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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05423054
Other study ID # P.0236
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2022
Est. completion date December 30, 2022

Study information

Verified date June 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date December 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Abdominal massage
Patients will be positioned on their back while their knees will be flexed. Each patient will receive a 15-minute abdominal massage intervention half an hour before enteral feeding twice per day and the interval between two massages is 2 hours for consecutive 3 days. The PR will be standed on the right side of the patient during the massage practice. The abdominal massage technique will be delivered to each patient in four consecutive strokes including stroking, effleurage, kneading and vibration.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Outcome

Type Measure Description Time frame Safety issue
Primary Investigate the effect of abdominal massage on amount of gastric residual volume among critically ill patients receiving enteral feeding Change amount of gastric residual volume in milliliters 3 days
Primary Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding Change abdominal circumference in Centimeter 3 days
Primary Investigate the effect of abdominal massage on the occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding Change occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding 3 days
See also
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Recruiting NCT05892458 - Effect of Abdominal Massage on Prevention of Recurrent Common Bile Duct Stones After Endoscopic Sphincterotomy N/A
Completed NCT04373772 - Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery N/A