Pediatric ALLNCT06624007
Applying Pediatric Nursing Excellence Model to Nurses in Orthopedic Surgery Care of Children
A study testing pediatric Nursing Excellence (PNE) model in people with Pediatric ALL and Nurse's Role, run by Jouf University at 1 site in Egypt.
Trial summary
Problem description: Orthopedic surgeries are common in pediatric orthopedics, treating various conditions resulting from developmental, genetic, neoplastic, nutritional, infection, neurological, or physical injuries. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Pediatric ALL, Nurse's Role, Surgery
- What is being tested?
- pediatric Nursing Excellence (PNE) model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 15 Sep 2024
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- present or previous participation in the same study
- Not Willing to give written informed consent to participate in the study.
- Missing two sessions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Orthopedic Department of New Surgical Hospital, and Pediatric Surgical Orthopedic Department - Tanta University Hospital.
Tanta, Gharbia Governorate, 31511
About this study
Official title: Application of Pediatric Nursing Excellence Model on Nurses, Performance Regarding Care of Children Undergoing Orthopedic Surgeries
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.
Read the detailed description
Orthopedic surgeries are more prevalent among children and are the most conclusive approach of treatment in pediatric orthopedics addressing wide range of conditions and deformities resulting from developmental or genetic disorders, neoplastic disorders, nutritional disorders, infection, neurological conditions, or physical injuries that necessitate extensive surgical intrusions to recover musculoskeletal alignment, functional abilities, control pain, and advance the child's quality of life. Pediatric Nursing Excellence (PNE) model assist nurses in providing the optimal care possible to children, their work environments, also to recognize their efforts to enhance childcare through system improvement. Also, the nursing excellence model provide nurses the necessary knowledge and practice to deliver high-quality nursing care. as well to carry out their responsibilities efficiently and to identify the recent trends in specialty nursing excellence.
The present study aims to evaluate application of pediatric nursing excellence model on nurses' performance regarding care of children undergoing orthopedic surgeries
Hypotheses:
Nurses that participate in the pediatric nursing excellence model application are expected to increase their performance when caring for children having orthopedic surgery.
Design A randomized controlled trial with two parallel groups Randomization Participants will be randomly assigned to either the intervention or control group (50 per group) using a computer-generated randomization sequence with block sizes of varying lengths to ensure allocation concealment.
The study will be conducted in the pediatric inpatient surgical unit at Tanta University Hospital which is affiliated to the ministry of higher education and scientific research.
Three tools will be employed to obtain the relevant data to the present study. Tool (I): Nurses, knowledge assessment questionnaire Part (1): Nurses, Socio demographic characteristics: such as age, gender, academic qualifications, years of experience at the surgical unit, and previous training courses regarding care of children undergoing orthopedic surgeries.
Part (2): Nurses, knowledge Assessment This part assessed nurses, knowledge regarding orthopedic surgeries which included types, causes, complications and diagnostic methods.
Part (3) Nurses knowledge regarding preoperative and post operative nursing care. It included preoperative care as (assess general body condition, vital signs, intake and output, measurement of weight, investigations and diagnostic tests), postoperative nursing care as: complications after surgery, precautions to prevent infection, pain management, wound care, intake and output, discharge instructions.
Scoring system: Each item was scored as follows: correct answers scored (2), correct and incomplete scored (1) and the incorrect or do not know answers scored (0).
The nurses' total knowledge was classified as the following:
- ≥ 80% was considered high level of knowledge
- 60-80 was considered moderate level of knowledge
- <60 was considered low level of knowledge Tool (II): Orthopedic surgeries Nurses, practice observational checklist Part I: Nursing care for children on admission: hand washing procedure, vital signs, weight measurement, laboratory sampling, care of intravenous infusion.
Part II: Preoperative nursing care which includes psychological preparation, parent and child education, informed consent, physical preparation and safety precautions.
Part III: post-operative nursing care; immediately post-operative nursing care, Discharge from the recovery room, pain management, post-operative first day nursing care, wound care, discharge instructions for parents and child.
Scoring system: Each step was evaluated as follows.
- Done correctly scored (1 point)
- Not done scored zero
- Total practice scores are transformed into percentages.
- ≥ 80% considered satisfactory practice.
