or standard simulation alone, it places students in an active, human-centred learning process that begins with empathy mapping and patient journey mapping, then moves to ideation, prototyping, and reflection. The chatbot provides realistic, bilingual clinical communication scenarios and immediate tailored feedback, including difficult situations such as breaking bad news, managing non-compliance, and responding to emotional or culturally complex encounters. The workshop is also developed through co-design with faculty and students, making the intervention closely aligned with actual learning needs and course context. In addition, the study uses a wait-list randomized controlled design, allowing comparison with usual learning while ensuring all students can eventually receive the workshop.

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
Empathy
Time Frame: The baseline assessment will be completed one week before the workshop. The post-intervention assessment will be completed within one week after the second tutorial at 12 weeks from enrollment.
Empathy will be measured with the Jefferson Scale of Empathy-Health Professions Student Version (JSE-HPS) which yields total scores ranging from 20 to 140; higher scores indicate greater empathy.
The baseline assessment will be completed one week before the workshop. The post-intervention assessment will be completed within one week after the second tutorial at 12 weeks from enrollment.

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
Creativity, collaboration, problem-solving
Time Frame: The baseline assessment will be completed one week before the workshop. The post-intervention assessment will be completed within one week after the second tutorial at 12 weeks from enrollment.
Creativity, collaboration, and problem-solving will be measured with the Student Engagement Questionnaire (SEQ). Each domain comprises two items rated on a 5-point Likert scale. The mean score for each domain will range from 1 to 5, with higher scores indicating greater perceived creativity, collaboration, and problem-solving ability.
The baseline assessment will be completed one week before the workshop. The post-intervention assessment will be completed within one week after the second tutorial at 12 weeks from enrollment.
Patient-centred care attitudes
Time Frame: The baseline assessment will be completed one week before the workshop. The post-intervention assessment will be completed within one week after the second tutorial at 12 weeks from enrollment. .
Patient-centred care attitudes will be measured using the Patient-Practitioner Orientation Scale (PPOS), an 18-item instrument comprising the sharing and caring subscales. Items are rated on a 6-point Likert scale, and the overall score will be calculated as the mean of all item scores, ranging from 1 to 6. Higher scores indicate more patient-centred care attitudes.
The baseline assessment will be completed one week before the workshop. The post-intervention assessment will be completed within one week after the second tutorial at 12 weeks from enrollment. .
Experiences and views on the workshop
Time Frame: After intervention, at 12 weeks from enrollment.
Evaluate by semi-structured interviews on the Intervention group
After intervention, at 12 weeks from enrollment.

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.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmen WH Chan, PhD, The Nethersole School of Nursing, The Chinese University of Hong Kong

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.
August 25, 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.
May 24, 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.
August 24, 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).
August 1, 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.
August 14, 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.
August 17, 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.
August 17, 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.
August 14, 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.
August 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.
  • TDLEG_496_PR
  • SBRE-25-1206 (Other Identifier: Survey and Behavioral Research Ethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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