Evaluation of the effect of a care program on the frequency of occurrence and progression of impaired skin integrity in one-month to six-year-old children following an open-heart surgery
Determination and comparison of the effect of a care program on the frequency of occurrence and progression of impaired skin integrity in children following an open-heart surgery
Design
A single-blinding clinical trial, with the parallel groups
Settings and conduct
In this study, 80 children who are candidates for open-heart surgery will be included in the study and will be randomly divided into two groups. In one group, they will receive only routine nursing care, and in the other group, in addition to this care, they will receive care based on a care program taught to nurses. Then the incidence of bedsores and its severity will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included children 1 month to 6 years old who are candidates for open-heart surgery, no wounds in areas under pressure, and parental consent to participate in the study. Exclusion criteria are a history of skin disease and any allergies; the history of food and drug allergies, hemodynamic instability, and suffering from respiratory distress syndrome.
Intervention groups
In this study, children in the control group will receive only routine nursing care to prevent bedsores. However, children in the intervention group, in addition to routine treatments, are cared for according to the care program taught to nurses.
Main outcome variables
Braden Q Scale score, PUSH score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N12
Registration date:2020-11-11, 1399/08/21
Registration timing:retrospective
Last update:2020-11-11, 1399/08/21
Update count:0
Registration date
2020-11-11, 1399/08/21
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-06-22, 1398/04/01
Scientific title
Evaluation of the effect of a care program on the frequency of occurrence and progression of impaired skin integrity in one-month to six-year-old children following an open-heart surgery
Public title
Evaluation of the effect of a care program on the progression of impaired skin integrity following an open-heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children who are candidates for open-heart surgery
No wounds in the area under pressure of the body
Parents' consent for the child's participation in the study
Age range 1 month to 6 years
Exclusion criteria:
History of skin disease
History of allergies
History of food and drug allergies
Hemodynamic instability
Respiratory Distress Syndrome
Age
From 1 month old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, because in the control group only routine nursing care is provided for the child and in the other group, in addition to routine care, care in accordance with the care program taught to nurses will be performed, so the intervention is performed by awareness. But the child will not be aware of group therapy due to a lack of knowledge about the types of care, and the assessor who comes to collect information about the child in the next follow-up will not be aware of the intervention of the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Azadi Square.
City
Isfaha
Province
Isfehan
Postal code
8174673461
Approval date
2019-07-09, 1398/04/18
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.227
Health conditions studied
1
Description of health condition studied
congenital heart disease
ICD-10 code
Q24.9
ICD-10 code description
Congenital malformation of heart, unspecified
Primary outcomes
1
Description
PUSH score
Timepoint
The first day and the last day of the intervention
Method of measurement
Pressure Ulcer Scale for Healing (PUSH)
2
Description
Braden Q Scale score
Timepoint
The first day and the last day of the intervention
Method of measurement
Braden Q Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In the control group, training is not given to nurses and children are subjected to routine (daily) interventions by nurses, including position change, moisture management and nutrition. Also, skin protection products are used systematically according to the surgeon in order to prevent and treat skin injuries.
Category
N/A
2
Description
Intervention group: In the intervention group, child care in the operating room was such that the cotton would be placed on pressure points such as the sacrum, iliac bone, elbow, and back of the child's head to prevent the pressure. Trained by an anesthesiologist every hour during head surgery; The position will be changed while maintaining safe conditions. After surgery, the position will be changed every two hours in bed to prevent abrasion of the scalp and the whole body of children, due to the stability of vital signs. Using a pillow or glove full of water under the heel and small pillows behind the head and between the legs will remove and reduce the amount of pressure. Care and prevention measures will be used using skin protection products such as sprays, foam dressings, and gels.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Ahmadreza Yazdannik
Street address
2nd Moshtagh Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Yazdannik@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadreza Yazdannik
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nursery
Street address
Department of Critical Care Nursing, Chamran Hospital
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Yazdannik@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmadreza Yazdannik
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Nursery
Street address
Department of Critical Care Nursing, Chamran Hospital
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Yazdannik@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Malekpour
Position
Nurse
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Department of Critical Care Nursing, Chamran Hospital
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
Malekpour9880@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD