NCT06624007

Brief Summary

Problem description: Orthopedic surgeries are common in pediatric orthopedics, treating various conditions resulting from developmental, genetic, neoplastic, nutritional, infection, neurological, or physical injuries. The Pediatric Nursing Excellence model helps nurses provide optimal care, improve childcare systems, and deliver high-quality care. It also helps nurses identify trends in specialty nursing excellence. The study aims to evaluate the application of the Pediatric Nursing Excellence Model on nurses' performance regarding the care of children undergoing orthopedic surgeries. Methodology: Randomized Controlled Trial will be conducted using a sample of 100 nurses working in the pediatric inpatient surgical unit of Tanta University Hospital. Three tools will be used for data collection: a knowledge assessment questionnaire, an orthopedic surgeries nurse practice observational checklist, and the Pediatric Nursing Excellence (PNE) model. All study participants will randomly assign to two intervention and control groups (50 each) using a computer-generated table of random numbers. Pediatric Nursing Excellence Model will be applied for the intervention group. The Control group receive routine care. The study participants will be informed about the nature and aim of the study with assuring confidentiality and anonymity. Expected outcome: Nurses who will participate in the pediatric nursing excellence (PNE) model application are expected to have an improvement in their performance regarding care of children undergoing orthopedic surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 21, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

PediatricNursing Excellence ModelNurses Performance

Outcome Measures

Primary Outcomes (1)

  • Nurses performance

    High Level of Knowledge: ≥ 80 % • Using Nurses, knowledge Assessment that will assess nurses, knowledge regarding orthopedic surgeries which included types, causes, complications and diagnostic methods as well as Nurses' knowledge regarding preoperative and post operative nursing care. Satisfactory level practice: ≥ 80% * Using practice observational checklist that includes Nursing care for children on admission: hand washing procedure, vital signs, weight measurement, laboratory sampling, care of intravenous infusion. Preoperative nursing care which includes psychological preparation, parent and child education, informed consent, physical preparation and safety precautions High Level of excellence: ≥ 75 % • Using Pediatrics Nursing Excellence Model (PNE)- model that include collaboration, professionalism, advocacy, ethics, Principles of equity, holistic care and family centered care.

    six months study period

Study Arms (2)

Intervention A

EXPERIMENTAL

They will apply pediatric Nursing Excellence (PNE) model for children having orthopedic surgery

Other: pediatric Nursing Excellence (PNE) model

Control group

NO INTERVENTION

They will provide routine care for children having orthopedic surgery

Interventions

The intervention group will apply pediatric Nursing Excellence (PNE) model included 28 Likert-type questions to assess nurses' general excellence level regarding the care of children undergoing orthopedic surgeries grouped under five main categories including engagement, values, principles, care delivery and continuous improvement.

Intervention A

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nurses with a Diploma or bachelor's degree or higher
  • No present or previous participation in the same study
  • Willing to give written informed consent to participate in the study.

You may not qualify if:

  • present or previous participation in the same study
  • Not Willing to give written informed consent to participate in the study.
  • Missing two sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Department of New Surgical Hospital, and Pediatric Surgical Orthopedic Department - Tanta University Hospital.

Tanta, Gharbia Governorate, 31511, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Models, Biological

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researchers will interview participants, explain the purpose of the study and they will ask them to sign the consent. intervention group will apply Pediatric nursing excellence(PNE) model for children having orthopedic surgery, while the control group will provide routine care only for children having orthopedic surgery. They will randomly assign in two intervention and control groups (50 each) using a computer-generated table of random numbers and they are unaware of which group they have been assigned to as well as the outcome assessor is unaware
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Group A: intervention group: Nurses who will apply Pediatric nursing excellence(PNE) model for children having orthopedic surgery. Group B: Control group: Nurses who will provide routine care only for children having orthopedic surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor- Department of Maternal and Newborn Health Nursing - College of Nursing- Jouf University

Study Record Dates

First Submitted

September 21, 2024

First Posted

October 2, 2024

Study Start

February 1, 2024

Primary Completion

July 30, 2024

Study Completion

September 15, 2024

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

1. No personal identification data will be collected, so the researchers assure participants anonymity. 2. The researchers will collect only the data required to this study. 3. Demographic data of participants will be coded to maintain confidentiality. 4. All submitted data are saved and handled electronically by the researchers only through password-protected files.

Locations