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

NCT07503418 | Completed

• 1 other identifier: CEENB-OMGs-018_2025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease (PD)

Keywords

Empathy; High Fidelity Simulation Training; Nursing Education Research; Parkinson Disease; Patient Simulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (2)

• Learning perception

  Day 3 (post-test).

• Satisfaction with the simulations

  Day 3 (post-test).

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental Group (EG) will perform a multimodal simulation experience.

Other: Blended-learning capsules; Other: High-Fidelity Physical Simulation; Other: Simulated Home Environment

Control Group

NO INTERVENTION

Control Group will participate in a standard workshop on physiological ageing using GERT® simulators.

Interventions

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

Experimental group

High-Fidelity Physical Simulation OTHER

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

Experimental group

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Faculty of Nursing

Algeciras, Cadiz, 11207, Spain

Location

Related Publications (16)

• 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.

  PMID: 19902660 BACKGROUND

• 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.

  PMID: 39285294 BACKGROUND

• 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.

  PMID: 39700839 BACKGROUND

• 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.

  PMID: 38701671 BACKGROUND

• 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.

  PMID: 39161697 BACKGROUND

• 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.

  PMID: 34486425 BACKGROUND

• 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.

  PMID: 33894193 BACKGROUND

• 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.

  PMID: 40044233 BACKGROUND

• 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.

  PMID: 9617722 BACKGROUND

• 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.

  PMID: 37770843 BACKGROUND

• 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.

  PMID: 35158134 BACKGROUND

• 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.

  PMID: 30739841 BACKGROUND

• 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.

  PMID: 40228477 BACKGROUND

• 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.

  PMID: 32941464 BACKGROUND

• 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.

  PMID: 37814245 BACKGROUND

• Baghaei A, Kim HS, Dolhun R, Sherzai D, Dashtipour K. Review of the Effects of Lifestyle Modification on Parkinson's Disease. Am J Lifestyle Med. 2025 Oct 3:15598276251384591. doi: 10.1177/15598276251384591. Online ahead of print.

  PMID: 41050191 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be blinded during the randomization of participants, the evaluation of the simulations and the statistical analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborator investigator

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: February 1, 2025
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)