Ventilator Associated PneumoniaNCT06090019
Ventilator Associated Pneumonia Care Bundle Prevention on Internship Students' Knowledge and Clinical Performance
A study testing Routine PICU nursing care for children on mechanical ventilator. and Self-instructional module for VAP care bundle prevention in people with Ventilator Associated Pneumonia, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to determine the effect of a self-instructional module regarding ventilator-associated pneumonia care bundle prevention on internship students' knowledge and clinical performance in pediatric intensive care unit.The hypotheses of this study were as follows: 1. Read more about this study
- Who is it for?
- Ages Up to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Routine PICU nursing care for children on mechanical ventilator. and Self-instructional module for VAP care bundle prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Nursing intern students at Faculty of Nursing, Alexandria university, Egypt.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Self-Instructional Module Regarding Ventilator Associated Pneumonia Care Bundle Prevention on Internship Students' Knowledge and Clinical Performance in Pediatric Intensive Care Unit
The goal of this clinical trial is to determine the effect of a self-instructional module regarding ventilator-associated pneumonia care bundle prevention on internship students' knowledge and clinical performance in pediatric intensive care unit.The hypotheses of this study were as follows:
- Internship students who are taught by VAP care bundle prevention self-instructional module exhibit higher scores in knowledge test about VAP care bundle prevention than those who are not.
- Internship students who are taught by VAP care bundle prevention self-instructional module exhibit higher scores in performing the VAP care bundle prevention procedure than those who are not.
- Internship students who are taught by VAP care bundle prevention self-instructional module exhibit more positive feedback about it than those who are not.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Routine PICU nursing care for children on mechanical ventilator., Self-instructional module for VAP care bundle prevention
- Keywords
- Self-Instructional Module, Ventilator Associated Pneumonia, Care Bundle Prevention, Internship Students, Knowledge, Clinical Performance, Pediatric Intensive Care Unit
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine PICU nursing care for children on mechanical ventilator.Behavioural
Nursing interns students learned the routine PICU nursing care for the children on mechanical ventilator.
Self-instructional module for VAP care bundle preventionBehavioural
Nursing interns students learned about VAP care bundle prevention self-instructional module through assessment, preparation, implementation and evaluation phases.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Nursing interns students learned the routine nursing care of children on mechanically ventilation to prevent VAP by PICU nurses staff. Receives: Behavioral: Routine PICU nursing care for children on mechanical ventilator. |
| Study group | Experimental | Nursing interns students received comprehensive education about VAP care bundle prevention by self-instructional module through the researchers. Receives: Behavioral: Self-instructional module for VAP care bundle prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing Interns' Knowledge
total score ranged from 0 to 30 distributed as follows: Low knowledge level <60% of the total score, Moderate knowledge level from 60% to <75% of the total score, High knowledge level ≥75% of the total score.
Measured: Before data collection, immediately after and after three months of the clinical experience
Nursing Interns' performance
Total score ranged from 16 to 32 and distributed as follows:
Iow performance <60% of the total score, Moderate performance ranging from 60% to <75% of the total score, High performance for the score ≥75% of the total score.
Measured: Before data collection, immediately after and after three months of the clinical experience
Self-Instructional Module Feedback
It consists of 10 statements with 4 points Likert scale ranging from strongly disagree (1) to strongly agree (4). The higher score, the more positive feedback.
Measured: immediately after VAP care bundle prevention self-instructional module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090019
- Sponsor's protocol ID
- VAP
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abou Zed, S., & Mohammed, A. (2019). Impact of nursing guidelines on nurses' knowledge and performance regarding to prevention of ventilator-associated pneumonia in neonates. Journal of Nursing Education and Practice, 9(10), 1-14.
Ali, S., & Elsayed, E. (2021). Effectiveness of self-instructional module on nurses' performance regarding caring of patient with acute respiratory distress during Covid-19 outbreaks. International Egyptian Journal of Nursing Sciences and Research, 2(2), 378-396. DOI: 10.21608/ejnsr.106256.1123.
Antalova N, Klucka J, Rihova M, Polackova S, Pokorna A, Stourac P. Ventilator-Associated Pneumonia Prevention in Pediatric Patients: Narrative Review. Children (Basel). 2022 Oct 9;9(10):1540. doi: 10.3390/children9101540.
