Protocol summary

Study aim
Determining the effect of chewing gum on head and face edema of burn patients
Design
The research will be a double-blind clinical trial, with parallel and randomized groups, according to the third phase, on 64 patients (32 people in each group) with burns using random allocation according to permutation blocks of 4. The duration of the intervention is considered to be 4 weeks, and the outcome variables will be measured before and after the end of the intervention.
Settings and conduct
The study's site will be the burn department of Imam Khomeini (RA) hospital in Ilam city, where the samples will receive the intervention on the second day of hospitalization
Participants/Inclusion and exclusion criteria
Entry criteria: full consciousness, 24 hours have passed since admission to the ward, second and third degree burns on the head, face and neck, burn percentage less than 50%, having one to three molar teeth on both sides, not consuming food from the street Mouth Exclusion criteria: unwillingness to participate in the study, existence or history of addiction, electric burn, need for surgery and grafting in the head and neck burn site, use of various diuretic drugs
Intervention groups
From the second day of hospitalization, from 9:00 AM to 9:00 PM, every three hours for 20 minutes, the intervention group chews 14 grams of Orbit mint gum for 4 times over a period of 3 days. do not receive All subjects participating in the study will receive head and neck elevation as per the routine.
Main outcome variables
Burn edema

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211110053030N4
Registration date: 2024-07-28, 1403/05/07
Registration timing: registered_while_recruiting

Last update: 2024-07-28, 1403/05/07
Update count: 0
Registration date
2024-07-28, 1403/05/07
Registrant information
Name
Alireza Vasiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7091
Email address
rezawest10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-08, 1403/04/18
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of chewing gum on head and face edema of burn patients
Public title
Investigating the effect of chewing gum on head and face edema of burn patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A score of 13 or higher on the Glasgow Coma Scale 24 hours have passed since admission to the burn ward Second and third degree burns on the head, face and neck Burn percentage less than 50% ability to speak Obtaining a score of 23 and above in MMSE Having one to three molar teeth on both sides Not consuming food by mouth
Exclusion criteria:
Unwillingness to participate in the study Existence or history of addiction Electrical burns The need for surgery and grafting in the face and neck Taking all kinds of diuretic drugs
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning, the candidates to enter the study will be determined based on the entry and exit criteria, and then Balance-block randomization with 4 permutations will be used for random allocation. Blocks used include: 1. PPGG, 2. PGPG, 3. PGGP, 4. GGPP, 5. GPGP and 6. GPPG, in which the letter P (training) and the letter G (control) will be. RAS (Research Analysis and Statistics) software will be used to generate random blocks and a random number table will be used to select each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
After entering the control and intervention groups, a permanent nurse will be responsible for dressing and measuring the upper-lower diameter, maxillary diameter and frontal diameter throughout the study. In order to use chewing gums, a small package containing the code of each person participating in the study according to whether he is in control or intervention, is placed in the packages by the head nurse of the department on a daily basis, and that head of control or intervention It does not know the intervention of people. One of the researchers will also be present in the burn department daily at 10 am and 10 pm to monitor the measurement of the mentioned diameters on the face and neck and will write down the resulting numbers without knowing the allocation of the samples. and will enter in SPSS software. The statistical analyst will perform the statistical analysis without knowing the objectives of the research and the allocation of samples.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Ilam University of Medical Sciences
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.MEDILAM.REC.1403.081

Health conditions studied

1

Description of health condition studied
Burn edema
ICD-10 code
R60.0
ICD-10 code description
Localized edema

Primary outcomes

1

Description
Burn edema
Timepoint
Before the intervention, three days after the intervention
Method of measurement
Placing opened sterile gas on the burn areas to measure the amount of edema and transferring the size of the sterile gas used to determine the desired number in centimeters.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:From the second day of hospitalization, from 9:00 am to 9:00 pm, every three hours for 20 minutes for 4 times during the period of 3 days, the people of the intervention group chew 14 grams of Orbit mint gum. In addition, these individuals will routinely receive head and neck elevation.
Category
Rehabilitation

2

Description
Control group: People in the control group do not receive the intervention. All subjects participating in the study will receive head and neck elevation as per the routine.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ilam
Full name of responsible person
Alireza Vasiee
Street address
Ayatollah Heydari St
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
rezawest10@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Naser Abbasi
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Email
abbasi-n@medilam.ac.ir
Grant name
Vice President of Research and Technology of Ilam University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Nursing Clinical Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
631373847
Phone
+98 87 3222 7091
Email
rezawest10@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Nursing Clinical Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
631373847
Phone
+98 87 3222 7091
Fax
Email
rezawest10@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Alireza Vasiee
Position
Nursing Clinical Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pazhohesh Boulevard
City
Ilam
Province
Ilam
Postal code
631373847
Phone
+98 87 3222 7091
Email
rezawest10@gmail.com

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
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
Yes - There is 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
At the end of the study, a decision will be made by the research team
When the data will become available and for how long
At the end of the study, a decision will be made by the research team
To whom data/document is available
At the end of the study, a decision will be made by the research team
Under which criteria data/document could be used
At the end of the study, a decision will be made by the research team
From where data/document is obtainable
At the end of the study, a decision will be made by the research team
What processes are involved for a request to access data/document
At the end of the study, a decision will be made by the research team
Comments
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