Intensive Care Unit SyndromeNCT06075121
Enteral Nutrition and Abdominal Massage
A study testing Abdominal massage in people with Intensive Care Unit Syndrome, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to determine the effect of abominal massage on feeding intolerance and blood sugar levels in intensive care patients who are continuously feeding enterally and have diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2023to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The age of 18 years and over
- Diagnosed with diabetes mellitus
- Having just started continuous enteral feeding via nasogastric tube
- Glasgow coma scale >3
- Patients who do not have a wound in the abdominal area
- Patients without current diarrhea, constipation, vomiting, abdominal distension
- Patients who gave their consent to participate in the research
Who cannot join
- Patients who had started enteral feeding before starting the study
- Patients who received radiotherapy to the abdominal area
- Abdominal surgery within the last three months
- Patients with ileus
- Patients using medications that affect gastrointestinal motility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Abdominal Massage on Feeding Intolerance and Blood Sugar Level in Intensive Care Patients with Diabetes and Continuous Enteral Feeding
This study will be conducted to determine the effect of abominal massage on feeding intolerance and blood sugar levels in intensive care patients who are continuously feeding enterally and have diabetes.
Read the detailed description
Introduction: Many multiple and challenging problems are encountered in patients followed in intensive care. The most important of these symptoms is nutritional problems. One of the most commonly used methods in the treatment of nutritional problems is enteral nutrition. In addition to its beneficial results, gastrointestinal problems such as abdominal distension, constipation, diarrhea, nausea and vomiting may be encountered in enteral fed individuals in intensive care units. Although different methods are used in the management of complications that may develop in enterally fed patients, abdominal massage, which is one of the non-invasive nursing practices, has been shown to reduce feeding intolerance and balance blood glucose levels.
Purpose: This study will be conducted to determine the effect of abominal massage applied to intensive care patients who are continuously fed enterally and have diabetes, on feeding intolerance and blood sugar levels.
Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 64 patients hospitalized in the intensive care units of a state hospital in Merzifon and who meet the inclusion criteria. Research data will be collected using the clinical status information form, patient parameters monitoring form, and Bristol stool scale. Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. For the control group, routine treatment and care practices in the hospital will continue without any additional intervention for these 5 days, and the same data will be evaluated at the same time.
Conclusion: It is thought that abdominal massage applied to intensive care patients with diabetes who are continuously fed enterally will reduce feeding intolerance and affect blood sugar levels.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Abdominal massage
- Keywords
- massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageOther
Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. Enteral nutrition will be interrupted twice a day for 5 days, between 09.30-10.00 in the morning and 21.30-22.00 in the evening, and patients will receive an abdominal massage for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal massage group | Experimental | Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening for 15 minutes. Receives: Other: Abdominal massage |
| Control group | No intervention | Routine treatment and care practices in the hospital will continue for 5 days without any additional intervention and the same data will be evaluated at the same time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume
Gastric residual volume will be done every four hours. GRV measurement will be made 30 minutes after stopping feeding.
Measured: 5 days
Abdominal Distension
Abdominal Distension be evaluated 30 minutes after stopping feeding. Abdominal distention control will be done using the palpation method.
Measured: 5 days
Bristol stool scale scale
This scale is designed to classify an individual's bowel movements into seven separate categories of stool. According to the "Bristol Stool Consistency Scale", Type 1 and Type 2 indicate constipation, Type 3 and Type 4 indicate normal defecation, and Type 5, Type 6 and Type 7 indicate diarrhea.
Measured: 5 days
Blood sugar
Blood glucose levels will be checked four times a day at 10:00-14:00-18:00 and 22:00.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start12 Jun 2023
- Primary completion22 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075121
- Sponsor's protocol ID
- AmasyaU-EY-208
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Feeding Intolerance and Blood Sugar Level in Intensive Care Patients with Diabetes and Continuous Enteral Feeding
- ClinicalTrials.gov ID
- NCT06075121
- Acronym / sponsor ID
- AmasyaU-EY-208
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 10 Oct 2023 (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.
This study will be conducted to determine the effect of abominal massage on feeding intolerance and blood sugar levels in intensive care patients who are continuously feeding enterally and have diabetes.
Detailed description
Introduction: Many multiple and challenging problems are encountered in patients followed in intensive care. The most important of these symptoms is nutritional problems. One of the most commonly used methods in the treatment of nutritional problems is enteral nutrition. In addition to its beneficial results, gastrointestinal problems such as abdominal distension, constipation, diarrhea, nausea and vomiting may be encountered in enteral fed individuals in intensive care units. Although different methods are used in the management of complications that may develop in enterally fed patients, abdominal massage, which is one of the non-invasive nursing practices, has been shown to reduce feeding intolerance and balance blood glucose levels.
Purpose: This study will be conducted to determine the effect of abominal massage applied to intensive care patients who are continuously fed enterally and have diabetes, on feeding intolerance and blood sugar levels.
Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 64 patients hospitalized in the intensive care units of a state hospital in Merzifon and who meet the inclusion criteria. Research data will be collected using the clinical status information form, patient parameters monitoring form, and Bristol stool scale. Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. For the control group, routine treatment and care practices in the hospital will continue without any additional intervention for these 5 days, and the same data will be evaluated at the same time.
Conclusion: It is thought that abdominal massage applied to intensive care patients with diabetes who are continuously fed enterally will reduce feeding intolerance and affect blood sugar levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal massage group | Experimental | Other: Abdominal massagePatients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening for 15 minutes. |
| Control group | No intervention | –Routine treatment and care practices in the hospital will continue for 5 days without any additional intervention and the same data will be evaluated at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The age of 18 years and over
- Diagnosed with diabetes mellitus
- Having just started continuous enteral feeding via nasogastric tube
- Glasgow coma scale >3
- Patients who do not have a wound in the abdominal area
Key exclusion criteria (5 listed)
- Patients who had started enteral feeding before starting the study
- Patients who received radiotherapy to the abdominal area
- Abdominal surgery within the last three months
- Patients with ileus
- Patients using medications that affect gastrointestinal motility
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 massagePatients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. Enteral nutrition will be interrupted twice a day for 5 days, between 09.30-10.00 in the morning and 21.30-22.00 in the evening, and patients will receive an abdominal massage for 15 minutes. | Other | Abdominal massage group |
Primary outcome
Gastric residual volume
Time frame: 5 days
Gastric residual volume will be done every four hours. GRV measurement will be made 30 minutes after stopping feeding.
Abdominal Distension
Time frame: 5 days
Abdominal Distension be evaluated 30 minutes after stopping feeding. Abdominal distention control will be done using the palpation method.
Bristol stool scale scale
Time frame: 5 days
This scale is designed to classify an individual's bowel movements into seven separate categories of stool. According to the "Bristol Stool Consistency Scale", Type 1 and Type 2 indicate constipation, Type 3 and Type 4 indicate normal defecation, and Type 5, Type 6 and Type 7 indicate diarrhea.
Blood sugar
Time frame: 5 days
Blood glucose levels will be checked four times a day at 10:00-14:00-18:00 and 22:00.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Intensive Care Unit Syndrome
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage in people with Intensive Care Unit Syndrome, run by Amasya University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastric residual volume (time frame: 5 days). The study lists 4 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 20 Jan 2025.