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NCT Number: NCT07503418

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

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.

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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Algeciras, Cadiz, 11207, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blended-learning capsules

Other

Digital learning modules covering PD pathophysiology and authentic patient testimonials through audiovisual pills co-developed with the "Santa Adela" Parkinson's Association

High-Fidelity Physical Simulation

Other

Using GERT® geriatric suits specifically configured to simulate PD symptoms.

Simulated Home Environment

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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