Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202205899389032 Date of Approval: 13/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of a hemoglobinopathy nursing program on pediatric student nurses’ awareness and performance
Official scientific title Effect of A Hemoglobinopathy Nursing Program on Pediatric Nursing Students' Performance: A Randomized Control Trial
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 04/02/2017
Actual trial start date 11/02/2017
Anticipated date of last follow up 30/03/2017
Actual Last follow-up date 27/04/2017
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Completed
Publication URL http://srv2.eulc.edu.eg/eulc_v5/Libraries/Thesis/BrowseThesisPages.aspx?fn=PublicDrawThesis&BibID=12584471
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hemoglobinopathy Nursing Program Educational sessions at faculty Lab and teaching hall Feb-April 2017 Experimental Group (n=54) The implementation phase was achieved through sessions within Feb-April 2017 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. 54
Control Group No treatment only assessment Feb-April 2017 No treatment 54 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
pediatric nursing student at the third year, faculty of nursing, Benha University any student had a history of hemoglobinopathies Adult: 19 Year-44 Year 19 Year(s) 23 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/03/2016 Faculty of Nursing Benha University
Ethics Committee Address
Street address City Postal code Country
El- Moror Street, Branch of Farid Nada Street, Benha city, Al kalubia, Egypt Benha 13511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome design and implement a hemoglobinopathy nursing program to improve pediatricnursing students' performance. Feb 2017
Secondary Outcome evaluate the effect of a hemoglobinopathy nursing program on pediatric student nurses' awareness and performance. March April 2017
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Nursing Benha University El- Moror Street, Branch of Farid Nada Street, Benha city, Al kalubia Benha 13511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Loutfy 19 Hoda Abd Alsalam Street, Alsalam, Cairo cairo 11788 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Nursing Benha University El- Moror Street, Branch of Farid Nada Street, Benha city, Al kalubia Benha 13511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Hussein Meabed Schools Street behind Al-Iman Radiology BeniSuef 62511 Egypt
Faten Mahmoud 15 Salah Salem street, Benha city Benha 13511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Loutfy ahmed.loutfy@nursing.bsu.edu.eg +201097358864 19 Hoda Abdalsalam street, alherafeen, alsalam
City Postal code Country Position/Affiliation
Cairo 11788 Egypt Lecturer of Pediatric Nursing at BeniSuef University
Role Name Email Phone Street address
Public Enquiries Faten Mahmoud shafik.faten@yahoo.com +201092652717 15 Salah Salem street, Benha city
City Postal code Country Position/Affiliation
Benha 13511 Egypt Professor of pediatric nursing at Benha University
Role Name Email Phone Street address
Scientific Enquiries Mohammed Meabed m1hmeabed2@yahoo.com +201001310287 Schools Street behind Al-Ayman Radiology
City Postal code Country Position/Affiliation
BeniSuef 11788 Egypt Professor of Pediatrics Faculty of Medicine BeniSuef University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study approval at March 2016, it's my doctorate dissertation I upload Results Reporting and IPD file. Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. ““Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP). For more information or to submit a request, please contact ahmed.loutfy@nursing.bsu.edu.eg”
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://srv2.eulc.edu.eg/eulc_v5/Libraries/Thesis/BrowseThesisPages.aspx?fn=PublicDrawThesis&BibID=12584471 Yes 09/05/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 11/05/2022 Result - 11/05/2022 Result - 11/05/2022 Result - 09/05/2022 Result - 09/05/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://srv1.eulc.edu.eg/eulc_v5/libraries/start.aspx?ScopeID=1.&fn=ApplySearch&criteria1=1.&OrderKey=publishYear+desc&SearchText1=Effect+of+a+hemoglobinopathy+nursing+program+on+pediatric&ItemType=24.2.5.
Changes to trial information