Intensive Care Unit PatientsNCT06950580
Effect of Abdominal Massage on Patients in Intensive Care Unit
A study testing abdominal massage in people with Intensive Care Unit Patients and Physiotherapy and Rehabilitation, run by Karadeniz Technical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intensive Care Unit Patients, Physiotherapy and Rehabilitation, Abdominal Massage
- What is being tested?
- abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of abdominal surgery
- Active gastrointestinal bleeding
- Patients discharged from ICU within less than 5 days after enrollment
About this study
Official title: 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.
Read more
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.
- Being tested
- abdominal massage
- Keywords
- Intensive care unit patients, Physiotherapy and rehabilitation, Abdominal massage, sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal massageOther
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
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Group | Experimental | In addition to routine physiotherapy, patients will receive abdominal massage daily for 5 days. Receives: Other: abdominal massage |
| Control Group | No intervention | Routine physiotherapy will be continued for patients in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From ICU admission through Day 5 of follow-up, recorded in milligrams (mg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Oguzhan KUCUK, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950580
- Sponsor's protocol ID
- 2025/10
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Abdominal Massage on Patients in Intensive Care Unit: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06950580
- Acronym / sponsor ID
- 2025/10
- Keywords
- Intensive care unit patients, Physiotherapy and rehabilitation, Abdominal massage, sepsis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Group | Experimental | Other: abdominal massageIn addition to routine physiotherapy, patients will receive abdominal massage daily for 5 days. |
| Control Group | No intervention | –Routine physiotherapy will be continued for patients in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- History of abdominal surgery
- Active gastrointestinal bleeding
- Patients discharged from ICU within less than 5 days after enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal massageIn 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 | Other | Abdominal Massage Group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal massage in people with Intensive Care Unit Patients and Physiotherapy and Rehabilitation, run by Karadeniz Technical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Sepsis During Follow-Up (time frame: From ICU admission through Day 5 of follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.