- <80% considered unsatisfactory practice. Tool III: Pediatric nursing excellence (PNE) model, adopted from McDowell et al., (2023). It will be written in an Arabic language and consisted of (15) 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. Each one of these categories had 3 sub items as following: Engagement: [collaboration, professionalism, and professional development], Values [advocacy, ethics, and quality of life], Principles [equity, holistic care and family centered care], Care delivery [care coordination, care planning and health promotion] and Continuous improvement [evidence-based practice, outcomes, and quality standards]. Scoring system for nurses' excellence level: The nurses excellence level was evaluated from 0 to 30 as; low excellence level 0-9, moderate excellence level 10-19, high excellence level 20-30. The questionnaire rating through a 3-point Likert scale, including agree (2), neutral (1), and disagree (0).
Data collection procedure: through three phases:
I-Assessment Phase:
It will be carried out by the researchers for all nurses to assess nurses, sociodemographic characteristics and knowledge about Tool I
- Nurses practice regarding oral care of mechanically ventilated children will be assessed before, immediate and after one month of program implementation using Tool II
- Nurses will be interviewed individually or in group to fill the questionnaire sheet.
II-Implementation Phase:
-The educational intervention will be prepared and conducted in the previously mentioned settings during the morning shift through four sessions.
The sessions will cover the following topics
- The first session: types, causes, complications and diagnostic methods
- The second session: preoperative and post operative nursing care for children undergoing orthopedic surgeries
- The third session: Pediatric excellence model and its intended purposes, components, general application,
- The fourth session: Excellence criteria of nursing care for child safety, and prevention of medication errors. Approaches for promoting nursing excellence identification in the practice area.
- The quality requirements in managing human and material resources including equipment handling and nursing care. Latest trends in health care services affecting nursing care provided for children undergoing orthopedic surgeries
III-Evaluation phase:
Evaluation of pediatric nursing excellence model on nurses, performance regarding care of children undergoing orthopedic surgeries will be done through comparing the pre and posttest. This phase will be done three times before, immediately and one month later.
- Conditions
- Pediatric ALL, Nurse's Role, Surgery
- Being tested
- pediatric Nursing Excellence (PNE) model
- Keywords
- Pediatric, Nursing Excellence Model, Nurses Performance
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric Nursing Excellence (PNE) modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A | Experimental | They will apply pediatric Nursing Excellence (PNE) model for children having orthopedic surgery Receives: Other: pediatric Nursing Excellence (PNE) model |
| Control group | No intervention | They will provide routine care for children having orthopedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Feb 2024
- Primary completion30 Jul 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Elsharkawy, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624007
- Sponsor's protocol ID
- 358-12-2023
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Pediatric Nursing Excellence Model on Nurses, Performance Regarding Care of Children Undergoing Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT06624007
- Acronym / sponsor ID
- 358-12-2023
- Conditions
- Pediatric ALL, Nurse's Role, Surgery
- Keywords
- Pediatric, Nursing Excellence Model, Nurses Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 2 Oct 2024 (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.
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.
Detailed description
Orthopedic surgeries are more prevalent among children and are the most conclusive approach of treatment in pediatric orthopedics addressing wide range of conditions and deformities resulting from developmental or genetic disorders, neoplastic disorders, nutritional disorders, infection, neurological conditions, or physical injuries that necessitate extensive surgical intrusions to recover musculoskeletal alignment, functional abilities, control pain, and advance the child's quality of life. Pediatric Nursing Excellence (PNE) model assist nurses in providing the optimal care possible to children, their work environments, also to recognize their efforts to enhance childcare through system improvement. Also, the nursing excellence model provide nurses the necessary knowledge and practice to deliver high-quality nursing care. as well to carry out their responsibilities efficiently and to identify the recent trends in specialty nursing excellence.
The present study aims to evaluate application of pediatric nursing excellence model on nurses' performance regarding care of children undergoing orthopedic surgeries
Hypotheses:
Nurses that participate in the pediatric nursing excellence model application are expected to increase their performance when caring for children having orthopedic surgery.
Design A randomized controlled trial with two parallel groups Randomization Participants will be randomly assigned to either the intervention or control group (50 per group) using a computer-generated randomization sequence with block sizes of varying lengths to ensure allocation concealment.
The study will be conducted in the pediatric inpatient surgical unit at Tanta University Hospital which is affiliated to the ministry of higher education and scientific research.
Three tools will be employed to obtain the relevant data to the present study. Tool (I): Nurses, knowledge assessment questionnaire Part (1): Nurses, Socio demographic characteristics: such as age, gender, academic qualifications, years of experience at the surgical unit, and previous training courses regarding care of children undergoing orthopedic surgeries.
