Aspiration of Blood in NewbornNCT06685471
Simulation-Based Training Program Effect on Pediatric Nurses Regarding Heel-Prick Screening Test
A study testing Screeing test in people with Aspiration of Blood in Newborn, run by Abeer Abd Elwahed Almowafy at 1 site in Egypt.
Trial summary
This study aimed to assess the impact of simulation-based training on pediatric nurses' knowledge and performance regarding the heel-prick technique used during newborn blood screening tests in select hospitals in Saudi Arabia and Egypt. This study utilized an experimental pre-test and post-test design. Read more about this study
- Who is it for?
- Ages 25 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspiration of Blood in Newborn
- What is being tested?
- Screeing test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 20 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 25 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:The study's inclusion criteria encompassed nurses, regardless of their age, gender, education, experience, part-time status, or administrative responsibilities, who gave their consent to participate. Pediatric nurses in experimental and control groups had recently graduated, worked for less than 6 months, and did not have any training program by simulation-based training for using the Newborn Blood Spot Test Simulator regarding heel-pricks during newborn blood screening tests.
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Exclusion Criteria:The exclusion criteria included nursing experience for more than six months, as well as non-consenting participants.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance Regarding Heel-Prick During Newborn Blood Screening Test
This study aimed to assess the impact of simulation-based training on pediatric nurses' knowledge and performance regarding the heel-prick technique used during newborn blood screening tests in select hospitals in Saudi Arabia and Egypt. This study utilized an experimental pre-test and post-test design. The G*Power Program® Version 3.1.9.4 was employed to determine the necessary sample size to fulfill the study's objectives. The sample consisted of 50 nurses recruited from the Maternity \& Children Hospital Bisha, Al-Namas General Hospital in the Kingdom of Saudi Arabia, and Pediatric Assiut University Hospital in Egypt. The current study's findings indicate that, following simulation-based training, pediatric nurses significantly improved their heel-prick knowledge and performance during the newborn blood screening test. This study provides strong evidence that the simulation-based training program improved nurses' knowledge and performance, and we advise all pediatric healthcare practitioners, physicians, and nurses employed in hospitals and healthcare facilities to undergo advanced simulation-based training. Nursing managers can target public hospitals with low scores by putting systematic methods into place to improve nurses' performance and knowledge in simulation-based training.
Read the detailed description
One of the best ways to impart important skills to trainees is through simulation-based training which is more reliable than the conventional method of doing clinical examinations. It is used in pediatric nursing training to allow nurses to practice and improve their clinical and conversational skills during an actual child encounter. A heel-prick is a complex psychomotor task that requires skill and knowledge on the part of the pediatric nurse who is performing the procedure while applying for the National Newborn Screening Program.
- Conditions
- Aspiration of Blood in Newborn
- Being tested
- Screeing test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screeing testDiagnostic test
Simulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance Regarding Heel-Prick during Newborn Blood Screening Test
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance | Experimental | Simulation-Based Training Program Receives: Diagnostic Test: Screeing test |
| traditional method | No intervention | traditional method program |
What is being measured
The primary outcome is the main question the study is designed to answer.
• pediatric nurses' knowledge in newborn blood screening tests compared to traditional training methods
- Simulation-based training will increase the pediatric nurses' knowledge in newborn blood screening tests compared to traditional training methods.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jun 2023
- Primary completion30 Jul 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration of Blood in NewbornStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abeer Abd Elwahed Almowafy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Abd Elwahed Almowafy, Al-Azhar University
- Investigators
- Abeer Almowafy, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685471
- Sponsor's protocol ID
- UB-RELOC H-06-BH-089)/ 1204.24
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asiri A, Almowafy AA, Moursy SM, Abd-Elhay HA, Ahmed SAK, Abdelrahem AS, Seif MTA, Ahmed FA. Simulation-based training program effect on pediatric nurses' knowledge and performance regarding heel-prick during newborn blood screening test. BMC Nurs. 2025 Jan 29;24(1):110. doi: 10.1186/s12912-024-02657-7.
PubMed 39881378
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance Regarding Heel-Prick During Newborn Blood Screening Test
- ClinicalTrials.gov ID
- NCT06685471
- Acronym / sponsor ID
- UB-RELOC H-06-BH-089)/ 1204.24
- Conditions
- Aspiration of Blood in Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abeer Abd Elwahed AlmowafyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 12 Nov 2024 (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.
This study aimed to assess the impact of simulation-based training on pediatric nurses' knowledge and performance regarding the heel-prick technique used during newborn blood screening tests in select hospitals in Saudi Arabia and Egypt. This study utilized an experimental pre-test and post-test design. The G*Power Program® Version 3.1.9.4 was employed to determine the necessary sample size to fulfill the study's objectives. The sample consisted of 50 nurses recruited from the Maternity \& Children Hospital Bisha, Al-Namas General Hospital in the Kingdom of Saudi Arabia, and Pediatric Assiut University Hospital in Egypt. The current study's findings indicate that, following simulation-based training, pediatric nurses significantly improved their heel-prick knowledge and performance during the newborn blood screening test. This study provides strong evidence that the simulation-based training program improved nurses' knowledge and performance, and we advise all pediatric healthcare practitioners, physicians, and nurses employed in hospitals and healthcare facilities to undergo advanced simulation-based training. Nursing managers can target public hospitals with low scores by putting systematic methods into place to improve nurses' performance and knowledge in simulation-based training.
Detailed description
One of the best ways to impart important skills to trainees is through simulation-based training which is more reliable than the conventional method of doing clinical examinations. It is used in pediatric nursing training to allow nurses to practice and improve their clinical and conversational skills during an actual child encounter. A heel-prick is a complex psychomotor task that requires skill and knowledge on the part of the pediatric nurse who is performing the procedure while applying for the National Newborn Screening Program.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance | Experimental | Diagnostic Test: Screeing testSimulation-Based Training Program |
| traditional method | No intervention | –traditional method program |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Screeing testSimulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance Regarding Heel-Prick during Newborn Blood Screening Test | Diagnostic test | Simulation-Based Training Program Effect on Pediatric Nurses' Knowledge and Performance |
Primary outcome
• pediatric nurses' knowledge in newborn blood screening tests compared to traditional training methods
Time frame: 8 week
• Simulation-based training will increase the pediatric nurses' knowledge in newborn blood screening tests compared to traditional training methods.
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 12 Nov 2024.
- Derived from this study: PubMed 39881378Asiri A, Almowafy AA, Moursy SM, Abd-Elhay HA, Ahmed SAK, Abdelrahem AS, Seif MTA, Ahmed FA. Simulation-based training program effect on pediatric nurses' knowledge and performance regarding heel-prick during newborn blood screening test. BMC Nurs. 2025 Jan 29;24(1):110. doi: 10.1186/s12912-024-02657-7.
- Individual participant dataSharing planned: No
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.
Abeer Almowafy principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screeing test in people with Aspiration of Blood in Newborn, run by Abeer Abd Elwahed Almowafy 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?
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 12 Nov 2024. 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?
• pediatric nurses' knowledge in newborn blood screening tests compared to traditional training methods (time frame: 8 week). 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 NCT06685471, which also lists 1 linked publication.
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 12 Nov 2024; AzTrials last refreshed its copy on 27 Oct 2026.