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

NCT06405399 | Completed

• 1 other identifier: Simulación
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaphylactic Reaction

Keywords

simulation training;; undergraduated students

Outcome Measures

Primary Outcomes (2)

• Knowledge

  In order to gauge the comprehension of information pertaining to a case of anaphylactic shock, a questionnaire comprising 10 multiple-choice inquiries, each presenting four possible responses, was devised. This questionnaire encapsulates the primary algorithms delineating the contemporary approach to managing anaphylactic shock, as outlined by the European Resuscitation Council in 2021, alongside delineations of requisite nursing interventions.

  two months

• Evaluation of the simulated experience: Creighton Simulation Evaluation Instrument (C-SEI)

  In order to assess the proficiency development of students allocated to the intervention group (guided observers) and the control group (participants), the Creighton Simulation Evaluation Instrument (CSEI) was employed. The CSEI, translated and validated into Spanish in 2019, comprises 22 dichotomous items divided into four different components: assessment, communication, critical creative, and technical skills. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.839. The exclusion of any one of the questions was not found to significantly enhance the internal consistency of the scale.

  Two month

Secondary Outcomes (3)

• Self-Debriefing Reflection Rubric

  Two months

• Simulation Effectiveness Tool - Modified (SET-M)

  Two months

• Open ended questions

  Two months

Study Arms (2)

Guided observed

EXPERIMENTAL

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.

Other: Educational intervention. observation guide

Control group: Participant

NO INTERVENTION

Students attended the simulated clinical experience directly as participants.

Interventions

Educational intervention. observation guide 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).

Also known as: Observation guide

Guided observed

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31003, Spain

Location

MeSH Terms

Conditions

Anaphylaxis

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lizarbe Marta, PhD

  University of Navarra Pamplona, Navarra, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded in their group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 8, 2024
• Study Start: May 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: November 25, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-04

Locations

ES (1)