Determining the effect of designed care program in children with coronary heart disease on the clinical competence of nurses and the severity of the disease in the pediatric intensive care unit of Akbar Mashhad Hospital
Design
The control trial is parallel to the control group. In one group of patients, they receive routine nursing care, and in another group, they receive nursing care in accordance with the care package designed by trained nurses. In each group, 22 patients and a total of 44 patients will be included in the study.
Settings and conduct
In this study, the control group receives routine nursing care based on experience, etc., and the intervention group receives guided care based on a standardized care package according to specific problems in the clinic. Blinding is not performed and the patient The researcher, nurses, physician in charge of the patient's treatment and the statistical analyst know in which group they are. The study will be performed at the PICU of Akbar Hospital in Mashhad.
Participants/Inclusion and exclusion criteria
Children whose RT-PCR test is positive. Age between 0 and 18 years. They are hospitalized in the intensive care unit. Patients who do not want to continue participating in the study or have been discharged before the 6th day of hospitalization have been excluded from the study. Nurses working in the PICU of Akbar Hospital.
Intervention groups
Intervention group: will receive clinical care based on a care package designed with standard nursing diagnoses based on print sources of Linda and Dwayne Jazz nursing diagnoses. Control group: will only receive routine ward care.
Improving the clinical competence of nurses in accordance with the training is the basis for the implementation of the care package.
Main outcome variables
ICU admission, death, and disease severity, clinical qualification
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210703051773N1
Registration date:2022-02-22, 1400/12/03
Registration timing:registered_while_recruiting
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Samaneh Arteshidar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3273 2089
Email address
arteshidars982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of care program training in children with coronary artery on nurses' clinical competence and disease severity
Public title
Evaluation of implementation of care package in children with coronary artery on nurses' clinical competence and disease severity .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Covid disease 19 based on the diagnosis of the treating physician
Admission to the intensive care unit
Satisfaction with participation in the study
Exclusion criteria:
Eluctance to continue participating in the study
They have early discharge
Age
From 1 month old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the effect of education in two groups of nurses working in the ward and children with Covid 19 is measured.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad, Ibn Sina St., towards Imam Reza Hospital, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9771946155
Approval date
2021-08-15, 1400/05/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.045
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Clinical competence of nurses working in pediatric wards
Timepoint
In nurses before and after the workshop.
Method of measurement
Clinical Competency Questionnaire in Nurses
2
Description
Disease severity score
Timepoint
At the time of admission on the third and sixth day of admission to the intensive care unit.
Method of measurement
PRISM III disease severity assessment form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving clinical care based on a care package designed from the day of hospitalization to the sixth day of hospitalization or until the day of discharge. 19 children. In the process of designing this package, first the files of patients with Covid 19 will be studied and analyzed. The list of problems in Covid children will be extracted based on regional data and a diagram for each of the problems in these children. Evidence-based nursing care flowchart will be set. To implement this intervention in the form of care package, first in a 3-day workshop and 3 hours every day, this care package will be taught to nurses working in the care of 19 children. Then, using a check Relevant lists, the process of implementing these cares is followed in the clinic. The intervention group is the patients who will receive the above cares. It should be noted that in the period when we are collecting the care package, the data of the control group will be collected and as soon as the package is prepared and its validity is determined, the care package will be implemented. Those who received care under the above care package (intervention group) will be compared with children with Covid 19 who were not cared for under the above care package (control group).
Category
Rehabilitation
2
Description
Control group: Children with Covid 19 who are not designed according to the care package or the above protocol.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Aramesh Rezaian
Street address
Mashhad, Ibn Sina St., towards Imam Reza Hospital, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9771946155
Phone
+98 56 3272 2089
Email
Arteshidars982@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaian
Street address
Mashhad, Ibn Sina St., towards Imam Reza Hospital, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9771946155
Phone
+98 56 3272 2089
Email
Arteshidars982@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaian
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Ibn Sina St., towards Imam Reza Hospital, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9771946155
Phone
+98 56 3273 2089
Email
Arteshidars982@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaian
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Ibn Sina St., towards Imam Reza Hospital, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9717946155
Phone
+98 56 3272 2089
Email
Arteshidars982@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaian
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Ibn Sina St., towards Imam Reza Hospital, School of Nursing and Midwifery
City
Mashhad
Province
South Khorasan
Postal code
9771946155
Phone
+98 56 3272 2089
Email
Arteshidars982@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
6 months after printing
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
People that the university allows access to.
From where data/document is obtainable
Mashhad University of Medical Sciences. School of Nursing and Midwifery
Ms. Aramesh Rezaeian RezaeianA@mums.ac.ir
Ms. Samaneh Arteshidar Arteshidars982@mums.ac.ir
What processes are involved for a request to access data/document
Contact with the project manager and after coordination with the School of Nursing and Midwifery, data will be provided.