Comparing training of final year Saudi nursing students in advanced heart-focused life support using a remote simulation and a traditional mannequin demonstration

ISRCTN ISRCTN17963963
DOI https://doi.org/10.1186/ISRCTN17963963
Submission date
16/08/2021
Registration date
07/09/2021
Last edited
14/04/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Every year, 17 million individuals die as a result of cardiovascular disease (CVD). This figure is expected to grow to 23.6 million by 2030. Nurses must be well-versed in cardiopulmonary resuscitation (CPR). The World Health Organization and Sigma Theta Tau International have developed worldwide standards for midwives and nurses' first aid training. Previous studies have shown that technology may be utilized to make learning more interesting and valuable.

The aim of this study is to investigate the effectiveness of High Fidelity Simulation (HFS) on final-year undergraduate Saudi nurses’ knowledge, skills performance acquisition, retention, and self-efficacy with regard to Advanced Cardiac Life Support (ACLS) in Saudi Arabia.

Who can participate?
Saudi final year undergraduate nursing students.

What does the study involve?
Participants in this study will be allocated into one of two groups, with an equal chance of being in either group (like tossing a coin). The groups will receive one of two different teaching methods, High Fidelity Simulation (HFS) or a PowerPoint presentation and demonstration on a static mannequin. Both groups be assessed using the knowledge written-exam test, skill performance test using a checklist tool, and self-efficacy evaluation using The Resuscitation Self-efficacy Scale.

A sample of the participants will also be invited to take part in semi-structured interviews about their experience of the training. The participants who did not recieve teaching using High Fidelity Simulation (HFS) will be offered the option of participating in the HFS teaching following the study's conclusion.

What are the possible benefits and risks of participating?
By participating in the study, participants will be able to reflect on their nursing abilities and knowledge. If they successfully complete all parts of the study, the researcher will offer them comments identifying their strengths and shortcomings, which will aid them throughout their learning journey. In addition, participants will gain exposure to a novel teaching technique, such as high-fidelity simulation.

Where is the study run from?
Taif University (Saudi Arabia)

When is the study starting and how long is it expected to run for?
From September 2020 to March 2022

Who is funding the study?
Taif University (Saudi Arabia)

Who is the main contact?
1. Mr Abdullah Alshehri, s1671948@ed.ac.uk
2. Prof Aisha Holloway (Principal supervisor), aisha.holloway@ed.ac.uk

Contact information

Mr Abdullah Alshehri
Scientific

Old Medical School
Elsie Inglis Quadrangle
Teviot Place
The University of Edinburgh
Edinburgh
EH8 9AG
United Kingdom

Phone +44(0)131 651 3969
Email s1671948@ed.ac.uk
Prof Aisha Holloway
Scientific

Room 2m6, School of Health in Social Science
Doorway 6, Old Medical Quad
Teviot Place
The University of Edinburgh
Edinburgh
EH8 9AG
United Kingdom

ORCiD logoORCID ID 0000-0003-3070-3703
Phone +44 (0) 131 651 1525
Email aisha.holloway@ed.ac.uk

