Determine the effect of application oral care protocol on oral health status for Children undergoing Mechanical Ventilation.
Design
A quasi-experimental design employee to achieve the aforementioned objectives: (25 mechanically ventilated children) will be assigned to Join the study group (apply oral care protocol). Whereas the rest will be in the control group include (25 mechanically ventilated children, receives usual oral care). The total sample size would be (50 participant).
Settings and conduct
A 50 mechanically ventilated children which ages range from (≥ 6 months) to (18 years) admitted at PICU and ICU at the following hospitals:
1. Medical City Complex Directorate (PICU in Child Welfare Teaching Hospital, ICU, and Iraqi Center for Cardiology in Specialized Surgery Hospital).
2. Baghdad Health Directorate \Al-Karkh (Ibn Al-Bitar Hospital, Central Children's Hospital).
3. Baghdad Health Directorate \Al-Rusafa (Al-Numan Hospital, Ibn Al-Nafis Hospital)
Non-probability purposive sample of (50) children undergoing mechanical ventilation
Participants/Inclusion and exclusion criteria
The inclusion criteria are:
1. Children who orally intubate 2. Age (≥ 6 months -18 years). 3. Conscious and Unconscious children.
The exclusion criteria are:
1. Children who shifted on a tracheostomy tube during the study. 2. Children who haven’t teeth.
3. Children who have teeth or maxillary trauma are excluded. 4. Children whose parents or relatives do not agree to the application of protocol.
Intervention groups
The selected study group must be undergoing to intervention which depend on oral care protocol which perform every (12 hours) for (5 consecutive days).
Main outcome variables
Improvement of oral health status for mechanically ventilated children.
General information
Reason for update
Acronym
OCP
IRCT registration information
IRCT registration number:IRCT20250211064708N1
Registration date:2025-04-13, 1404/01/24
Registration timing:prospective
Last update:2025-04-13, 1404/01/24
Update count:0
Registration date
2025-04-13, 1404/01/24
Registrant information
Name
Ahmed Abdulkadhim Mohammed
Name of organization / entity
University of Baghdad- College of nursing
Country
Iraq
Phone
+964 771 337 2907
Email address
ahmed.abd1204a@conursing.uobaghdad.edu.iq
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-05-01, 1404/02/11
Expected recruitment end date
2025-12-30, 1404/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Application Oral Care Protocol on Oral Health Status for Children Undergoing Mechanical Ventilation
Public title
Application Oral Care Protocol on Oral Health Status for Children undergoing Mechanical Ventilation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children who orally intubated and connect to mechanical ventilation (MV) for (at least 3 to 5 days), and no more than one month.
Age (≥ 6 months -18 years).
Conscious and Unconscious children.
Exclusion criteria:
Children who shifted on a tracheostomy tube during the study.
Children who haven’t teeth.
Children who have teeth or maxillary trauma are excluded.
Children whose parents or relatives do not agree to the application of protocol.
Age
From 6 months old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2025-03-20, 1403/12/30
Ethics committee reference number
36
Health conditions studied
1
Description of health condition studied
Children undergoing mechanical ventilation
ICD-10 code
A69.1
ICD-10 code description
Other Vincent's infections
Primary outcomes
1
Description
Improvement of oral health condition (removal of plaque formation, decrease bacterial colonization, and limit local and systemic effect of poor oral care) for mechanically ventilated children)
Timepoint
The child’s Sociodemographic and clinical characteristics (tool 1) will filled out by the researchers, then the Beck Oral Assessment scale (tool 2) is implement for all included mechanically ventilated children, before and after the intervention (Oral Care Protocol) which perform every (12 hours) for (5 consecutive days).
Method of measurement
Child’s Sociodemographic and Clinical Characteristics, Beck Oral Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Study (Intervention) Group: After identifying the intervention group, their oral health status is assessed using the Beck Oral Assessment scale, then they undergo the oral care protocol which includes the use of these interventions (Toothbrushing, chlorhexidine gauze swab), then reassessing their oral health status using the same scale after each time the interventions apply which are conducted every (12 hours) for (5 consecutive days), to determine the efficacy of the protocol. Control Group: After identifying the Control group, their oral health status is assessed using the Beck Oral Assessment scale, then they receive only routine oral care, then reassessing their oral health status using the same scale after each time routine oral care which are applied every (12 hours) for (5 consecutive days).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
PICU in Child Welfare Teaching Hospital, ICU, and Iraqi Center for Cardiology
Full name of responsible person
Ahmed Abdulkadhim Mohammed
Street address
Akad\ Baghdad
City
Baghdad
Postal code
10045
Phone
+964 771 337 2907
Email
ahmed.abd1204a@conursing.uobaghdad.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor wissam Jabbar Qasim , PhD. Dean
Street address
Bab AL-Muadum Campus
City
Baghdad
Postal code
10001
Phone
+964 770 886 8229
Email
ahmed.abd1204a@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study.
When the data will become available and for how long
Once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission.
From where data/document is obtainable
The author's professional e-mail that will be available.
What processes are involved for a request to access data/document
The author's professional e-mail that will be available.