NCT05389891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2017

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

May 12, 2022

Last Update Submit

May 21, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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.

    10 weeks

Study Arms (2)

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.

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.

Interventions

"Hemoglobinopathy Nursing Program" is more informative for "Groupe 1" than "Group 2"

Group 1

Eligibility Criteria

Age19 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pediatric nursing students registered for the academic year 2016/2017

You may not qualify if:

  • Any student had personal or family history of hemoglobinopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Other, 13511, Egypt

Location

MeSH Terms

Conditions

HemoglobinopathiesThalassemiaAnemia, Sickle Cell

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 25, 2022

Study Start

February 27, 2017

Primary Completion

April 26, 2017

Study Completion

May 11, 2017

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

The study approval in March 2016, it's my doctorate dissertation and I will upload Results Reporting and IPD file as per request.

Shared Documents
STUDY PROTOCOL, SAP
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.
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"

Locations