Effect of Abdominal Massage on Patients in Intensive Care Unit
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKaradeniz Technical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
History of abdominal surgery
Active gastrointestinal bleeding
Patients discharged from ICU within less than 5 days after enrollment
Trial design
Design model
Parallel
Treatments tested in this trial
abdominal massage
Other interventionIn 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
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Abdominal Massage GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From ICU admission through Day 5 of follow-up2
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.
Time frame
From ICU admission through Day 5 of follow-up3
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.
Time frame
From ICU admission through Day 5 of follow-up4
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.
Time frame
From ICU admission through Day 5 of follow-up, recorde in daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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