Clinical trial NCT06405399: Design, Implementation and Evaluation of the Guided Observer Role in Clinical Simulation
Official title: Design, Implementation and Evaluation of the Guided Observer Role in Clinical Simulation. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaphylactic Reaction
Keywords: simulation training;
undergraduated students
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to assess the effectiveness of the guided observed role in a simulation learning programme for nursing students in acquiring the competence (knowledge, skills and attitudes) to care for patients affected by anaphylactic situations. This will be achieved by comparing the participants' simulation roles with the guided observed role.

The design was that of an exploratory randomised controlled trial. The variables employed to assess the efficacy of the intervention were competence and its associated attributes. These were measured using a ten-question multiple-choice test to assess knowledge; the simulation performance assessment using the Creighton Simulation Evaluation Instrument to assess skill; the learner's perception of the simulation's effectiveness in meeting their learning needs, through the Simulation Effectiveness Tool Modified (SET-M). Furthermore, the extent to which reflective thinking was achieved during the simulation was evaluated using the Self-Debriefing Reflection Rubric. Additionally, the students' perceptions of their role were assessed through seven open-ended questions.

Detailed description: The study was a prospective, randomised, double-blind controlled trial conducted from October to November 2023 at a Nursing Faculty. The participants were fourth-year Bachelor of Science in Nursing students from a University in the North of Spain. A convenience sample of students from the nursing programme participated in the study. The recommended sample size was 40 participants per group, accounting for a 10% allowance for withdrawals, missing data, and lost follow-up.

Following their registration to participate in the study, 123 students were screened by the researchers to determine their eligibility. Prior to the commencement of the research, the students were informed about the objectives and the project and they signed the informed consent form. Upon arrival at the simulation centre to develop the simulated experience, participants completed the pre-test assessment and were randomly assigned to either the intervention group (57 students) or the control group (56 students) at a 1:1 ratio using a computer-generated assignment. Following the simulation experience, participants completed the post-test assessment and the various tools of the research.

During the study, two participants in the intervention group and one in the control group were excluded due to missing follow-up (refusal to continue in the research), and one student in the control group was removed by statistical analysis. In total, 99 participants were included in the data analysis. The students completed the sociodemographic information (age, gender, and previous experience in simulation experiences with anaphylactic situations) and the data on different variables via the online platform Google Form.

Eligibility criteria: Inclusion Criteria:

* Students enrolled in the 4rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study.

Exclusion Criteria:

* Students who had previously undergone a simulated clinical experience of managing an anaphylactic shock.

Primary outcomes:
measure: Knowledge
timeFrame: two months
measure: Evaluation of the simulated experience: Creighton Simulation Evaluation Instrument (C-SEI)
timeFrame: Two month
Secondary outcomes:
measure: Self-Debriefing Reflection Rubric
timeFrame: Two months
measure: Simulation Effectiveness Tool - Modified (SET-M)
timeFrame: Two months
measure: Open ended questions
timeFrame: Two months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra Pamplona, Navarra, Spain
name: Lizarbe Marta, PhD
role: PRINCIPAL_INVESTIGATOR
References: