Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients
Primary Purpose
Abdominal Massage
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abdominal massage
Sponsored by
About this trial
This is an interventional other trial for Abdominal Massage
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
abdominal massage group
Control group
Arm Description
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.
The Control group will receive routine care in the intensive care unit
Outcomes
Primary Outcome Measures
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
Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding
Change abdominal circumference in Centimeter
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05423054
Brief Title
Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients
Official Title
The Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients Receiving Enteral Feeding
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to investigate the effect of abdominal massage on gastrointestinal outcomes among critically ill patients receiving enteral feeding.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Massage
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
abdominal massage group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The Control group will receive routine care in the intensive care unit
Intervention Type
Other
Intervention Name(s)
Abdominal massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Investigate the effect of abdominal massage on amount of gastric residual volume among critically ill patients receiving enteral feeding
Description
Change amount of gastric residual volume in milliliters
Time Frame
3 days
Title
Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding
Description
Change abdominal circumference in Centimeter
Time Frame
3 days
Title
Investigate the effect of abdominal massage on the occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Description
Change occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effect of Abdominal Massage on Gastrointestinal Outcomes Among Critically Ill Patients
We'll reach out to this number within 24 hrs