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IRCT20231004059620N1 IRCT 2023-10-25 Rafsanjan University of Medical Sciences Investigating the effect of massage on the residual volume of the stomach 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 2023-11-14 anticipated 80 Complete https://irct.ir/trial/73031 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Patients admitted to the intensive care unit. Intervention 1: 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. Intervention 2: Control group: no intervention is performed in the control group. In this group, only gavage is done based on the department's routine. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: 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. Conditions: These documents can be used and accessed only for further investigation and clarification of the working method used in the present study. Where to obtain: Ali KHodadadizadeh, faculty of Rafsanjan University of Medical Sciences email: akhodadadi67@gmail.com How to obtain: 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. Comments:
public Zekiyeh Sadat Mirahmadi
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 z.mirahmadi.1997@gmail.com Rafsanjan University of Medical Sciences scientific Ali KHodadadizadeh
Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 akhodadadi67@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 E63 Other nutritional deficiencies Behavior Behavior 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. Control group: no intervention is performed in the control group. In this group, only gavage is done based on the department's routine. 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). 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). Rafsanjan University of Medical Sciences Approved 2022-12-07 Research Ethics Committees of Rafsanjan University of Medical Sciences Rafsanjan - Imam Ali Boulevard - Rafsanjan University of Medical Sciences - Central Organization - Building No. 3, Deputy for Research and Technology Rafsanjan Kerman Iran (Islamic Republic of)