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Parkinson Disease (PD)NCT07503418

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

A study testing Blended-learning capsules, High-Fidelity Physical Simulation and Simulated Home Environment in people with Parkinson Disease (PD), run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
Blended-learning capsules, High-Fidelity Physical Simulation and Simulated Home Environment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSpain
Study dates
1 Feb 2025to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Faculty of Nursing

    Algeciras, Cadiz, 11207

Other trials in Spain

About this study

Official title: 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:

Read more
  • 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.
Read the 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.

Being tested
Blended-learning capsules, High-Fidelity Physical Simulation, Simulated Home Environment
Keywords
Empathy, High Fidelity Simulation Training, Nursing Education Research, Parkinson Disease, Patient Simulation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blended-learning capsulesOther

    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 SimulationOther

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

  • Simulated Home EnvironmentOther

    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

Study groups in NCT07503418
Study groupRoleWhat they receive
Experimental groupExperimentalExperimental Group (EG) will perform a multimodal simulation experience.
Receives: Other: Blended-learning capsules; Other: High-Fidelity Physical Simulation; Other: Simulated Home Environment
Control GroupNo interventionControl Group will participate in a standard workshop on physiological ageing using GERT® simulators.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 (pretest) and Day 3 (post-test).

  2. 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.

    Measured: Day 1 (pretest) and Day 3 (post-test).

Secondary outcomes (2)
  1. 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.

    Measured: Day 3 (post-test).

  2. 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.

    Measured: Day 3 (post-test).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start1 Feb 2025
  3. Primary completion31 May 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07503418
Sponsor's protocol ID
CEENB-OMGs-018_2025
Status last verified
Mar 2026
First submitted
25 Mar 2026
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Ward J, Schaal M, Sullivan J, Bowen ME, Erdmann JB, Hojat M. Reliability and validity of the Jefferson Scale of Empathy in undergraduate nursing students. J Nurs Meas. 2009;17(1):73-88. doi: 10.1891/1061-3749.17.1.73.

    PubMed 19902660
  • Wang Y, Wang C, Yang Z, Tang Y, Chen W, Zheng Y, Wei Z, Li H. Latent profile analysis of empathy ability and its relationship with professional quality of life among hospice nurses in China. BMC Nurs. 2024 Sep 16;23(1):658. doi: 10.1186/s12912-024-02299-9.

    PubMed 39285294
  • Wang R, Raman A. Systematic literature review on the effects of blended learning in nursing education. Nurse Educ Pract. 2025 Jan;82:104238. doi: 10.1016/j.nepr.2024.104238. Epub 2024 Dec 16.

    PubMed 39700839
  • Vangone I, Arrigoni C, Magon A, Conte G, Russo S, Belloni S, Stievano A, Alfes CM, Caruso R. The efficacy of high-fidelity simulation on knowledge and performance in undergraduate nursing students: An umbrella review of systematic reviews and meta-analysis. Nurse Educ Today. 2024 Aug;139:106231. doi: 10.1016/j.nedt.2024.106231. Epub 2024 Apr 30.

    PubMed 38701671
  • van Munster M, Czabanowska K, Clemens T, Wieczorek E, Pedrosa D, Mestre TA, Stumpel J. Priorities in healthcare provision in Parkinson's disease from the perspective of Parkinson Nurses: A focus group study. Int J Nurs Stud Adv. 2024 Jun 12;7:100213. doi: 10.1016/j.ijnsa.2024.100213. eCollection 2024 Dec.

    PubMed 39161697
  • Tosin MHS, Mecone CAC, Oliveira EFM, Tsui DS, Tan SB, Irene S, Oliveira BC, de Oliveira BGRB. Nursing and Parkinson's Disease: A Scoping Review of Worldwide Studies. Clin Nurs Res. 2022 Feb;31(2):230-238. doi: 10.1177/10547738211044047. Epub 2021 Sep 6.

    PubMed 34486425
  • Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.

    PubMed 33894193
  • Su D, Cui Y, He C, Yin P, Bai R, Zhu J, Lam JST, Zhang J, Yan R, Zheng X, Wu J, Zhao D, Wang A, Zhou M, Feng T. Projections for prevalence of Parkinson's disease and its driving factors in 195 countries and territories to 2050: modelling study of Global Burden of Disease Study 2021. BMJ. 2025 Mar 5;388:e080952. doi: 10.1136/bmj-2024-080952.

    PubMed 40044233
  • Martinez-Martin P, Frades Payo B. Quality of life in Parkinson's disease: validation study of the PDQ-39 Spanish version. The Grupo Centro for Study of Movement Disorders. J Neurol. 1998 May;245 Suppl 1:S34-8. doi: 10.1007/pl00007737.

    PubMed 9617722
  • Martinez-Arce A, Rodriguez-Almagro J, Velez-Velez E, Rodriguez-Gomez P, Tovar-Reinoso A, Hernandez-Martinez A. Validation of a short version of the high-fidelity simulation satisfaction scale in nursing students. BMC Nurs. 2023 Sep 28;22(1):344. doi: 10.1186/s12912-023-01515-2.

    PubMed 37770843
  • Li YY, Au ML, Tong LK, Ng WI, Wang SC. High-fidelity simulation in undergraduate nursing education: A meta-analysis. Nurse Educ Today. 2022 Apr;111:105291. doi: 10.1016/j.nedt.2022.105291. Epub 2022 Feb 3.

    PubMed 35158134
  • Levett-Jones T, Cant R, Lapkin S. A systematic review of the effectiveness of empathy education for undergraduate nursing students. Nurse Educ Today. 2019 Apr;75:80-94. doi: 10.1016/j.nedt.2019.01.006. Epub 2019 Jan 26.

    PubMed 30739841
  • Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: Updated guideline for reporting randomised trials. PLoS Med. 2025 Apr 14;22(4):e1004587. doi: 10.1371/journal.pmed.1004587. eCollection 2025 Apr.

    PubMed 40228477
  • Farres-Tarafa M, Roldan-Merino J, Lorenzo-Seva U, Hurtado-Pardos B, Biurrun-Garrido A, Molina-Raya L, Morera-Pomarede MJ, Bande D, Raurell-Torreda M, Casas I. Reliability and validity study of the Spanish adaptation of the "Educational Practices Questionnaire" (EPQ). PLoS One. 2020 Sep 17;15(9):e0239014. doi: 10.1371/journal.pone.0239014. eCollection 2020.

    PubMed 32941464
  • Crooks S, Stark P, Carlisle S, McMullan J, Copeland S, Wong WYA, Blake D, Lyons E, Campbell N, Carter G, Wilson CB, Mitchell G. Evaluation of a co-designed Parkinson's awareness audio podcast for undergraduate nursing students in Northern Ireland. BMC Nurs. 2023 Oct 9;22(1):370. doi: 10.1186/s12912-023-01544-x.

    PubMed 37814245

Questions about this trial

What is this clinical trial studying?

A study testing Blended-learning capsules, High-Fidelity Physical Simulation and Simulated Home Environment in people with Parkinson Disease (PD), run by University of Cadiz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical empathy (time frame: Day 1 (pretest) and Day 3 (post-test).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07503418, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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