- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05423054
Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients
The Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients Receiving Enteral Feeding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Enteral feeding has a vital role in the care of critically ill patients. It is considered a routine patients care in intensive care units. Enteral feeding is also a medical treatment as well as a part of nursing care. It is the preferred route of nutritional support in patients who are incapable of volitional intake. Additionally, it helps to stimulate peristaltic movements of the digestive system, improves blood supply, strengthens the immune system, improves recovery, and reduces physiological stress.
There are many complications associated with enteral feeding that can lead to an interruption of the feeding process, including gastrointestinal disorders, mechanical problems, fluid-electrolyte imbalance, and metabolic complications. Feeding intolerance is the most main digestive complication including nausea, vomiting, diarrhea, excess gastric residual volume, abdominal distention, and constipation.
Aspiration is also a significant side effect of delayed gastric emptying and increased GRV among CIPs. The Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition has recognized aspiration as one of the mutual complications of enteral feeding that should be evaluated before and during the feeding process. Consequently, prolonged ICU stays, and increased duration of mechanical ventilation, and mortality rate are side effects of feeding intolerance and aspiration. Additionally, abdominal massage is one of the complementary and alternative medicine which is significantly grown in recent years. Furthermore, it is an inexpensive, non-invasive intervention, and free from harmful side effects. Besides, it can increase the number of intestinal movements and lead to easier food movement along the gastrointestinal tract. In addition, it allows contraction of the diaphragm more fully, increases the capacity of the lung, and strengthens breathing.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients who are Full Outline of Unresponsiveness (FOUR) score is from 0-14 admitted to the previous ICUs who have nasogastric tube and within the first 24 hours from beginning enteral feeding will be included in the study.
- Age: adult CIPs ≥ 18 years.
- Gender: males and females.
- Negative gastric pH and glucose strip.
Exclusion Criteria:
- Gastric intolerance (delayed gastric empty).
- Patients who suffered from spinal cord injury, could not be properly positioned for massage due to severe trauma.
- Patients receiving prokinetic medications (to avoid interfering with the massage effects).
- Patients who have contraindications to abdominal massage such as ascites, abdominal aortic aneurysm, ileus, diarrhea, recent abdominal surgery, bleeding of GI, abdominal tumor, and undergoing radiotherapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: abdominal massage group
|
|
|
No Intervention: Control group
The Control group will receive routine care in the intensive care unit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Investigate the effect of abdominal massage on amount of gastric residual volume among critically ill patients receiving enteral feeding
Time Frame: 3 days
|
Change amount of gastric residual volume in milliliters
|
3 days
|
|
Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding
Time Frame: 3 days
|
Change abdominal circumference in Centimeter
|
3 days
|
|
Investigate the effect of abdominal massage on the occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Time Frame: 3 days
|
Change occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
|
3 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.0236
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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