Enteral NutritionNCT06237725
Abdominal Massage in Enteral Nutrition Patients
A study testing Nutrition of Continuous and Nutrition of Bolus in people with Enteral Nutrition and Gastrointestinal System--Abnormalities, run by TC Erciyes University.
Trial summary
Complications related to the gastrointestinal system may arise in patients receiving enteral nutrition through continuous and bolus infusion. These complications include constipation, diarrhea, nausea, vomiting, abdominal distension, increased gastric residual volume, and abdominal pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enteral Nutrition, Gastrointestinal System--Abnormalities
- What is being tested?
- Nutrition of Continuous and Nutrition of Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Nov 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
- Patients in intensive care
- Those aged 18 and above
- Patients being fed through a nasogastric tube
- Patients on the first day of enteral nutrition
- Patients without wounds in the abdominal region
- Those who have not undergone abdominal surgery in the last 6 months
Show all 14Show fewer
- Patients not receiving radiotherapy/chemotherapy
- Patients without a diagnosis of bowel obstruction
- Patients without diarrhea and constipation
- Patients with a Glasgow Coma Scale (GKS) > 3
- Those with an APACHE II score > 16
- Patients not taking prokinetic agents
- Patients not taking laxative medications
- Patients without any contraindications for abdominal massage (to be determined in consultation with the primary physician)
Who cannot join
- Patients for whom enteral nutrition is discontinued during the study
- Patients with interrupted enteral nutrition
- Patients who have started prokinetic agents
- The study will be terminated for patients who have started laxative medication.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Abdominal Massage on Gastrointestinal System Functions in Patients Nutrition Enterally With Continuous and Bolus Infusion.
Complications related to the gastrointestinal system may arise in patients receiving enteral nutrition through continuous and bolus infusion. These complications include constipation, diarrhea, nausea, vomiting, abdominal distension, increased gastric residual volume, and abdominal pain. The aim of this study is to determine the impact of abdominal massage applied to patients receiving enteral nutrition through continuous or bolus infusion on gastrointestinal system functions. For this purpose, 164 patients meeting the inclusion criteria will be randomized, and four groups will be defined. Half will constitute the experimental group, and the others will form the control group. In our study, the effects of massage on symptom control will be evaluated by comparing symptoms in patients receiving both forms of nutrition. Thus, the evaluation and control of medical conditions (symptoms) such as constipation, diarrhea, vomiting, increased abdominal distension, and increased gastric residual volume are targeted.
- Being tested
- Nutrition of Continuous, Nutrition of Bolus
- Keywords
- Enteral Nutrition, Continuous and Bolus Infusion, Abdominal Massage, Gastrointestinal System Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition of ContinuousOther
The researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days.
Nutrition of BolusOther
The researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition of Continuous | Experimental | Experimental: Intervention Group to Nutrition of Continuous Receives: Other: Nutrition of Continuous |
| Control Group Nutrition of Continuous | No intervention | Control Group to Nutrition of Continuous |
| Nutrition of Bolus | Experimental | Experimental: Intervention Group to Nutrition of Bolus Receives: Other: Nutrition of Bolus |
| Control Group Nutrition of Bolus | No intervention | Control Group to Nutrition of Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume
GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.
Measured: 7 days
Abdominal Distension
Abdominal distension will be evaluated 30 minutes after stopping feeding. The palpation method will be used. Additionally, the abdominal circumference will be measured with a tape measure. It will be evaluated before and after application.
Measured: 7 days
Bowel sounds
Bowel sounds should be evaluated 30 minutes after stopping feeding. Bowel sounds are listened to with a stethoscope for one minute. It will be evaluated before and after the application.
Measured: 7 days
Secondary outcomes (2)
Defecation patterns
measure defecation frequency and nature
Measured: 7 days
Vomiting
How many times the patient vomited during the day is recorded
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ceyhan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237725
- Sponsor's protocol ID
- MassageGIS
- Status last verified
- Jan 2024
- First submitted
- 25 Nov 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a.
PubMed 22472671Wang X, Sun J, Li Z, Luo H, Zhao M, Li Z, Li Q. Impact of abdominal massage on enteral nutrition complications in adult critically ill patients: A systematic review and meta-analysis. Complement Ther Med. 2022 Mar;64:102796. doi: 10.1016/j.ctim.2021.102796. Epub 2021 Dec 10.
PubMed 34902566Dehghan M, Malakoutikhah A, Ghaedi Heidari F, Zakeri MA. The Effect of Abdominal Massage on Gastrointestinal Functions: a Systematic Review. Complement Ther Med. 2020 Nov;54:102553. doi: 10.1016/j.ctim.2020.102553. Epub 2020 Sep 12.
PubMed 33183670Cetinkaya O, Ovayolu O, Ovayolu N. The Effect of Abdominal Massage on Enteral Complications in Geriatric Patients. SAGE Open Nurs. 2020 Oct 13;6:2377960820963772. doi: 10.1177/2377960820963772. eCollection 2020 Jan-Dec.
