Effect of Abdominal Massage on Patients in Intensive Care Unit

NCT06950580 | Not Yet Recruiting

• 1 other identifier: 2025/10
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intensive Care Unit Patients; Physiotherapy and Rehabilitation; Abdominal Massage

Keywords

Intensive care unit patients; Physiotherapy and rehabilitation; Abdominal massage; sepsis

Outcome Measures

Primary Outcomes (5)

• Incidence of Sepsis During 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

  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

  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

  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

  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)

Study Arms (2)

Abdominal Massage Group

EXPERIMENTAL

In addition to routine physiotherapy, patients will receive abdominal massage daily for 5 days.

Other: abdominal massage

Control Group

NO INTERVENTION

Routine physiotherapy will be continued for patients in this group.

Interventions

abdominal massage OTHER

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

Abdominal Massage Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karadeniz Technical University: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04