Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405399
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-05-06
Brief Title:
Design Implementation and Evaluation of the Guided Observer Role in Clinical Simulation
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Design Implementation and Evaluation of the Guided Observer Role in Clinical Simulation A Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 learners perception of the simulations 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
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 learners perception of the simulations 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None