Clinical trial NCT06852482: Simulation-based Education in Physiotherapy
Official title: Simulation-based Education for Physiotherapy Facilitators and Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Efficacy
Empathy
Keywords: Simulation based education
students
facilitators
physiotherapy
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This prospective quasi-experimental study has a mixed methodological design, of an explanatory sequential type, in which two phases are differentiated: 1) in the first phase, objective 1 will be worked on and will have a quantitative design; and 2) in the second phase, objective 2 will be worked on and will have a qualitative design.

Study population include students and facilitators in simulation-based education.
Primary purpose: OTHER

Brief summary: BACKGROUND: Simulation-based education (SBE) is a current teaching methodology characterized by providing realistic and effective environments, enhancing patient-professional clinical contact in a safe educational environment. Not all facilitators are trained to guide simulations in a systematic way. As a consequence, it is not possible to guarantee homogeneity of the methodology applied so that the simulations have better results in student learning.

OBJECTIVES: 1) To evaluate the impact of the BSE training of the Physiotherapy degree facilitators on their teaching self-efficacy; 2) To evaluate the impact of the BSE on the perceived self-efficacy, academic commitment and empathy of the 2nd, 3rd and 4th year Physiotherapy students; 3) To describe the degree of satisfaction and confidence in learning with respect to the BSE of the 2nd, 3rd and 4th year Physiotherapy students. The qualitative phase aims to know the experiences of Physiotherapy students regarding the EBS.

METHODOLOGY: Prospective quasi-experimental study of mixed methodology, in which simulation facilitators and students will be studied within the framework of the subjects Pràcticum I, III and V of the Physiotherapy degree of the FCSB. Students with a grade \<5 in any of the evaluative parts of these subjects and facilitators who have not completed the two proposed training sessions will be excluded. Demographic and teaching self-efficacy variables will be collected from the facilitators at 3 points in time: before and after the training and at the end of the period of simulations of Pràcticum I, III and V.

EXPECTED BENEFITS: The present mixed methodology project is expected to bring benefits in the training of the facilitators of the EBS of the Physiotherapy degree, better methodological quality of the EBS carried out in the subjects Pràcticum I, III and V of the same degree; iii) A favorable impact on the perceived self-efficacy, academic behavior and empathy of the second, third and fourth year students of the Physiotherapy Degree; iv) To know the degree of satisfaction and confidence for learning shown by students who perform EBS in the Degree of Physiotherapy; v) To know the students' perception of the best educational practices in EBS performed in the Degree of Physiotherapy; vi) To know the experiences of the students of the Degree of Physiotherapy with respect to EBS.

Detailed description: Clinical simulation has been shown to be a pedagogical tool that enhances students' self-confidence and facilitates the integration of fundamental practical skills acquired in the classroom, as well as "multidisciplinary skills" such as communication, collaboration and conflict resolution.

EBS can be approached using a variety of modalities, which are classified according to levels of complexity, fidelity or realism, resulting in three types: low, intermediate and high complexity. In all phases of the EBS, the facilitator guides the learner in planning (prebriefing) and conducting the simulation, establishes a safe learning environment, and facilitates reflection with debriefing.

For this reason, during the 2023-2024 academic year, training will be provided for the facilitators of the simulations in the Physiotherapy Degree, with the aim of providing tools and strategies for a more effective development of the EBS.

Methodology Study design This prospective quasi-experimental study has a mixed methodological design, of an explanatory sequential type, in which two phases are differentiated: 1) in the first phase, objective 1 will be worked on and will have a quantitative design; and 2) in the second phase, objective 2 will be worked on and will have a qualitative design. Both phases will be complementary.

Study population The study population will be the 2nd, 3rd and 4th year students of the Degree in Physiotherapy of the FCSB, who are enrolled in the subjects Practicum I, III or V of the Degree and who have received the EBS, as well as the tutors of such subjects who have a role as Facilitator in the Simulations.

Inclusion criteria: a) First enrollment in Practicum I, III or V subjects; b) Completion of the entire EBS session.

Exclusion criteria: a) Failure to obtain a grade \>5 in any of the evaluative parts of the subject.

Regarding the inclusion and exclusion criteria established for the population of facilitators:

Inclusion criteria: a) Facilitator of the simulations in Practicum I, III or V subjects.

