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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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Massage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 29, 2022
    Last Updated
    June 14, 2022
    Sponsor
    Mansoura University
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    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

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