PubMed 35155761Zhang W, Zhou W, Kong Y, Li Q, Huang X, Zhao B, Su H, Chen S, Shen X, Qiu Z. The effect of abdominal massage on enteral nutrition tolerance in patients on mechanical ventilation: A Randomized Controlled Study. Intensive Crit Care Nurs. 2023 Apr;75:103371. doi: 10.1016/j.iccn.2022.103371. Epub 2022 Dec 15.
PubMed 36528462
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Gastrointestinal System Functions in Patients Nutrition Enterally With Continuous and Bolus Infusion.
- ClinicalTrials.gov ID
- NCT06237725
- Acronym / sponsor ID
- MassageGIS
- Keywords
- Enteral Nutrition, Continuous and Bolus Infusion, Abdominal Massage, Gastrointestinal System Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
Complications related to the gastrointestinal system may arise in patients receiving enteral nutrition through continuous and bolus infusion. These complications include constipation, diarrhea, nausea, vomiting, abdominal distension, increased gastric residual volume, and abdominal pain. The aim of this study is to determine the impact of abdominal massage applied to patients receiving enteral nutrition through continuous or bolus infusion on gastrointestinal system functions. For this purpose, 164 patients meeting the inclusion criteria will be randomized, and four groups will be defined. Half will constitute the experimental group, and the others will form the control group. In our study, the effects of massage on symptom control will be evaluated by comparing symptoms in patients receiving both forms of nutrition. Thus, the evaluation and control of medical conditions (symptoms) such as constipation, diarrhea, vomiting, increased abdominal distension, and increased gastric residual volume are targeted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nutrition of Continuous | Experimental | Other: Nutrition of ContinuousExperimental: Intervention Group to Nutrition of Continuous |
| Control Group Nutrition of Continuous | No intervention | –Control Group to Nutrition of Continuous |
| Nutrition of Bolus | Experimental | Other: Nutrition of BolusExperimental: Intervention Group to Nutrition of Bolus |
| Control Group Nutrition of Bolus | No intervention | –Control Group to Nutrition of Bolus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients in intensive care
- Those aged 18 and above
- Patients being fed through a nasogastric tube
- Patients on the first day of enteral nutrition
- Patients without wounds in the abdominal region
Key exclusion criteria (4 listed)
- Patients for whom enteral nutrition is discontinued during the study
- Patients with interrupted enteral nutrition
- Patients who have started prokinetic agents
- The study will be terminated for patients who have started laxative medication.
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 |
|---|---|---|
| Nutrition of ContinuousThe researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days. | Other | Nutrition of Continuous |
| Nutrition of BolusThe researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days. | Other | Nutrition of Bolus |
Primary outcome
Gastric residual volume
Time frame: 7 days
GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.
Abdominal Distension
Time frame: 7 days
Abdominal distension will be evaluated 30 minutes after stopping feeding. The palpation method will be used. Additionally, the abdominal circumference will be measured with a tape measure. It will be evaluated before and after application.
Bowel sounds
Time frame: 7 days
Bowel sounds should be evaluated 30 minutes after stopping feeding. Bowel sounds are listened to with a stethoscope for one minute. It will be evaluated before and after the application.
2 secondary outcomes
Defecation patterns
Time frame: 7 days
Vomiting
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 22472671Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a.
- Background: PubMed 34902566Wang X, Sun J, Li Z, Luo H, Zhao M, Li Z, Li Q. Impact of abdominal massage on enteral nutrition complications in adult critically ill patients: A systematic review and meta-analysis. Complement Ther Med. 2022 Mar;64:102796. doi: 10.1016/j.ctim.2021.102796. Epub 2021 Dec 10.
- Background: PubMed 33183670Dehghan M, Malakoutikhah A, Ghaedi Heidari F, Zakeri MA. The Effect of Abdominal Massage on Gastrointestinal Functions: a Systematic Review. Complement Ther Med. 2020 Nov;54:102553. doi: 10.1016/j.ctim.2020.102553. Epub 2020 Sep 12.
- Background: PubMed 35155761Cetinkaya O, Ovayolu O, Ovayolu N. The Effect of Abdominal Massage on Enteral Complications in Geriatric Patients. SAGE Open Nurs. 2020 Oct 13;6:2377960820963772. doi: 10.1177/2377960820963772. eCollection 2020 Jan-Dec.
- Background: PubMed 36528462Zhang W, Zhou W, Kong Y, Li Q, Huang X, Zhao B, Su H, Chen S, Shen X, Qiu Z. The effect of abdominal massage on enteral nutrition tolerance in patients on mechanical ventilation: A Randomized Controlled Study. Intensive Crit Care Nurs. 2023 Apr;75:103371. doi: 10.1016/j.iccn.2022.103371. Epub 2022 Dec 15.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition of Continuous and Nutrition of Bolus in people with Enteral Nutrition and Gastrointestinal System--Abnormalities, run by TC Erciyes 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 14 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem Ceyhan (+9035220766 ext. 28561, ozlemg@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric residual volume (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237725, which also lists 5 linked publications.
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 1 Feb 2024.