HemoglobinopathiesNCT05389891
Hemoglobinopathy Nursing Program and Pediatric Nursing Students
A study testing Hemoglobinopathy Nursing Program in people with Hemoglobinopathies and Thalassemia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Hemoglobinopathies are the most common life threatening, monogenic disorders in the world. The most common causes of hemoglobinopathies are sickle cell disease and thalassemia. Aim: This study aimed to evaluate the effect of a hemoglobinopathy nursing program on pediatric nursing students' performance. Read more about this study
- Who is it for?
- Ages 19 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemoglobinopathies, Thalassemia, Sickle Cell Disease
- What is being tested?
- Hemoglobinopathy Nursing Program
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2017to 11 May 2017
- 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 19 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- pediatric nursing students registered for the academic year 2016/2017
Who cannot join
- Any student had personal or family history of hemoglobinopathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Hemoglobinopathy Nursing Program on Pediatric Student Nurses' Awareness and Performance
Hemoglobinopathies are the most common life threatening, monogenic disorders in the world. The most common causes of hemoglobinopathies are sickle cell disease and thalassemia. Aim: This study aimed to evaluate the effect of a hemoglobinopathy nursing program on pediatric nursing students' performance.
- Conditions
- Hemoglobinopathies, Thalassemia, Sickle Cell Disease, Nurse's Role
- Being tested
- Hemoglobinopathy Nursing Program
- Medical subject headings
- Hemoglobinopathies, Thalassemia, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobinopathy Nursing ProgramOther
"Hemoglobinopathy Nursing Program" is more informative for "Groupe 1" than "Group 2"
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Experimental Group (n=54) The implementation phase was achieved through sessions within Feb-April2017 second semester of the academic year 2016/2017.Each session started by the objectives of the new session and summary of previous one. Motivation and reinforcement during session were used to enhance participation and sharing in this study. The researcher did the explanation of the questionnaire sheet to the pediatric student nurses to assess their awareness and attitude toward hemoglobinopathies. The researcher observed the pediatric student nurses 'practice during applying blood transfusion, subcutaneous medication administration, and oral medication administration using the observational checklist at faculty laboratory. Receives: Other: Hemoglobinopathy Nursing Program |
| Group 2 | No intervention | Control Group (n=54) The researcher did the explanation of the questionnaire sheet to the pediatric student nurses to assess their awareness and attitude toward hemoglobinopathies. The researcher observed the pediatric student nurses 'practice during applying blood transfusion, subcutaneous medication administration, and oral medication administration using the observational checklist at faculty laboratory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric nursing students' awareness
Measure Students' awareness through:
- Personal Data and PNSs' Awareness Questionnaire
-sixty (60) questions. A score of (one) for correct answers, and (zero) for the wrong answers. The total scores ranged from (0-60 mark).
Measured: 10 weeks
Pediatric nursing students' Attitude
Pediatric nursing students' Attitude Scale
- nine (9) questions. A five-point Likert scale by give a score of (four) for Strongly Agree, (three) for Agree, (two) for Undecided, (one) for Disagree and (zero) for Strongly Disagree. The total score ranged from (0-36 mark).
Measured: 10 weeks
Pediatric nursing students' Practice
Observational Checklists - forty (40) items. A score of (two) for completely done, (one) for incompletely done and (zero) for not done. The total score ranged from (0-80 mark), scores less than 60% were considered incompetent practice.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start27 Feb 2017
- Primary completion26 Apr 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoglobinopathiesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Ahmed Loutfy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389891
- Sponsor's protocol ID
- PediaMarch201601
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study approval in March 2016, it's my doctorate dissertation and I will upload Results Reporting and IPD file as per request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Hemoglobinopathy Nursing Program on Pediatric Student Nurses' Awareness and Performance
- ClinicalTrials.gov ID
- NCT05389891
- Acronym / sponsor ID
- PediaMarch201601
- Conditions
- Hemoglobinopathies, Thalassemia, Sickle Cell Disease, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 25 May 2022 (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.
Hemoglobinopathies are the most common life threatening, monogenic disorders in the world. The most common causes of hemoglobinopathies are sickle cell disease and thalassemia. Aim: This study aimed to evaluate the effect of a hemoglobinopathy nursing program on pediatric nursing students' performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Hemoglobinopathy Nursing ProgramExperimental Group (n=54) The implementation phase was achieved through sessions within Feb-April2017 second semester of the academic year 2016/2017.Each session started by the objectives of the new session and summary of previous one. Motivation and reinforcement during session were used to enhance participation and sharing in this study. The researcher did the explanation of the questionnaire sheet to the pediatric student nurses to assess their awareness and attitude toward hemoglobinopathies. The researcher observed the pediatric student nurses 'practice during applying blood transfusion, subcutaneous medication administration, and oral medication administration using the observational checklist at faculty laboratory. |
| Group 2 | No intervention | –Control Group (n=54) The researcher did the explanation of the questionnaire sheet to the pediatric student nurses to assess their awareness and attitude toward hemoglobinopathies. The researcher observed the pediatric student nurses 'practice during applying blood transfusion, subcutaneous medication administration, and oral medication administration using the observational checklist at faculty laboratory. |
Who may qualify
- Ages
- 19 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pediatric nursing students registered for the academic year 2016/2017
Key exclusion criteria (1 listed)
- Any student had personal or family history of hemoglobinopathies
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 |
|---|---|---|
| Hemoglobinopathy Nursing Program"Hemoglobinopathy Nursing Program" is more informative for "Groupe 1" than "Group 2" | Other | Group 1 |
Primary outcome
Pediatric nursing students' awareness
Time frame: 10 weeks
Measure Students' awareness through: 01. Personal Data and PNSs' Awareness Questionnaire -sixty (60) questions. A score of (one) for correct answers, and (zero) for the wrong answers. The total scores ranged from (0-60 mark).
Pediatric nursing students' Attitude
Time frame: 10 weeks
Pediatric nursing students' Attitude Scale - nine (9) questions. A five-point Likert scale by give a score of (four) for Strongly Agree, (three) for Agree, (two) for Undecided, (one) for Disagree and (zero) for Strongly Disagree. The total score ranged from (0-36 mark).
Pediatric nursing students' Practice
Time frame: 10 weeks
Observational Checklists - forty (40) items. A score of (two) for completely done, (one) for incompletely done and (zero) for not done. The total score ranged from (0-80 mark), scores less than 60% were considered incompetent practice.
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 25 May 2022.
- Individual participant dataSharing planned: Yes. The study approval in March 2016, it's my doctorate dissertation and I will upload Results Reporting and IPD file as per request.
Related trials for Hemoglobinopathies
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A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Sickle Cell Disease
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Hydroxyurea Optimisation in Sickle Cell Disease
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Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
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A Long-term Follow-up Study in Participants Who Received CS-101
Beta-Thalassemia
Active, not recruitingPhase 2/3
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
Sickle Cell Disease
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 Hemoglobinopathy Nursing Program in people with Hemoglobinopathies and Thalassemia, run by Beni-Suef 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 25 May 2022. 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 nursing students' awareness (time frame: 10 weeks). 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?
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 25 May 2022.