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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05575869
Other study ID # PRONEtection #2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2022
Est. completion date December 23, 2022

Study information

Verified date November 2023
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomised controlled trial is to compare the impact of online educational material versus a classic lecture on the confidence levels, knowledge and knowledge application of final-year nursing students. Participants will be asked to complete a baseline self-efficacy evaluation and a baseline knowledge test which were validated by the 11-member international expert panel previously established. After randomization, the control group will be asked to attend a classic 1-hour lecture at the nursing school about the topic of prone positioning and skin/tissue damage prevention. The experimental group will get access to the PRONEtect educational website containing short simulation videos and other learning materials. Three weeks later the participants will be asked to complete the self-efficacy evaluation and knowledge assessment again, additionally a knowledge application assessment. All the questionnaires will be administered via Qualtrics.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 23, 2022
Est. primary completion date December 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Final year nursing students studying towards their Bachelor in Nursing degree - Chosen topics of critical care nursing as supplementary subject or critical care subjects as part of their course or complex wound management as part of their course. Exclusion Criteria: Nursing students who are not yet in their final year of studies.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
(online) PRONEtect educational material
This is a website containing educational material like short simulation videos on how to turn a patient from supine-to-prone and prone-to-supine positioning, how to protect the skin from incontinence, or before securing endotracheal-/nasogastric tubes, how to reposition the patient to prevent pressure injuries, a full protocol regarding prone positioning etc.
Classic (normal) one hour lesson/lecture
As per normal, a classroom lecture given by the nursing school by one of the nursing school lecturers.

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knowledge assessment (test score) A total sample size of 78 participants (39 in each group, 1:1 allocation ratio) to have at least 80% power to demonstrate non-inferiority of the online package (experimental group) compared to the classical lecture (control group) with respect to the mean change from baseline in knowledge at week 3 at the one-sided 1.25% significance level, when the non-inferiority margin is set at 1 point and when we assume a common standard deviation in both groups of 2.5 points, a true difference between the groups of 1 point in favor of the online package, and a drop-out rate of 20%. 3 weeks
Secondary Confidence levels (survey scores) A total sample size of 78 participants (39 in each group, 1:1 allocation ratio) to have at least 80% power to demonstrate non-inferiority of the online package (experimental group) compared to the classical lecture (control group) with respect to the mean change from baseline in knowledge at week 3 at the one-sided 1.25% significance level, when the non-inferiority margin is set at 1 point and when we assume a common standard deviation in both groups of 2.5 points, a true difference between the groups of 1 point in favor of the online package, and a drop-out rate of 20%. 3 weeks
Secondary Difference between the "Knowledge application" (test score) between the groups Difference between the "Knowledge application" (test score) of 1-2 points between the groups 3 weeks
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