Effect of Abdominal Massage on Patients in Intensive Care Unit

April 25, 2025 updated by: A. Oguzhan KUCUK, Karadeniz Technical University

Investigation of the Effect of Abdominal Massage on Patients in Intensive Care Unit: Randomised Controlled Trial

Bowel motility can be affected by many factors such as immobilization, lack of fiber in the nutritional formula, inadequate fluid intake, and lack of privacy for toileting in patients hospitalized in the intensive care unit. Abdominal massage, which is one of the effective methods to increase intestinal motility, is accepted as an intervention that can be safely applied in patients.

The aim of our study was to investigate the effect of abdominal massage applied to patients hospitalized in the intensive care unit on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use.

Hypotheses H0: Abdominal massage application has no effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit.

H1: Abdominal massage application has an effect on sepsis, survival, discharge time from intensive care unit, amount and duration of antibiotic use in patients hospitalized in intensive care unit.

In this randomized controlled study, the data of patients who received abdominal massage for 5 days during routine physiotherapy applications and those who did not will be recorded. Randomization will be performed in a 1:1 ratio using a computer generated randomization schedule. The effect of abdominal massage on sepsis, survival, discharge time from intensive care, amount and duration of antibiotic use will be examined by using the data of 2 groups with and without abdominal massage in a randomized controlled trial.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged between 18 to 80 years
  • Patients hospitalized in the intensive care unit for more than 3 days
  • Body Mass Index less than 30 kg/m²
  • Patients who are not mobilized out of bed
  • Patients without any intervention contraindicating abdominal massage

Exclusion Criteria:

  • History of abdominal surgery
  • Active gastrointestinal bleeding
  • Patients discharged from ICU within less than 5 days after enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abdominal Massage Group
In addition to routine physiotherapy, patients will receive abdominal massage daily for 5 days.
Other: abdominal massage
In addition to routine physiotherapy, abdominal massage will be applied by the physiotherapist. The patient is positioned supine. The abdominal muscles are stroked three times, followed by colon stroking performed three times, and colon kneading performed three times. The massage is concluded by repeating the colon and abdominal stroking techniques in the same manner. Patients hospitalized in the intensive care unit will routinely receive abdominal massage twice daily by the physiotherapist
No Intervention: Control Group
Routine physiotherapy will be continued for patients in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Sepsis During Follow-Up
Time Frame: From ICU admission through Day 5 of follow-up

Sepsis will be assessed and recorded according to the Sepsis-3 definition, which requires the presence of suspected or confirmed infection and an acute increase in SOFA (Sequential Organ Failure Assessment) score of ≥2 points from baseline.

Data for sepsis diagnosis will be collected from daily clinical evaluations, vital signs, laboratory parameters (white blood cell count, procalcitonin, CRP, blood cultures), and organ function assessments. All assessments will be performed by ICU physicians and verified using electronic medical records.
From ICU admission through Day 5 of follow-up
Survival Rate During Follow-Up
Time Frame: From ICU admission through Day 5 of follow-up
Survival will be assessed by recording the number of patients who remain alive from ICU admission until the end of the 5-day follow-up period.
From ICU admission through Day 5 of follow-up
Length of ICU Stay
Time Frame: From ICU admission through Day 5 of follow-up
Length of stay in the intensive care unit will be measured in days, calculated as the number of days between the date of ICU admission and the date of ICU discharge. Information will be extracted from patient medical records.
From ICU admission through Day 5 of follow-up
Duration of Antibiotic Use
Time Frame: From ICU admission through Day 5 of follow-up, recorde in days
The total number of days each patient receives antibiotic treatment will be recorded during the 5-day follow-up period in the ICU. Data will be collected from medication administration records in the patient's medical file.
From ICU admission through Day 5 of follow-up, recorde in days
Amount of Antibiotic Consumption
Time Frame: From ICU admission through Day 5 of follow-up, recorded in milligrams (mg)
The cumulative amount of antibiotics administered to each patient during the 5-day follow-up period will be recorded in milligrams (mg). Data will be obtained from electronic medication administration records in the ICU.
From ICU admission through Day 5 of follow-up, recorded in milligrams (mg)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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