The effect of implementing an evidence-based multimedia training program on the oral health of patients under mechanical ventilation in the intensive care unit
The effect of the implementation of an evidence-based multimedia training program on the oral health of patients under mechanical ventilation in the intensive care unit
Design
A clinical trial with control and intervention groups of a single blind strain in a non-random way by 110 patients, which is performed on patients and the checklists are completed by nurses.
Settings and conduct
This research will have four main stages, the first stage is the preparation of an oral care educational film and the intervention itself will be carried out in one of the hospitals affiliated to Shahid Beheshti University of Medical Sciences in the ICU department. And the study includes before and after the intervention along with filling the oral care checklist. Blinding is done in separate ICU departments so that the nurses do not interact.
Participants/Inclusion and exclusion criteria
The conditions for entering the study include having at least a valid bachelor's degree in nursing or nursing assistant; having 6 months of work experience in the special care department, and willingness to participate in the research. The condition of non-entry include unwillingness to participate in the study.
Intervention groups
Our intervention, which is performed by nurses, performs oral care with an algorithm designed for intubated patients. The control group also receives routine ward care.
Main outcome variables
Improving oral care in intubated patients hospitalized in the special department
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230810059109N2
Registration date:2024-07-12, 1403/04/22
Registration timing:prospective
Last update:2024-07-12, 1403/04/22
Update count:0
Registration date
2024-07-12, 1403/04/22
Registrant information
Name
kosar pourhasan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3633 3128
Email address
kosarpourhasan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-20, 1403/04/30
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
2024-07-31, 1403/05/10
Actual recruitment end date
2024-09-22, 1403/07/01
Trial completion date
2024-10-22, 1403/08/01
Scientific title
The effect of implementing an evidence-based multimedia training program on the oral health of patients under mechanical ventilation in the intensive care unit
Public title
A review of the effect of implementing an evidence-based multimedia training program on the oral health of patients undergoing mechanical ventilation in the intensive care unit
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a valid bachelor's degree in nursing or nursing assistant
Having 6 months of work experience in the intensive care unit
Willingness to participate in research
Exclusion criteria:
Depressive disorders
The presence of a special disease in the nurse
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
150
Actual sample size reached:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, we have a one-way blinding that includes the study participants (by separating the two ICU sections so that the intervention and control groups do not interact).
Placebo
Not used
Assignment
Parallel
Other design features
Implementation of an evidence-based multimedia training program
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
Seventh floor, SBMUS Building No. 2, Arabi St., Valenjak, Tajrish, Tehran Province
City
Tehran
Province
Tehran
Postal code
1996835919
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.064
Health conditions studied
1
Description of health condition studied
Patients under mechanical ventilation admitted to the special ward
ICD-10 code
J06
ICD-10 code description
Acute upper respiratory infections of multiple and unspecified sites
Primary outcomes
1
Description
The primary outcome can be "the score obtained from the feedback of the oral assessment checklist".
Timepoint
Oral evaluation according to Back's checklist at the beginning of the study (before the start of the intervention) and then 4 weeks later in patients under mechanical ventilation
Method of measurement
Beck Oral Assessment Scale (BOAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Our intervention is to investigate the effect of the implementation of a multimedia training program on the oral care of patients under mechanical ventilation, according to the written algorithm, special mouthwashes should be used twice every 24 hours, and toothbrushes should be used three times every 24 hours along with washing with Normal serum is saline or plain water 4 times a day or using nystatin tablets.
Category
N/A
2
Description
Control group: The control group in this study will only receive routine ward care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
luqman Hospital
Full name of responsible person
Ladan Sedeghi
Street address
Luqman Hospital, South Kargar St.
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 5541 9005
Email
l.sedighi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Vahid Zamanzadeh
Street address
7th floor, Sabums Building No. 2, Arab Street, Valenjak, Tajrish, Tehran Province
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
vzamanzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kosar Pourhasan
Position
Master's student in community health nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, Ayatollah Hashemi Rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
kosarpourhasan@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan Sedighi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, Ayatollah Hashemi Rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
l.sedighi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ladan sedighi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, Ayatollah Hashemi Rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1996835919
Phone
+98 21 2243 9770
Email
l.sedighi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available