The effectiveness of herbal mouthwash containing Trachyspermum ammi essential oil compared to chlorhexidine on oral state in patients hospitalized in intensive care unit
Comparison of herbal mouthwash containing zenian essential oil with chlorhexidine on oral condition in patients hospitalized in intensive care units.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 and 3 on 98 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Shahid Beheshti and Hazrat Amirul Mominin hospitals in Qom city
Participants/Inclusion and exclusion criteria
1- The patient has a tracheal tube through the mouth during the study.
2- The age range of the patient is 18-65 years.
3- Absence of pregnancy
4- Not mentioning the history of allergy to herbal medicinal substances
5- Not using artificial teeth
6- Not having a specific mouth lesion
7- Absence of any obvious damage by endotracheal intubation or any other physical damage
7- Not taking antibiotics before being admitted to the intensive care unit
8- Less than 12 hours have passed since the patient was admitted to the intensive care unit.
9- Not having an immune deficiency disease (hepatitis or AIDS)
Intervention groups
This study is a double-blind randomized clinical trial that will compare the effectiveness of two mouthwash solutions (Zenian and Chlorhexidine) on the oral condition of intubated patients hospitalized in ICU. In this study, 98 intubated patients admitted to the special care departments of Shahid Beheshti and Hazrat Amirul Mominin hospitals in Qom city will be selected by purposive sampling method and will be selected randomly.
The effectiveness of herbal mouthwash containing Trachyspermum ammi essential oil compared to chlorhexidine on oral state in patients hospitalized in intensive care unit
Public title
Effect of herbal mouthwash containing Trachyspermum ammi essential oil on oral state in patients hospitalized in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1-The patient should have a tracheal tube through the mouth during the study.
2- The age range of the patient should be 18-65 years.
3- Absence of pregnancy
4- Not mentioning the history of allergy to herbal medicinal substances
5- Not using artificial teeth
6- Not having a specific lesion around the mouth
7- Absence of any obvious damage by endotracheal intubation or any other physical damage
8- Not taking antibiotics before being admitted to the intensive care unit
9- Less than 12 hours have passed since the patient was admitted to the intensive care unit.
10- Not having an immune deficiency disease
Exclusion criteria:
Death of the patient before completing the study
Patient transfer from ICU
Identification of any damage caused by tracheal tube or any other factor
Unwillingness to continue cooperation
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, to randomly allocate patients to the intervention and control groups, the online software randomizer.org will be used. First, using the "List Randomizer" feature, numbers 1 to 98 will be randomly generated. The first 49 numbers will be assigned to the intervention group, and the next 49 numbers to the control group.
During the study implementation, 98 sealed envelopes, each containing one of the numbers from 1 to 98, will be prepared. These envelopes will be presented to the participants, and based on the number drawn from the envelope, the participant will be allocated to either the intervention or control group according to the list generated by the software
Blinding (investigator's opinion)
Double blinded
Blinding description
Chlorhexidine mouthwash and herbal mouthwash containing Trachyspermum ammi essential oil are stored in similar containers and a code is inserted on each container.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Qom University of Medical Sciences
Before the study and 4 days after the intervention
Method of measurement
Beck Oral Assessment Scale
2
Description
Oral hygiene state
Timepoint
Before the study and 4 days after the intervention
Method of measurement
Mucosal Plaque Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal mouthwash will be prepared using glycerin (15 ml), ethanol (2 ml), propylene glycol (2 ml), essential oil (0.25 ml) and deionized water up to 100 ml to evaluate the stability in use. From the herbal product, its chemical stability will be calculated according to the amount of thymol in the mouthwash using GC. Mouthwash will be made in Shahid Beheshti University of Medical Sciences.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti and Hazrat AmiralMomenin hospitals in Qom
Full name of responsible person
a
Street address
Mofid Square, the beginning of Shahid Karimi Blvd. (Foundation), first branch, Andisheh dormitory complex.
Student Research Committee, Qom University of Medical Sciences, Qom, IRAN
Latest degree
A Level or less
Other areas of specialty/work
Infectious diseases
Street address
Mofid Square, the beginning of Shahid Karimi Blvd. (Foundation), first branch, Andisheh dormitory complex
City
Qom
Province
Ghoum
Postal code
3713174744
Phone
+98 992 139 6857
Email
mashabani1999@gmail.com
Sharing plan
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as the information related to the main outcome or the like, can be shared.
When the data will become available and for how long
The access period begins after the results are published.
To whom data/document is available
Researchers and managers
Under which criteria data/document could be used
In case of proof of legal and practical use of the data
From where data/document is obtainable
Mohammadamin Shabani, mashabani1999@gmail.com
What processes are involved for a request to access data/document
First, the applicant should introduce himself and the reasons for the need and motivation to access the data, and then his request will be reviewed and, if necessary, additional information will be requested from the applicant.