Design, Implementation and Evaluation of the Guided Observer Role in Clinical Simulation

NCT ID: NCT06405399

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2023-11-25

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.

Conditions

Anaphylactic Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Guided observed

Students attended the simulated clinical experience as non-participant observers, but were supported by an observation rubric. Observation took place in situ, within the simulation laboratory itself, in an adjacent video-monitored room.

Group Type: EXPERIMENTAL

Educational intervention. observation guide

Intervention Type: OTHER

An observation checklist based on the Lasater Clinical Judgment Rubric (LCJR) was created and adapted to the simulated clinical experience in order to address the learning outcomes to be achieved by nursing students. This resulted in a list of forty items divided into four main groups: patient safety (8 items), communication and relationship with the patient (7 items), teamwork (7 items) and technical skills (18 items).

Control group: Participant

Students attended the simulated clinical experience directly as participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational intervention. observation guide

An observation checklist based on the Lasater Clinical Judgment Rubric (LCJR) was created and adapted to the simulated clinical experience in order to address the learning outcomes to be achieved by nursing students. This resulted in a list of forty items divided into four main groups: patient safety (8 items), communication and relationship with the patient (7 items), teamwork (7 items) and technical skills (18 items).

Intervention Type: OTHER

Other Intervention Names

Observation guide

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lizarbe Marta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra Pamplona, Navarra, Spain

Locations

University of Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

Simulación

Identifier Type: -

Identifier Source: org_study_id