Exclusion criteria: a) Not having completed the two training sessions.

Since this is a single-group quasi-experimental study, no randomization method will be applied to the study populations.

The recruitment process for the quantitative phase will be carried out, in both populations, orally and in writing through the information and informed consent form prepared for this project.

As for the Facilitator population, the same process of explanation will be applied in a briefing session by a member of the research team and they will receive a QR code to indicate, pseudo-anonymously and privately, whether or not they decide to participate in the study.

In the qualitative phase, convenience sampling will be used on the students included in the quantitative phase and who have taken the EBS.

Data Collection During Phase 1, quantitative data will be collected using the Forms extension of Microsoft 365, via a QR code that participants will receive.

Facilitating Variables:

Independent variables:

Sociodemographic data: subject (Practicum I, III, V), age, gender, previous training in EBS. These variables will be collected at baseline.

EBS training:

An intervention is proposed in two training days for tutors of the subjects Practicum I, III and IV of the Degree in Physiotherapy. The two sessions to be held in the context of the Training will have common objectives:

To favor a facilitating behavior for learning during the application of the EBS.

To provide tools and strategies to the facilitators for the correct functioning of the EBS.

To establish the differences and similarities of the EBS between the subjects Practicum I, III and V, according to the pre-established increasing difficulty.

Dependent variables:

Debriefing for Simulation in Health (EDSS). This scale assesses facilitator behaviors that facilitate learning and change in experiential contexts, through analysis and assessment of six key elements of a debriefing.

Teaching self-efficacy by means of the Teaching Self-Efficacy Scale. The scale perceived efficacy in student and in instructional practices adjustment and perceived efficacy in classroom management.

The dependent variables of the Facilitators will be collected in three moments: 1) before conducting the EBS Training; 2) at the end of the EBS Training, and 3) at the end of the period of simulations in the subjects Practicum I, III and V of the corresponding courses.

Student variables:

Independent variables:

Sociodemographic data: subject (Practicum I, III, V), age, gender, previous work experience in the health field. These variables will be collected at baseline.

Simulation-based education:

As described above, each student in the Practicum I, III and V subjects will carry out a simulation session based on the context of the subject taken.

The simulations are carried out in groups of 5 students who have the same UVic tutor in common who acts as Facilitator during the simulation. Each simulation is applied following the three previously described phases (prebriefing, simulation per se and debriefing) and the progression between the different subjects places more emphasis on these phases.

Practicum I: the prebriefing has more value in order to guarantee the safety and confidence of the group of students. The simulation per se is developed by two volunteer students. The debriefing is shorter, not very demanding with the result of the case, the objectives are investigated, but without going into excessive depth, undervaluing the error and overvaluing the learning of the students.

Practicum III: the representation of the prebriefing and the debriefing is equalized. The simulation per se is developed by a single volunteer student.

Practicum V: increases the demand of the case, so that it is not necessary to carry out such an extensive prebriefing, but all the parts of the briefing are reviewed, highlighting the objectives to be worked on. The debriefing is more demanding, reflective and complete, with a greater burden of transfer to the real clinical space. The simulation per se is developed by only 1 volunteer student.

Dependent variables:

Dependent variables 1, 2 and 3 of the students will be collected prior to the EBS period in the Practicum I, III and V subjects of the corresponding courses and after the completion of the EBS. Dependent variables 4 and 5 will only be collected after the completion of the EBS period of the corresponding subjects.

All the questionnaires that will be used will be self-administered and will be administered in Spanish.

Perceived self-efficacy specific to academic situations. It will be assessed using the Specific Perceived Self-Efficacy of Academic Situations (AEPESA) scale, which is made up of 10 items that aim to measure self-efficacy expectations in specific situations of the educational context in adolescent and university students.

Academic commitment of university students. It will be assessed using the Well-being in the academic context questionnaire or Utrecht Work Engagement Scale (UWES). It includes the following dimensions:

Academic vigor, measures students' energy, resilience, and willingness to invest effort in their studies.

Academic dedication, assesses students' psychological involvement and commitment to their studies.

Academic absorption, measures students' ability to be completely immersed in their studies.

Satisfaction and confidence regarding EBS, using the Student Satisfaction and Self-Confidence in Learning (SCLC) questionnaire.

