- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06075121
Enteral Nutrition and Abdominal Massage
The Effect of Abdominal Massage on Feeding Intolerance and Blood Sugar Level in Intensive Care Patients with Diabetes and Continuous Enteral Feeding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amasya, Turkey
- Amasya U
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Abdominal massage group
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 15 minutes.
|
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.
|
|
No Intervention: Control group
Routine treatment and care practices in the hospital will continue for 5 days without any additional intervention and the same data will be evaluated at the same time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastric residual volume
Time Frame: 5 days
|
Gastric residual volume will be done every four hours.
GRV measurement will be made 30 minutes after stopping feeding.
|
5 days
|
|
Abdominal Distension
Time Frame: 5 days
|
Abdominal Distension be evaluated 30 minutes after stopping feeding.
Abdominal distention control will be done using the palpation method.
|
5 days
|
|
Bristol stool scale scale
Time Frame: 5 days
|
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
|
|
Blood sugar
Time Frame: 5 days
|
Blood glucose levels will be checked four times a day at 10:00-14:00-18:00 and 22:00.
|
5 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AmasyaU-EY-208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intensive Care Unit Syndrome
-
University of MelbourneEnrolling by invitationICU Acquired Weakness | Intensive Care Unit Syndrome | Intensive Care Unit Acquired Weakness | Post Intensive Care Unit Syndrome | Post Intensive Care SyndromeAustralia
-
Indiana UniversityIndiana University HealthRecruitingPost Intensive Care Unit Syndrome | Intensive Care Unit Delirium | Intensive Care Acquired Cognitive Impairment | Virtual Reality Cognitive TrainingUnited States
-
University Hospital, BrestNot yet recruitingIntensive Care Unit SyndromeFrance
-
Zealand University HospitalNot yet recruitingPost-Intensive Care Syndrome (PICS) | Intensive Care Unit (ICU) Patients | Symptom Burden
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
Medical Centre LeeuwardenCompletedCritical Illness | Intensive Care Unit Acquired Weakness | Post Intensive Care Unit SyndromeNetherlands
-
Hospital Felix BulnesCompletedMechanical Ventilation Complication | Intensive Care Unit Syndrome | Intensive Care Unit Acquired Weakness | Intensive Care Unit Delirium | Intensive Care NeuropathyChile
-
University of CalgaryCanadian Institutes of Health Research (CIHR)CompletedDelirium | Post Intensive Care Unit Syndrome | Intensive Care Unit Delirium | Post Intensive Care Unit Syndrome FamilyCanada
-
Hospital Ernesto DornellesUnknownPTSD | Depressive Symptoms | Anxiety Symptoms | Intensive Care Unit Syndrome | Post Intensive Care Unit SyndromeBrazil
-
Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and Development; THE...Not yet recruitingSepsis | Critical Illness | Post Intensive Care Unit Syndrome | Intensive Care Unit Survivors | Microbiome Dysbiosis
Clinical Trials on Abdominal massage
-
TC Erciyes UniversityCompletedAbdominal Pain | Satisfaction, Patient | DistentionTurkey
-
University of PotsdamNot yet recruitingDysmenorrhea | Dysmenorrhea Primary | Dysmenorrhea Secondary | Dysmenorrhea Symptom
-
Marmara UniversityIstanbul University - CerrahpasaRecruiting
-
University Hospital, Clermont-FerrandRecruitingDigestive System Disease | Preterm Birth ComplicationFrance
-
Air Force Military Medical University, ChinaRecruitingCommon Bile Duct Stone | Abdominal MassageChina
-
Firat TukenmezCompleted
-
Saglik Bilimleri UniversitesiCompletedGastrointestinal SymptomsTurkey (Türkiye)
-
Bahçeşehir UniversityCompleted
-
University of Health Sciences LahoreCompleted
-
Mersin UniversityCompletedIntraabdominal PressureTurkey