Clinical trial NCT06950580: Effect of Abdominal Massage on Patients in Intensive Care Unit
Official title: Investigation of the Effect of Abdominal Massage on Patients in Intensive Care Unit: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intensive Care Unit Patients
Physiotherapy and Rehabilitation
Abdominal Massage
Keywords: Intensive care unit patients
Physiotherapy and rehabilitation
Abdominal massage
sepsis
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Sepsis During Follow-Up
timeFrame: From ICU admission through Day 5 of follow-up
measure: Survival Rate During Follow-Up
timeFrame: From ICU admission through Day 5 of follow-up
measure: Length of ICU Stay
timeFrame: From ICU admission through Day 5 of follow-up
measure: Duration of Antibiotic Use
timeFrame: From ICU admission through Day 5 of follow-up, recorde in days
measure: Amount of Antibiotic Consumption
timeFrame: From ICU admission through Day 5 of follow-up, recorded in milligrams (mg)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: