Pressure Ulcer Clinical Trial
Official title:
Evaluate the Impact of Online Educational Material (PRONEtect Educational Hub) on Nursing Students' Knowledge, Confidence Levels, and Application of Knowledge Regarding Skin Protection of the Prone Ventilated Patient - a Randomised Controlled Study
Verified date | November 2023 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03351049 -
An RCT on Support Surfaces for Pressure Ulcer Prevention
|
N/A | |
Completed |
NCT05112068 -
Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
|
||
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Completed |
NCT04540822 -
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
|
N/A | |
Terminated |
NCT05234632 -
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
|
N/A | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
Completed |
NCT01438541 -
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
|
Phase 4 | |
Completed |
NCT00365430 -
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
|
N/A | |
Completed |
NCT04251897 -
Novel Support Surface to Alleviate Pressure Ulcer
|
N/A | |
Completed |
NCT03391310 -
Use of Honey for Pressure Ulcers in Critically Ill Children
|
N/A | |
Recruiting |
NCT04559165 -
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
|
N/A | |
Completed |
NCT05646121 -
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
|
||
Not yet recruiting |
NCT06421454 -
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
|
N/A | |
Terminated |
NCT05547191 -
Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
|
N/A | |
Completed |
NCT05458050 -
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
|
N/A | |
Active, not recruiting |
NCT03048357 -
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
|
N/A | |
Completed |
NCT06025370 -
Pressures During Prone Positions in Healthy Volunteers
|
N/A | |
Recruiting |
NCT05033470 -
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
|
N/A | |
Terminated |
NCT04023981 -
Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
|
N/A |