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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06075121
Other study ID # AmasyaU-EY-208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 12, 2023
Est. completion date June 2024

Study information

Verified date October 2023
Source Amasya University
Contact Nese Uysal
Phone (90)3582181767
Email nese.uysal@amasya.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be conducted to determine the effect of abominal massage on feeding intolerance and blood sugar levels in intensive care patients who are continuously feeding enterally and have diabetes.


Description:

Introduction: Many multiple and challenging problems are encountered in patients followed in intensive care. The most important of these symptoms is nutritional problems. One of the most commonly used methods in the treatment of nutritional problems is enteral nutrition. In addition to its beneficial results, gastrointestinal problems such as abdominal distension, constipation, diarrhea, nausea and vomiting may be encountered in enteral fed individuals in intensive care units. Although different methods are used in the management of complications that may develop in enterally fed patients, abdominal massage, which is one of the non-invasive nursing practices, has been shown to reduce feeding intolerance and balance blood glucose levels. Purpose: This study will be conducted to determine the effect of abominal massage applied to intensive care patients who are continuously fed enterally and have diabetes, on feeding intolerance and blood sugar levels. Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 64 patients hospitalized in the intensive care units of a state hospital in Merzifon and who meet the inclusion criteria. Research data will be collected using the clinical status information form, patient parameters monitoring form, and Bristol stool scale. Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. For the control group, routine treatment and care practices in the hospital will continue without any additional intervention for these 5 days, and the same data will be evaluated at the same time. Conclusion: It is thought that abdominal massage applied to intensive care patients with diabetes who are continuously fed enterally will reduce feeding intolerance and affect blood sugar levels.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: The age of 18 years and over Diagnosed with diabetes mellitus Having just started continuous enteral feeding via nasogastric tube Glasgow coma scale >3 Patients who do not have a wound in the abdominal area Patients without current diarrhea, constipation, vomiting, abdominal distension Patients who gave their consent to participate in the research Exclusion Criteria: Patients who had started enteral feeding before starting the study Patients who received radiotherapy to the abdominal area Abdominal surgery within the last three months Patients with ileus Patients using medications that affect gastrointestinal motility

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Abdominal massage
Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. Enteral nutrition will be interrupted twice a day for 5 days, between 09.30-10.00 in the morning and 21.30-22.00 in the evening, and patients will receive an abdominal massage for 15 minutes.

Locations

Country Name City State
Turkey Amasya U Amasya

Sponsors (1)

Lead Sponsor Collaborator
Amasya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastric residual volume Gastric residual volume will be done every four hours. GRV measurement will be made 30 minutes after stopping feeding. 5 days
Primary Abdominal Distension Abdominal Distension be evaluated 30 minutes after stopping feeding. Abdominal distention control will be done using the palpation method. 5 days
Primary Bristol stool scale scale This scale is designed to classify an individual's bowel movements into seven separate categories of stool. According to the "Bristol Stool Consistency Scale", Type 1 and Type 2 indicate constipation, Type 3 and Type 4 indicate normal defecation, and Type 5, Type 6 and Type 7 indicate diarrhea. 5 days
Primary Blood sugar Blood sugar levels will be checked twice a day, at 10:00 in the morning and at 22:00 in the evening 5 days
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