Enhancing Nursing Students' Empathy and Learning in Parkinson's Disease Through High-Fidelity Simulation and Blended Learning

March 25, 2026 updated by: Antonio Jesús Marín Paz, University of Cadiz

Enhancing Nursing Students' Empathy and Learning in Parkinson's Disease Through High-Fidelity Simulation and Blended Learning: A Randomised Controlled Trial

The goal of this randomized controlled trial is to evaluate the effectiveness of a multimodal Parkinson's disease-focused intervention on empathy levels and perceived theoretical-practical learning in third-year undergraduate nursing students.

The main questions it aims to answer are:

  • Will students receiving the multimodal intervention demonstrate significantly higher levels of clinical empathy compared to those receiving standard simulation-based workshops?
  • Will the intervention significantly improve awareness of Parkinson's disease (PD) quality of life and the internalisation of the patient's lived experience?

Researchers will compare the experimental group, which receives a multimodal approach including blended learning and a simulated home environment, to a control group receiving standard simulation workshops on physiological aging to see if the multimodal strategy offers superior outcomes in clinical awareness and empathy development.

Participants will:

  • Attend a two-hour initial theoretical session regarding neurodegenerative disorders and nursing care.
  • Complete digital blended-learning micro-capsules covering PD pathophysiology and authentic patient testimonials (Experimental Group only).
  • Engage in high-fidelity physical simulation using GERT® suits to perform activities of daily living (e.g., dressing, eating, and walking) within either a recreated domestic environment or a standard classroom setting.
  • Participate in a structured debriefing session focused on reflective analysis of the emotional and functional impact of Parkinson's symptoms.
  • Complete validated self-administered instruments during pretest and posttest phases to measure empathy, satisfaction, and perception of learning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study describes a randomized controlled trial designed to address the urgent need for specialized nursing education as the global prevalence of Parkinson's disease (PD) continues to rise. Researchers aim to evaluate how a multimodal intervention-combining digital learning with immersive simulation-affects the clinical empathy and theoretical-practical understanding of third-year nursing students.

The challenge of Parkinson's Disease Parkinson's disease is a complex neurodegenerative disorder characterized by an unpredictable array of motor and non-motor symptoms. As the global burden of PD is projected to double by 2040, healthcare systems require nurses who possess not only technical skills but also a deep, humanized understanding of the patient's lived experience. Traditional educational methods often leave a gap in preparing students for the specific challenges of person-centered neurodegenerative care.

Study Design and Participants The study will involve 84 third-year nursing students from the University of Cadiz in Spain. These participants will be randomly assign to either a control group or an experimental group. While both groups will receive two hours of initial theoretical instruction on neurodegenerative disorders, their practical training will differ significantly.

The Multimodal Intervention

The experimental group will participate in a comprehensive, high-fidelity simulation experience designed to maximize psychological fidelity. This multimodal approach includes three key components:

  • Blended-Learning Capsules: Students will access digital modules featuring authentic patient testimonials to provide a real-world context for PD pathophysiology.
  • GERT® Geriatric Suits: Students will wear specialized suits designed to physically simulate the motor limitations and tremors associated with PD.
  • Simulated Home Environment: Unlike the control group, who will practice in a standard classroom, the experimental group will perform activities of daily living-such as eating, dressing, and walking-within a room designed to look like a domestic home.

Following these activities, all students will participate in a structured debriefing, a reflective session where they will analyze the emotional and functional impact of the symptoms they will experience.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • 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 Locations

  • Spain
    • Cadiz
      • Algeciras, Cadiz, Spain, 11207
        • Faculty of Nursing

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Third-year undergraduate nursing students enrolled in Geriatric Nursing subject from a Faculty of Nursing of the University of Cadiz (Spain).

Exclusion Criteria:

  • Participants who do not wish to take part in the study.

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
Intervention / Treatment
Experimental: Experimental group
Experimental Group (EG) will perform a multimodal simulation experience.
Other: Blended-learning capsules
Digital learning modules covering PD pathophysiology and authentic patient testimonials through audiovisual pills co-developed with the "Santa Adela" Parkinson's Association
Other: High-Fidelity Physical Simulation
Using GERT® geriatric suits specifically configured to simulate PD symptoms.
Other: Simulated Home Environment
The EG simulation workshop was delivered in a home-visit simulation room designed to resemble a domestic setting, furnished with household-style equipment and furniture
No Intervention: Control Group
Control Group will participate in a standard workshop on physiological ageing using GERT® simulators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical empathy
Time Frame: Day 1 (pretest) and Day 3 (post-test).
Clinical empathy will be measured by the Jefferson Scale of Physician Empathy (JSPE), validated into Spanish. It is made up of 20 items with scoring using a 7-points Likert scale (1 = strongly disagree, 7 = strongly agree). Ten of the 20 questions are valued negatively (and rectified positively in the subsequent analysis), in order to reduce the effect of acquiescence when responding. The range of possible scores goes from 20 to 140 points. The highest scores are associated with a greater degree of empathy.
Day 1 (pretest) and Day 3 (post-test).
Awareness of Parkinson Disease quality of life
Time Frame: Day 1 (pretest) and Day 3 (post-test).
It will measure by the Parkinson's Disease Questionnaire (PDQ-39), validated into Spanish. The PDQ-39 questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. Although it is an instrument originally conceived as a patient-reported measure of health-related quality of life, students will asked to complete it by "taking the perspective" as if they were patients with the disease. Scores are expressed as a percentage, ranging from 0 (never have difficulty) to 100 (always have difficulty), with lower scores indicating better quality of life and higher scores indicating greater impairment.
Day 1 (pretest) and Day 3 (post-test).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning perception
Time Frame: Day 3 (post-test).
It will measure by the Educational Practices Questionnaire (EPQ). The scale consists of sixteen questions divided into the following subscales: Active Learning (items 1-10), Collaboration (items 11 and 12), Diverse Learning Methods (items 13 and 14), and High Expectations (items 15 and 16). Furthermore, the scale is divided into two parts. One of these concerns the presence of statements given during simulation classes (EPQ-PO), and the other one concerns their validity, in the student's opinion, during the classes (EPQ-IO). Higher scores mean greater recognition of educational best practices in simulations.
Day 3 (post-test).
Satisfaction with the simulations
Time Frame: Day 3 (post-test).
It will measure by the Spanish version of the High-Fidelity Simulation Satisfaction Scale for Students (ESSAF). This scale contains 33 statements answered on a 5-point Likert-type scale, with a minimum score of 1 (strongly disagree) to 5 (strongly agree). The 33 items are grouped into 8 dimensions of student perception of clinical simulation: "Usefulness", "Characteristics of cases and applications", "Communication", "Perceived performance", "Increased self-confidence", "Relationship between theory and practice", "Facilities and equipment" and "Negative aspects". Higher scores indicating greater satisfaction.
Day 3 (post-test).

Collaborators and Investigators

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

Sponsor

University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2025

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEENB-OMGs-018_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The dataset compiled during the study, which has been appropriately processed to ensure the anonymity of the participants, will be made openly available when the study results are published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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