Back to resultsHemoglobinopathy Nursing Program and Pediatric Nursing Students
Primary Purpose
Hemoglobinopathies, Thalassemia, Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hemoglobinopathy Nursing Program
Sponsored by
About this trial
This is an interventional treatment trial for Hemoglobinopathies
Eligibility Criteria
Inclusion Criteria:
- pediatric nursing students registered for the academic year 2016/2017
Exclusion Criteria:
- Any student had personal or family history of hemoglobinopathies
Sites / Locations
- Benha University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1
Group 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pediatric nursing students' awareness
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05389891
First Posted
May 12, 2022
Last Updated
May 21, 2022
Sponsor
Beni-Suef University
Collaborators
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT05389891
Brief Title
Hemoglobinopathy Nursing Program and Pediatric Nursing Students
Official Title
Effect of a Hemoglobinopathy Nursing Program on Pediatric Student Nurses' Awareness and Performance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
April 26, 2017 (Actual)
Study Completion Date
May 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoglobinopathies, Thalassemia, Sickle Cell Disease, Nurse's Role
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hemoglobinopathy Nursing Program
Intervention Description
"Hemoglobinopathy Nursing Program" is more informative for "Groupe 1" than "Group 2"
Primary Outcome Measure Information:
Title
Pediatric nursing students' awareness
Description
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).
Time Frame
10 weeks
Title
Pediatric nursing students' Attitude
Description
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).
Time Frame
10 weeks
Title
Pediatric nursing students' Practice
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pediatric nursing students registered for the academic year 2016/2017
Exclusion Criteria:
Any student had personal or family history of hemoglobinopathies
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
Other
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study approval in March 2016, it's my doctorate dissertation and I will upload Results Reporting and IPD file as per request.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
""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"
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Hemoglobinopathy Nursing Program and Pediatric Nursing Students
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