PubMed 36291475Benito, S., Bantulo, S., Haudar, F. (2022). Effectiveness of Self Learning Modules in Teaching Mathematcs. Journal of Recent Research in Thesis and Dissertation (IJRRTD) Vol. 3(1), pp: (33-45)DOI: https://doi.org/10.5281/zenodo.6497186 Available at: www.paperpublications.org
Dsilva, F., Mathew, S., & Gincy, J. (2022). Effectiveness of a self-instructional module on knowledge and observed practices of nurses with regard to prevention of central line-associated blood stream infection. A Before-After Intervention Study Journal of Health Management, 24(2), 233-239,
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Instructional Module Regarding Ventilator Associated Pneumonia Care Bundle Prevention on Internship Students' Knowledge and Clinical Performance in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06090019
- Acronym / sponsor ID
- VAP
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Self-Instructional Module, Ventilator Associated Pneumonia, Care Bundle Prevention, Internship Students, Knowledge, Clinical Performance, Pediatric Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the effect of a self-instructional module regarding ventilator-associated pneumonia care bundle prevention on internship students' knowledge and clinical performance in pediatric intensive care unit.The hypotheses of this study were as follows:
- Internship students who are taught by VAP care bundle prevention self-instructional module exhibit higher scores in knowledge test about VAP care bundle prevention than those who are not.
- Internship students who are taught by VAP care bundle prevention self-instructional module exhibit higher scores in performing the VAP care bundle prevention procedure than those who are not.
- Internship students who are taught by VAP care bundle prevention self-instructional module exhibit more positive feedback about it than those who are not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Behavioral: Routine PICU nursing care for children on mechanical ventilator.Nursing interns students learned the routine nursing care of children on mechanically ventilation to prevent VAP by PICU nurses staff. |
| Study group | Experimental | Behavioral: Self-instructional module for VAP care bundle preventionNursing interns students received comprehensive education about VAP care bundle prevention by self-instructional module through the researchers. |
Who may qualify
- Ages
- Up to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Nursing intern students at Faculty of Nursing, Alexandria university, Egypt.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine PICU nursing care for children on mechanical ventilator.Nursing interns students learned the routine PICU nursing care for the children on mechanical ventilator. | Behavioural | Control group |
| Self-instructional module for VAP care bundle preventionNursing interns students learned about VAP care bundle prevention self-instructional module through assessment, preparation, implementation and evaluation phases. | Behavioural | Study group |
Primary outcome
Nursing Interns' Knowledge
Time frame: Before data collection, immediately after and after three months of the clinical experience
total score ranged from 0 to 30 distributed as follows: Low knowledge level <60% of the total score, Moderate knowledge level from 60% to <75% of the total score, High knowledge level ≥75% of the total score.
Nursing Interns' performance
Time frame: Before data collection, immediately after and after three months of the clinical experience
Total score ranged from 16 to 32 and distributed as follows: Iow performance <60% of the total score, Moderate performance ranging from 60% to <75% of the total score, High performance for the score ≥75% of the total score.
Self-Instructional Module Feedback
Time frame: immediately after VAP care bundle prevention self-instructional module
It consists of 10 statements with 4 points Likert scale ranging from strongly disagree (1) to strongly agree (4). The higher score, the more positive feedback.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- BackgroundAbou Zed, S., & Mohammed, A. (2019). Impact of nursing guidelines on nurses' knowledge and performance regarding to prevention of ventilator-associated pneumonia in neonates. Journal of Nursing Education and Practice, 9(10), 1-14.
- BackgroundAli, S., & Elsayed, E. (2021). Effectiveness of self-instructional module on nurses' performance regarding caring of patient with acute respiratory distress during Covid-19 outbreaks. International Egyptian Journal of Nursing Sciences and Research, 2(2), 378-396. DOI: 10.21608/ejnsr.106256.1123.
- Background: PubMed 36291475Antalova N, Klucka J, Rihova M, Polackova S, Pokorna A, Stourac P. Ventilator-Associated Pneumonia Prevention in Pediatric Patients: Narrative Review. Children (Basel). 2022 Oct 9;9(10):1540. doi: 10.3390/children9101540.
- BackgroundBenito, S., Bantulo, S., Haudar, F. (2022). Effectiveness of Self Learning Modules in Teaching Mathematcs. Journal of Recent Research in Thesis and Dissertation (IJRRTD) Vol. 3(1), pp: (33-45)DOI: https://doi.org/10.5281/zenodo.6497186 Available at: www.paperpublications.org
- BackgroundDsilva, F., Mathew, S., & Gincy, J. (2022). Effectiveness of a self-instructional module on knowledge and observed practices of nurses with regard to prevention of central line-associated blood stream infection. A Before-After Intervention Study Journal of Health Management, 24(2), 233-239,
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine PICU nursing care for children on mechanical ventilator. and Self-instructional module for VAP care bundle prevention in people with Ventilator Associated Pneumonia, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nursing Interns' Knowledge (time frame: Before data collection, immediately after and after three months of the clinical experience). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090019, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.