Condition category
Not Applicable
Date applied
25/05/2019
Date assigned
13/06/2019
Last edited
30/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Nursing students are trained to acquire the capabilities to integrate cognitive, conative, and psychomotor competency skills. Students have fewer opportunities to experience diabetes ketoacidosis, so it is challenging for them to provide patient care. Simulation is one of the innovative teaching and learning practices to provide a realistic experience of diabetes ketoacidosis for student nurses. A wide variety of simulated patient care experiences can be provided in a high-fidelity simulation for critical thinking and self-confidence. With an increasing number of student nurses and the lack of clinical placement opportunities in the Middle East, use of simulation as a teaching-learning nexus pedagogy can help students to develop and master core competencies and achieve high standards of practice.

The aim of the study was to evaluate the effectiveness of simulation teaching intervention for diabetes ketoacidosis in critical care nursing in a public university. The findings may assist to design best educational practices in improving simulation experiences in the nursing program.

Who can participate?
Nursing students at Sultan Qaboos University registered in CCN section A and CCN section B in the Fall 2015 and Spring 2016 can take part.

What does the study involve?
The critical care nursing course developed the high-fidelity simulation presented for diabetes ketoacidosis (HFS-DKA) to integrate cognitive and psychomotor skills of diabetes ketoacidosis that reflected on the learning outcomes. The HFS events and cues that would trigger problem identification, nursing assessment, starting actions/interventions and prioritizing nursing care using a problem-solving approach was developed to run for 30-minutes. Each student was informed with the study information package, signed the confidentiality agreement and consent release form to maintain integrity and concealment of the HFS. The control group participated in standard YouTube videos guided by the teacher portraying cognitive and psychomotor skills for learning about diabetes ketoacidosis on assessment/ physical examination, intravenous fluid, electrolyte and insulin administration, monitoring nutrition and blood glucose.
The study information outlined important information to help you decide whether or not you would like to take part in this research. If you agree, we will ask you to take part in a survey and a potential simulation teaching intervention. We will ask you to share information about yourself and learning. The audio recording of the simulation will be private, and your name will not be used in this study. The tapes of the simulation will only be seen by the research assistant and coordinator. The tapes and surveys will be kept in secure storage following the research. The survey in professional journals will appear for teaching and research purposes without any identification.

What are the possible benefits and risks of participating?
Participation might benefit individuals directly, but the information will help the teaching faculty in the nursing curriculum and program to design simulation intervention.
It is not expected that taking part in this study would cause any harm.

Where is the study run from?
Sultan Qaboos University, Oman.

When is the study starting and how long is it expected to run for?
September 2015 for one month.

Who is funding the study?
Sultan Qaboos University, Oman.

Who is the main contact?
Dr Melba D'Souza,
desouzamelba123@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melba D'Souza

ORCID ID

http://orcid.org/0000-0002-3156-0663

Contact details

College of Nursing
Sultan Qaboos University
Muscat
123
Oman
1-604 751 6672
mdsouza@tru.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IG/SQU/CN/AHCC/15/7/21

Study information

Scientific title

Testing a high-fidelity simulation- diabetes ketoacidosis teaching intervention in critical care nursing: a randomized control trial

Acronym

HFS-DKA

Study hypothesis

A high-fidelity simulation-diabetes ketoacidosis teaching intervention improves satisfaction, self-confidence, critical thinking and critical thinking disposition compared to learning from YouTube in critical care nursing

Ethics approval

Approved 04/06/2015, Sultan Qaboos University institution ethics board (Mr Ramesh Venkatesaperumal, Assistant Dean Undergraduate Studies, Sultan Qaboos University, sageorgelav@gmail.com; 968 - 98137770) ref: IG/SQU/CN/AHCC/15/7/21

Study design

Two arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Other

Patient information sheet

See additional files (ISRCTN12640591_PIS_04June2015.pdf)

Condition

High-fidelity clinical simulation in nursing education

Intervention

The critical care nursing (CCN) course team created the high-fidelity simulation presented for diabetes ketoacidosis (HFS-DKA) scenarios using the high-fidelity simulator Lardeal SIM man. The HFS-DKA scenario was developed to integrate cognitive and psychomotor skills of diabetes ketoacidosis that reflected on the learning outcomes. The HFS events and cues that would trigger problem identification, nursing assessment, starting actions/interventions and prioritizing nursing care using a problem-solving approach was developed to run for 30-minutes. One hour was assigned for pre-briefing using case studies to share conversations. After the simulation activities were completed, a debriefing was performed for one hour by the qualified clinical teachers.

The clinical teacher provided the patient and physician voice. The laboratory technician operated the inputs and parameters of the computerized HFS. The validity of the HFS-DKA scenario was verified by a certified diabetes nurse educator, a registered nurse, a nursing faculty, and a physician, based on a rating scale strongly agree to strongly disagree with open-ended questions. The validity and appropriateness of the high-fidelity simulation scenarios reflected the learning outcomes.