Students' perception of the best educational practices in simulation, through the questionnaire on educational practices (EPQ-Sp).

In phase 2, qualitative data will be collected through online focus group interviews, once the EBS and evaluation period of the Physiotherapy Degree students has ended.

A researcher, without a relationship of superiority over the students, will contact the selected students via email and invite them to participate in a single FG.

All FGs will have the same structure: 1) presentation and introduction, in which the participants and the facilitator will introduce themselves; 2) group discussion, in which the facilitator will ask questions based on the script in a flexible way; and 3) conclusions and closure. All FGs will be video and voice recorded to ensure that no data is lost and the researcher will note any relevant aspects observed during the discussions.

Data analysis

Phase 1. Quantitative analysis:

For statistical analysis, the computer program "The Statistical Package for the Social Sciences" will be used. To analyze the distribution of data related to the facilitators, the Shapiro-Wilk test (p\> 0.05) will be used, and for student data, the Kolmogorov-Smirnov test (p\> 0.05).

In the case of objectives 1.1. and 1.2., descriptive statistics will be used. In the event that the data follow a normal distribution, parametric tests such as the repeated measures ANOVA analysis of variance will be applied to assess the change over time for the study variables. To assess the change in the study variables in the different periods, the Student T-test of related measures will be applied. The Bonferroni correction will be applied for multiple comparisons. In the event that the data do not follow a normal distribution, non-parametric tests such as Friedmann's ANOVA and the Wilcoxon Signed Rank Test will be applied.

For objective 1.3. a descriptive analysis of the study variables will be carried out.

Phase 2. Qualitative analysis:

The data to be analyzed in this case will be the transcriptions of the FG recordings. First, the voice recordings will be transcribed verbatim. The notes taken during the FG will be incorporated as a "commentary." During the transcription process, the identifying information of the participants will be removed and the data will be coded using numerical codes. After coding the files with the same numerical code for each FG, they will be stored on the UVic-UCC Office 365 server. Once coded, the transcripts will be sent to the participants for their approval. If any participant considers making any changes to the transcripts, the interviewer will repeat the data verification process until obtaining their approval of the transcription. Once approved, the voice and video recording files will be deleted.

The entire qualitative analysis process will be carried out using the Atlas.ti software. In the first phase, all transcripts will be read and re-read to familiarise themselves with the data, and primary themes will be generated. In the second phase, the provisional list of primary themes will be organised into groups of "codes". In the third phase, the codes will be applied across all transcripts for analysis.

Eligibility criteria: The following inclusion and exclusion criteria have been established for the student population:

Inclusion criteria:

1. First enrollment in the Pràcticum I, III, or V courses.
2. Completion of the full SBE session.

Exclusion criteria:

a) Failure to achieve a grade of 5 in any of the evaluative components of the course.

Regarding the inclusion and exclusion criteria established for the facilitators:

Inclusion criteria:

a) Facilitator of simulations in the Pràcticum I, III, or V courses.

Exclusion criteria:

a) Failure to attend both training sessions.

Primary outcomes:
measure: Perceived Self-Efficacy in Academic Situations
timeFrame: Baseline (pre-SBE), 3 months (Post-SBE)
measure: Behavior to Facilitate Student Learning During SBE
timeFrame: Baseline (pre-capacitation), 3 months (pre-SBE), 4 months (post-SBE)
Secondary outcomes:
measure: Academic Engagement of University Students
timeFrame: Baseline (pre-SBE), 3 months (Post-SBE)
measure: Empathy in Health Science Students
timeFrame: Baseline (pre-SBE), 3 months (Post-SBE)
measure: Satisfaction and Confidence Regarding SBE
timeFrame: 3 months (Post-SBE)
measure: Perception of Educational Best Practices in Simulation
timeFrame: 3 months (Post-SBE)
measure: Teaching Self-Efficacy Using the Teaching Self-Efficacy Scale
timeFrame: Baseline (pre-capacitation), 3 months (pre-SBE), 4 months (post-SBE)
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Universidad de Vic - Universidad Central de Cataluña
state: Barcelona
Study officials:
affiliation: UVIC-UCC
name: Mirari Ochandorena Acha, doctor
role: PRINCIPAL_INVESTIGATOR
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