An interventional study of Blended-learning capsules and High-Fidelity Physical Simulation in Parkinson Disease (PD), sponsored by University of Cadiz. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University of Cadiz · Not applicable, Interventional, and Other
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:
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:
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:
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 84 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Cadiz is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental Group (EG) will perform a multimodal simulation experience.
Other: Blended-learning capsules · Other: High-Fidelity Physical Simulation · Other: Simulated Home Environment
Control Group will participate in a standard workshop on physiological ageing using GERT® simulators.
Digital learning modules covering PD pathophysiology and authentic patient testimonials through audiovisual pills co-developed with the "Santa Adela" Parkinson's Association
Using GERT® geriatric suits specifically configured to simulate PD symptoms.
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
Clinical empathy
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.
Time frame: Day 1 (pretest) and Day 3 (post-test).
Awareness of Parkinson Disease quality of life
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.
Time frame: Day 1 (pretest) and Day 3 (post-test).
Learning perception
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.
Time frame: Day 3 (post-test).
Satisfaction with the simulations
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.
Time frame: Day 3 (post-test).
Plan to share: Yes — 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.
Supporting information: Study protocol
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Cadiz