Clinical trial NCT06225687: Heat Application on Gastrointestinal System Functions
Official title: The Effect of Heat Application on Gastrointestinal System Functions in Patients Receiving Continuous Enteral Nutrition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Enteral Nutrition
Gastrointestinal System--Abnormalities
Keywords: Enteral Nutrition
Heat Application
Gastrointestinal System Functions
Continuous Enteral Nutrition
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gastric residual volume
timeFrame: 7 days
measure: Abdominal Distension
timeFrame: 7 days
measure: Bowel sounds
timeFrame: 7 days
Secondary outcomes:
measure: Defecation Patterns
timeFrame: 7 days
measure: Vomiting
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.