- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06225687
Heat Application on Gastrointestinal System Functions
January 25, 2024 updated by: Özlem Ceyhan, TC Erciyes University
The Effect of Heat Application on Gastrointestinal System Functions in Patients Receiving Continuous Enteral Nutrition
Complications related to the gastrointestinal system can occur in patients receiving enteral nutrition.
These complications may include nausea, vomiting, diarrhea, constipation, decreased bowel sounds, abdominal distension, increased gastric residual volume, and abdominal pain.
To prevent and treat food intolerance, as well as to increase gastric emptying, the use of prokinetic agents is often preferred.
However, these drugs have various side effects, such as abdominal cramps, allergies, bronchospasm, cardiac issues, and pancreatic disorders.
One non-pharmacological method that can be applied to increase bowel motility and reduce abdominal distension and constipation is heat application.
The aim of this study is to determine the effect of heat application to the abdominal and lumbar regions, using a hot water bag, on gastrointestinal system functions in patients receiving continuous enteral nutrition.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Özlem Ceyahn
- Phone Number: 28561 +903522076666
- Email: ozlemg@erciyes.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Intensive care unit patients
- Individuals aged 18 and above
- Patients receiving enteral nutrition via nasogastric tube
- Patients on the first day of enteral nutrition
- Those receiving standard enteral nutrition solution
- Patients without wounds in the abdominal region
- Individuals who have not undergone abdominal surgery in the last 6 months
- Patients not undergoing radiation/chemotherapy
- Those with a high-output fistula without ileus problems
- 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 the application of heat, such as neuropathy (to be determined in consultation with the primary doctor).
Exclusion Criteria:
- Patients in whom enteral nutrition is discontinued during the study
- Patients transitioning to a product other than the standard one in enteral nutrition
- Patients who temporarily pause enteral nutrition
- Patients who have started prokinetic agents
- The study will be terminated in patients who have started taking laxative medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Heat Application
Heat will be applied to the abdominal/lumbar area for 15 minutes.
|
The researcher will conduct daily measurements of gastric residual volume (GRV) and abdominal circumference, listen to bowel sounds, and assess distension from the first day of enteral nutrition initiation.
Additionally, they will record the frequency of vomiting/defecation.
Subsequently, a 15-minute hot application will be applied to the abdominal/lumbar region.
|
|
No Intervention: Control Group
No intervention will be made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 days
|
|
Abdominal Distension
Time Frame: 7 days
|
Abdominal distension will be assessed 30 minutes after stopping feeding.
The palpation method will be used.
Additionally, abdominal circumference will be measured with a tape measure.
Evaluation will be made before and after the intervention.
|
7 days
|
|
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 intervention.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Defecation Patterns
Time Frame: 7 days
|
measure defecation frequency and nature
|
7 days
|
|
Vomiting
Time Frame: 7 days
|
The number of vomitings during the day is recorded
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Dehghan M, Fatehi Poor A, Mehdipour-Rabori R, Ahmadinejad M. Effect of abdominal massage on prevention of aspiration in intubated and enterally fed patients: A randomized controlled trial. J Complement Integr Med. 2020 Sep 23;17(3). doi: 10.1515/jcim-2017-0124.
- Zhang 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.
- Makino Y, Choe MA. Effects of Hot Packs on Small-Intestinal Motility Measured by Doppler Ultrasound and Subjective Feelings in Normal Adults. Gastroenterol Nurs. 2017 Jul/Aug;40(4):279-286. doi: 10.1097/SGA.0000000000000222.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
January 25, 2024
First Posted (Estimated)
January 26, 2024
Study Record Updates
Last Update Posted (Estimated)
January 26, 2024
Last Update Submitted That Met QC Criteria
January 25, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HeatAppGastro
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.