Part (2): Nurses, knowledge Assessment This part assessed nurses, knowledge regarding orthopedic surgeries which included types, causes, complications and diagnostic methods.
Part (3) Nurses knowledge regarding preoperative and post operative nursing care. It included preoperative care as (assess general body condition, vital signs, intake and output, measurement of weight, investigations and diagnostic tests), postoperative nursing care as: complications after surgery, precautions to prevent infection, pain management, wound care, intake and output, discharge instructions.
Scoring system: Each item was scored as follows: correct answers scored (2), correct and incomplete scored (1) and the incorrect or do not know answers scored (0).
The nurses' total knowledge was classified as the following:
- ≥ 80% was considered high level of knowledge
- 60-80 was considered moderate level of knowledge
- <60 was considered low level of knowledge Tool (II): Orthopedic surgeries Nurses, practice observational checklist Part I: Nursing care for children on admission: hand washing procedure, vital signs, weight measurement, laboratory sampling, care of intravenous infusion.
Part II: Preoperative nursing care which includes psychological preparation, parent and child education, informed consent, physical preparation and safety precautions.
Part III: post-operative nursing care; immediately post-operative nursing care, Discharge from the recovery room, pain management, post-operative first day nursing care, wound care, discharge instructions for parents and child.
Scoring system: Each step was evaluated as follows.
- Done correctly scored (1 point)
- Not done scored zero
- Total practice scores are transformed into percentages.
- ≥ 80% considered satisfactory practice.
- <80% considered unsatisfactory practice. Tool III: Pediatric nursing excellence (PNE) model, adopted from McDowell et al., (2023). It will be written in an Arabic language and consisted of (15) 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. Each one of these categories had 3 sub items as following: Engagement: [collaboration, professionalism, and professional development], Values [advocacy, ethics, and quality of life], Principles [equity, holistic care and family centered care], Care delivery [care coordination, care planning and health promotion] and Continuous improvement [evidence-based practice, outcomes, and quality standards]. Scoring system for nurses' excellence level: The nurses excellence level was evaluated from 0 to 30 as; low excellence level 0-9, moderate excellence level 10-19, high excellence level 20-30. The questionnaire rating through a 3-point Likert scale, including agree (2), neutral (1), and disagree (0).
Data collection procedure: through three phases:
I-Assessment Phase:
It will be carried out by the researchers for all nurses to assess nurses, sociodemographic characteristics and knowledge about Tool I
- Nurses practice regarding oral care of mechanically ventilated children will be assessed before, immediate and after one month of program implementation using Tool II
- Nurses will be interviewed individually or in group to fill the questionnaire sheet.
II-Implementation Phase:
-The educational intervention will be prepared and conducted in the previously mentioned settings during the morning shift through four sessions.
The sessions will cover the following topics
- The first session: types, causes, complications and diagnostic methods
- The second session: preoperative and post operative nursing care for children undergoing orthopedic surgeries
- The third session: Pediatric excellence model and its intended purposes, components, general application,
- The fourth session: Excellence criteria of nursing care for child safety, and prevention of medication errors. Approaches for promoting nursing excellence identification in the practice area.
- The quality requirements in managing human and material resources including equipment handling and nursing care. Latest trends in health care services affecting nursing care provided for children undergoing orthopedic surgeries
III-Evaluation phase:
Evaluation of pediatric nursing excellence model on nurses, performance regarding care of children undergoing orthopedic surgeries will be done through comparing the pre and posttest. This phase will be done three times before, immediately and one month later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention A | Experimental | Other: pediatric Nursing Excellence (PNE) modelThey will apply pediatric Nursing Excellence (PNE) model for children having orthopedic surgery |
| Control group | No intervention | –They will provide routine care for children having orthopedic surgery |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- present or previous participation in the same study
- Not Willing to give written informed consent to participate in the study.
- Missing two sessions
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 |
|---|---|---|
| pediatric Nursing Excellence (PNE) modelThe 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. | Other | Intervention A |
Primary outcome
Nurses performance
Time frame: six months study period
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.
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 2 Oct 2024.
- Individual participant dataSharing planned: No. 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.
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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 pediatric Nursing Excellence (PNE) model in people with Pediatric ALL and Nurse's Role, run by Jouf 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 3 inclusion and 3 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 2 Oct 2024. 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?
Nurses performance (time frame: six months study period). 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 2 Oct 2024.