Heat Application on Gastrointestinal System Functions
The Effect of Heat Application on Gastrointestinal System Functions in Patients Receiving Continuous Enteral Nutrition
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 26, 2024
January 1, 2024
29 days
November 28, 2023
January 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Gastric residual volume
GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.
7 days
Abdominal Distension
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
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 Outcomes (2)
Defecation Patterns
7 days
Vomiting
7 days
Study Arms (2)
Heat Application
EXPERIMENTALHeat will be applied to the abdominal/lumbar area for 15 minutes.
Control Group
NO INTERVENTIONNo intervention will be made.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 31710593BACKGROUNDZhang 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.
PMID: 36528462BACKGROUNDUysal 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.
PMID: 22472671BACKGROUNDMakino 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.
PMID: 28746113BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc.Prof.
Study Record Dates
First Submitted
November 28, 2023
First Posted
January 26, 2024
Study Start
February 1, 2024
Primary Completion
March 1, 2024
Study Completion
December 1, 2024
Last Updated
January 26, 2024
Record last verified: 2024-01