The effect of I LOV U massage on the gastric residual volume of patients under intestinal nutrition hospitalized in intensive care units of Ali Ibn Abi Taleb Hospital in Rafsanjan
Determining the effect of I LOV U massage on the amount of residual stomach volume in patients under enteral nutrition admitted to the special care units of Ali Bin Abitalib Rafsanjan Hospital.
Design
Clinical trial with control group, without blinding, randomized, on 80 patients. The random minimization method is used for randomization.
Settings and conduct
This research is carried out in the ICU department of Ali Bin Abitaleb Hospital in Rafsanjan. The participants are selected according to the available method and based on the entry criteria, and are placed in two intervention and control groups using the random minimization method. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Absence of oral feeding and having a nasogastric feeding tube
2- Glasgow coma scale less than 9
3- Absence of abdominal radiotherapy in the last 6 weeks
4- Not having a wound or recent surgery on the stomach or digestive system (10 days or less)
5- Age above 18 years
Exclusion criteria:
1- Discharge or death of the patient before completing the intervention period
2- Patients with liver failure, abdominal aortic aneurysm and ascites
3- Making the patient vomit
4- Patient being NPO
Intervention groups
In the intervention group, abdominal massage using the I LOV U method is used. The massage course for the intervention group is performed twice a day for 20 minutes each time for three days. The interval between two massages is 2 hours. GRV will be measured and checked every day before the intervention (9 am) and 1 hour after the second massage (12 noon).
There is no intervention in the control group.
Main outcome variables
The main outcome variable of the present study is the amount of remaining stomach volume.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231004059620N1
Registration date:2023-10-25, 1402/08/03
Registration timing:prospective
Last update:2023-10-25, 1402/08/03
Update count:0
Registration date
2023-10-25, 1402/08/03
Registrant information
Name
Zakiesadat Mirahmadiniri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3523 3575
Email address
z.mirahmadi.1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-14, 1402/08/23
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of I LOV U massage on the gastric residual volume of patients under intestinal nutrition hospitalized in intensive care units of Ali Ibn Abi Taleb Hospital in Rafsanjan
Public title
Investigating the effect of massage on the residual volume of the stomach
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of oral feeding and having a nasogastric feeding tube
Glasgow coma scale less than 9
Absence of abdominal radiotherapy in the last 6 weeks
Not having a wound or recent surgery on the stomach or digestive system (10 days or less)
Age above 18 years
Absence of paralysis of the veins based on the diagnosis of the attending physician
Not taking laxatives
Absence of pregnancy
Not taking prokinetic drugs such as metoclopramide and erythromycin within 8 hours before the intervention.
More than 24 hours have passed since the patient was admitted to the ICU
More than 24 hours have passed since the start of enteral nutrition
Patients with received gavage volume of 100-300 cc based on ward routine
Exclusion criteria:
Discharge or death of the patient before completing the intervention period
Patients with liver failure, abdominal aortic aneurysm and ascites
Making the patient vomit
Patient being NPO
Average body mass ≥ 30
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The method used for randomizing participants into two groups, one for the intervention and the other as the control, is known as "random minimization." To implement this method, the researchers first organize participants into classes based on a measure called the Apache score. These classes help categorize participants with similar characteristics. Then, the first to fourth participants are randomly assigned to either the intervention or control group. However, there's a unique aspect to this method: rather than solely relying on random chance, the researchers look at the total scores of specific indicators within each group. The sample is assigned to the group with a lower total score. This approach aims to create more balanced groups with respect to the selected indicators.
In simpler terms, random minimization starts by categorizing participants based on their Apache scores. Then, a combination of random selection and score comparison is used to assign participants to either the intervention or control group, ensuring that the groups are well-balanced with respect to these scores.
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 Ethics Committees of Rafsanjan University of Medical Sciences
Street address
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization - Building No. 3, Deputy for Research and Technology
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2022-12-07, 1401/09/16
Ethics committee reference number
IR.RUMS.REC.1401.176
Health conditions studied
1
Description of health condition studied
Patients admitted to the intensive care unit
ICD-10 code
E63
ICD-10 code description
Other nutritional deficiencies
Primary outcomes
1
Description
Gastric Residual Volume (GRV)
Timepoint
GRV is measured and checked every day before the intervention (9 am) and 1 hour after the second massage (12 noon).
Method of measurement
Standard 60 cc gavage syringe (manufactured by Hilal Medical Equipment Company with number 90077826837 available in the department)
Secondary outcomes
1
Description
Reducing the volume of the remaining stomach
Timepoint
GRV is measured and checked every day before the intervention (9 am) and 1 hour after the second massage (12 noon).
Method of measurement
Standard 60 cc gavage syringe (manufactured by Hilal Medical Equipment Company with number 90077826837 available in the department)
Intervention groups
1
Description
Intervention group: In the intervention group, abdominal massage using I LOV U method is used. The massage course for the intervention group will be performed twice a day for 20 minutes each time for three days. The interval between two massages is 2 hours. GRV is measured and checked every day before the intervention (9 am) and 1 hour after the second massage (12 noon). For female patients in the intervention group, abdominal massage is performed by the researcher himself and for male patients by the help of a male researcher under the supervision of the researcher in the bed where the patient is lying by placing a screen. Before the intervention, it is taught theoretically and practically with the help of a male researcher. I LOV U massage method: Circular massage is performed in a clockwise direction according to bowel movements on the abdominal wall with medium pressure. Abdominal massage circular movements in the form of the letters I, L, U, and O towards the movements of the large intestine and small intestine are performed as follows: for the left side massage, the patient is placed in a lying position on the back, and the massage is performed in a circular manner by writing The letter I is performed on the left upper quadrant (LUQ) and continues vertically downward along the left lower quadrant (LLQ) to the top. To write the letter L, massage starts from the right lower quadrant of the abdomen (RLQ) along the ascending part of the colon to the right upper quadrant (RUQ) and then from the transverse part of the colon massage to the left upper quadrant (LUQ). To write the letter O exactly around the navel, massage along the small intestine. To write the letter U, all the parts massaged by writing I and L are massaged continuously. To write the letter U, massage starts from the right lower quadrant (RLQ) along the ascending colon to the right upper quadrant (RUQ) and then continues along the transverse colon to the left upper quadrant (LUQ). Next, the left upper quadrant (LUQ) is massaged and continues vertically downward along the descending colon to the LLQ.
Category
Behavior
2
Description
Control group: no intervention is performed in the control group. In this group, only gavage is done based on the department's routine.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abi Taleb Hospital
Full name of responsible person
Seyyed Mohammad Ibrahim
Street address
Rafsanjan, Ali Ibn Abi Talib (A.S.) Square, Hazrat Ali Ibn Abi Talib (A.S.) Educational and Medical Center
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
aliebn_hospital@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Vahid Mohammadi Shahrokhi
Street address
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Zekiyeh Sadat Mirahmadi
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
z.mirahmadi.1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali KHodadadizadeh
Position
Assistant Professor of Health in Disasters and Emergencies, Department of Medical Surgical Nursing,
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
akhodadadi67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zekiyeh Sadat Mirahmadi
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
z.mirahmadi.1997@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions, or people who are also engaged in industry can apply to receive them.
Under which criteria data/document could be used
These documents can be used and accessed only for further investigation and clarification of the working method used in the present study.
From where data/document is obtainable
Ali KHodadadizadeh, faculty of Rafsanjan University of Medical Sciences
email: akhodadadi67@gmail.com
What processes are involved for a request to access data/document
Send an email to the person responsible for this project with details and logical reasons. Then, in case of discretion and approval, the data will be sent after 10 working days.