Study information

Study designSingle-center single-blinded pilot randomized controlled trial with a qualitative interview substudy
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleFinal year undergraduate Saudi Nursing students’ self-efficacy towards High-Fidelity Simulation and Its relationship with knowledge and skill performance acquisition and retention of Advanced Cardiac Life Support (HFSACLS): a pilot feasibility study
Study acronymHFSACLS
Study objectives1. At three different time periods, the result of final-year undergraduate nursing students will show no statistically significant differences in knowledge acquisition and retention scores (measured by Taif University school of nursing written exam) between those who received the HFS intervention and those who received only a PowerPoint presentation and a demonstration on a static mannequin.
2. The pre and post-test results of final-year undergraduate nursing students will show no statistically significant differences in psychomotor skills performance acquisition and retention scores (measured by the performance evaluation tool, which developed by the school of nursing at Taif University) between those who received the HFS intervention and those who received only a PowerPoint presentation and a demonstration on a static mannequin.
3. The pre and post-test results of the self-efficacy scores (measured by the Resuscitation Self-efficacy Scale) will not be statistically significantly different between the students who received the HFS intervention and those who received only a PowerPoint presentation demonstration on a static mannequin.
Ethics approval(s)1. Approved 20/10/2020, The University of Edinburgh Research Ethics Committee (Medical School, Doorway 6, Teviot Place, Edinburgh, EH8 9AG, UK; +44 (0)131 651 3969; hiss.ethics@ed.ac.uk), ref: NURS055
2. Approved 07/12/2020, Taif University Research Ethics Committee (Airport Main Road, Al Hawiyah, Taif, 2657, Saudi Arabia; +966 (0) 12 727 2020; ethics.committee@tu.edu.sa), ref: 42-016
Health condition(s) or problem(s) studiedAdvanced cardiac life support teaching for nursing students
InterventionParticipants will be randomised at a ratio of approximately 1:1 using computerised Brandon allocation. The intervention group will receive training using high fidelity simulation an innovative teaching method for advanced cardiac life support (ACLS) one day after the knowledge written exam and at 12 weeks follow up. The control group will receive a traditional teaching method for advanced cardiac life support (ACLS) using PowerPoint presentations and demonstrations on a static mannequin one day after the knowledge written exam and at 12 weeks follow up. Both teaching methods will be delivered to students in groups of 4.

A sample of the participants will also be invited to take part in a qualitative study using semi-structured interviews to ask about their experiences of the high fidelity simulation training method. The participants in the control group will be offered the option of participating in the high fidelity simulation teaching following the study's conclusion.
Intervention typeBehavioural
Primary outcome measureSkill performance is measured using the Performance Evaluation tool developed by the nursing school at Taif University at baseline and 3 months
Secondary outcome measures1. Knowledge measured using 20 multiple-choice questions set by The Taif University (nursing school curriculum) at baseline, 1 week, and 3 months
2. Self-efficacy measured using The Resuscitation Self-efficacy Scale at baseline and 3 months
Overall study start date17/09/2020
Completion date31/03/2022

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participantsThe target number was 80 to 100 participants; however, the number was reduced due to the COVID-19 circumstances.
Total final enrolment28
Key inclusion criteria1. Saudi Arabian nursing students in the final year of their undergraduate nursing programme
2. Agree to participate in the study
3. Have not previously studied an Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) course
Key exclusion criteria1. Unwilling to participate in the study
2. Already certified with Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) licences
3. Students bridging their degree to Bachelor of Science in Nursing (BSN) with previous clinical experiences
Date of first enrolment21/10/2020
Date of final enrolment04/02/2022

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

Simulation and Medical Training Centre, Taif University
Medical School
Taif University
Al Hawiyah
Airport Main Road
Taif
26571
Saudi Arabia

Sponsor information

Royal Embassy of Saudi Arabia Cultural Bureau in London, Taif University
University/education

630 Chiswick High Rd
Chiswick
London
W4 5RY
England
United Kingdom

Phone +44 20 3249 7000
Email sacbuk@uk.moe.gov.sa
Website https://uksacb.org

Funders

Funder type

University/education

Taif University
Government organisation / Local government
Alternative name(s)
TU
Location
Saudi Arabia

Results and Publications

Intention to publish date28/02/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe study will be reported in a PhD thesis, and publication will be planned in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Abdullah Alshehri (s1671948@ed.ac.uk, and alshehri.a.a.s@gmail.com). After de-identification, all data acquired on individual participants during the trial will be made available. Consent from participants was obtained for data sharing. The study protocol, statistical analysis plan and analytic code will also be available. Data will become available beginning 9 months after thefollowing the submission of the PhD thesis, receiving of the PhD student's degree, and article's publication, and concluding 36 months afterwards. Proposals should be addressed to the investigator-in-chief. Data requestors must sign a data access agreement in order to receive access. Data will be shared with researchers who submit a proposal that adheres to accepted methodologies to accomplish the objectives outlined in the approved proposal.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 14/04/2023 No No

Additional files

ISRCTN17963963_BasicResults.pdf

Editorial Notes

14/04/2023: A basic results summary has been added.
04/04/2022: The recruitment end date was changed from 01/03/2022 to 04/02/2022.
06/09/2021: Trial’s existence confirmed by School of Health In Social Science of The University of Edinburgh.