Investigating the effect of abdominal massage on gavage tolerance in children and adolescents under special care at Shahid Bahoner Hospital in Kerman in 2023-2024
Investigating the effect of abdominal massage on gavage tolerance in children and adolescents under special care at Shahid Bahoner Hospital in Kerman in 2023-2024
Design
This study is a two-blind phase two randomized clinical trial, the sample size is 35 people for each group (totally 70). After selecting the patients, the block randomization method with 4, 6, and 8 block sizes (with SPSS software) will be used to assign people to two groups.
Settings and conduct
This study will be conducted as a clinical trial in the special care department of Bahoner Hospital in Kerman.
Participants/Inclusion and exclusion criteria
Obtaining informed consent, children and adolescents between 8-18 years needing hospitalization in the intensive care unit, having an NG tube, - having a Glasgow coma score less than 8 (because these patients usually require gavage), intubation under mechanical ventilation for More than 3 days
Exclusion criteria include: patients who were taking prokinetic drugs (due to interference with the effects of massage)
Intervention groups
A group that receives abdominal massage in addition to routine care.
Main outcome variables
Determination of gastric residual volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230723058898N1
Registration date:2023-12-07, 1402/09/16
Registration timing:registered_while_recruiting
Last update:2023-12-07, 1402/09/16
Update count:0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Fateme Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3285 0177
Email address
f_ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of abdominal massage on gavage tolerance in children and adolescents under special care at Shahid Bahoner Hospital in Kerman in 2023-2024
Public title
Investigating the effect of abdominal massage on gavage tolerance in children and adolescents under special care at Shahid Bahoner Hospital in Kerman in 2023-2024
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Obtaining informed consent
Children and adolescents between 8-18 years need to be hospitalized in the intensive care unit
Having an NG tube
Having a Glasgow Coma Scale less than 8 (because these patients usually need gavage)
Intubation under ventilation mechanical for more than 3 days
Exclusion criteria:
Patients taking prokinetic drugs (due to interference with use)
Age
From 8 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the patients, the block randomization method with 4, 6, and 8 block sizes (with SPSS software) will be used to assign people to two groups. will be. In this method, each person is assigned a unique code and it will help the blinding process. They will be placed in one of the intervention (35 patients) and control (35 patients) groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the patients, block randomization method with 4, 6 and 8 block sizes (with SPSS software) will be used to assign people to two groups. will be. In this method, each person is assigned a unique code and it will help the blinding process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-11-10, 1402/08/19
Ethics committee reference number
IR.KMU.AH.REC.1402.063
Health conditions studied
1
Description of health condition studied
Intolerance of gavage in children and adolescents admitted to the intensive care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of the remaining volume of the stomach
Timepoint
Abdominal massage is performed at 8:30 and 20:30 and the remaining volume of the stomach is measured before each gavage in two groups (the first time is considered as the zero stage and before the start of the intervention. ). Therefore, the first time to determine the residual volume of the stomach in both groups is before gavage at 6 am. Then, in the model group, it is done half an hour before gavage at 9 am, and then the remaining volume of the stomach before gavage is measured with a spirae by gavage syringe three times in a similar position in all care patients, which is 30-45 degrees below the patient's head. be controlled
Method of measurement
Aspiration with a gavage syringe and pouring into a special graduated container
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People who are subjected to an intervention (abdominal massage), then the result of that intervention is checked on the same group.
Category
Treatment - Other
2
Description
Control group: People who do not take any action and gavage is performed according to the usual method of the special care department and like the intervention group by the nursing staff of the department and 7 times a day.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahoner Hospital, Kerman
Full name of responsible person
Dr. Mahdi Ahmadinejad
Street address
Sepah Street, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
f_ahmadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mahdi Ahmadinejad
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
mehdia50@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
50
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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mahdi Ahmadinejad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
mehdia50@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatema Ahmadi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
f_ahmadi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fateme Ahmadi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
f_ahmadi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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 data obtained from the participants in this study will be provided to the applicants in the form of a PDF file after the completion of the study.
When the data will become available and for how long
At least six months after the start of the study
To whom data/document is available
Project facilitators and collaborators, physicians associated with the disease and poisoners and their parents
Under which criteria data/document could be used
To improve the nutrition of patients in the intensive care unit
From where data/document is obtainable
Refer to Ms. Fatemeh Ahmadi
What processes are involved for a request to access data/document
By sending a message to the respondent's email, the file will be provided to the applicant.