At the baseline/pre-test, the student completed a demographic profile, SSSCL, SDS, EPQ, CCTDI and CCTST surveys.
• Student Satisfaction and Self Confidence in Learning (SSSCL)
• Simulation Design Scale (SDS)
• Educational Practice Questionnaire (EPQ)
• California Critical Thinking Disposition Inventory (CCTDI)
• California Critical Thinking Skill Test (CCTST)

In the simulation group, there were 10 independent groups of 4 students in each group who were exposed to the complete HFS-DKA for 3 hours respectively. Each student group entered the simulation room and was given a script of the case scenario, background and clinical information and vital signs were displayed on the bedside monitor. A total of 30 hours of HFS was performed over 4 days for the simulation group in the third week of the CCN course in the Fall 2015 and Spring 2016 semesters Each student was informed with the study information package, signed the confidentiality agreement and consent release form to maintain integrity and concealment of the HFS. The control group participated in standard YouTube videos (60 minutes) guided by the teacher portraying cognitive and psychomotor skills for learning about diabetes ketoacidosis on assessment/ physical examination, intravenous fluid, electrolyte and insulin administration, monitoring nutrition and blood glucose. The students were not exposed to the HFS and debriefing.

The students who volunteered to participate in the study were confidentially assigned to the simulation or control group using the randomization in a permuted block for a block size of 4 using equal numbers to each treatment. Block 1 randomizes 4 students, with the first two assigned to simulation and the last two assigned to control group. The target sample size is 164 students (82 in Fall 2015 and 82 in Spring 2016) and the investigators enrolled 16 students each week. Each week the students were assigned a simulation and control group on a randomly assigned block specified for the week. Eighty-two students were registered in each CCN course section A (n=41) and B (n=41) in Fall 2015 and 82 students were registered in each course section A (n=41) and B (n=41) in Spring 2016.

The critical care nursing course developed the high-fidelity simulation presented for diabetes ketoacidosis (HFS-DKA) to integrate cognitive and psychomotor skills of diabetes ketoacidosis that reflected on the learning outcomes. The HFS events and cues that would trigger problem identification, nursing assessment, starting actions/interventions and prioritizing nursing care using a problem-solving approach was developed to run for 30-minutes. One hour was assigned for pre-briefing using case studies to share conversations. After the simulation activities were completed, a debriefing was performed for one hour by the qualified clinical teachers. In the simulation group, there were 10 independent groups of 4 students in each group who were exposed to the complete HFS-DKA for 3 hours respectively.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Satisfaction and confidence measured using Student Satisfaction and Self Confidence in Learning (SSSCL) at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).
2. Self-confidence measured using Simulation Design Scale (SDS) at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).
3. Education practice measured using Educational Practice Questionnaire (EPQ) at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).
4. Critical thinking disposition measured using California Critical Thinking Disposition Inventory (CCTDI) at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).
5. Critical thinking skills measured using California Critical Thinking Skill Test (CCTST) at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).

Secondary outcome measures

1. Knowledge score measured by examination at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).
2. Skill performance measured by examination at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).
3. Objective structured clinical examination (OSCE) measured by examination at baseline, pretest (week 4), intervention (weeks 6-10), post-test (week 12).

Overall trial start date

03/06/2015

Overall trial end date

30/05/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Students registered in CCN section A and CCN section B in the Fall 2015 and Spring 2016
2. Willing to participate in the study

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

164

Total final enrolment

164

Participant exclusion criteria

Do not meet inclusion criteria

Recruitment start date

01/09/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Oman

Trial participating centre

Sultan Qaboos University
College of Nursing, Sultan Qaboos University Al-Khoud
Muscat
123
Oman

Sponsor information

Organisation

Sultan Qaboos University

Sponsor details

Sultan Qaboos University
Al-Khoud
Muscat
Muscat
123
Oman
00968-98137770
desouzamelba123@gmail.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Sultan Qaboos University

Alternative name(s)

SQU

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Oman

Results and Publications

Publication and dissemination plan

Research papers, simulation workshop for students, course teachers, and faculty

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality and anonymity from the written consent signed by the participants in the public university, confidentiality agreement form signed with the institutional board ethics and maintaining the identity and the concealment of the participants and the school of nursing.

Intention to publish date

01/09/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2020 results in https://doi.org/10.1016/j.cegh.2020.03.011 (added 30/03/2020)

Publication citations

Additional files

Editorial Notes

30/03/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 27/08/2019: Internal review. 14/06/2019: The participant information sheet has been uploaded as an additional file. 06/06/2019: Trial’s existence confirmed by Sultan Qaboos University