NCT05423054

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 29, 2022

Last Update Submit

June 14, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • Investigate the effect of abdominal massage on abdominal circumference among critically ill patients receiving enteral feeding

    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

    Change occurrence of vomiting, constipation, and aspiration among critically ill patients receiving enteral feeding

    3 days

Study Arms (2)

abdominal massage group

EXPERIMENTAL

* 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.

Other: Abdominal massage

Control group

NO INTERVENTION

The Control group will receive routine care in the intensive care unit

Interventions

* 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.

abdominal massage group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator in Critical Care and Emergency Nursing Department, Faculty of Nursing, Mansoura University

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 21, 2022

Study Start

June 20, 2022

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06