Heat Application on Gastrointestinal System Functions

Enteral Nutrition Clinical Trial

Official title:

The Effect of Heat Application on Gastrointestinal System Functions in Patients Receiving Continuous Enteral Nutrition

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225687
• Other study ID #: HeatAppGastro
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: TC Erciyes University
• Contact: Özlem Ceyahn
• Phone: +903522076666
• Email: ozlemg[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Enteral Nutrition
• Gastrointestinal System--Abnormalities

Intervention

Other:
• Heat Application
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric residual volume	GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.	7 days
Primary	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
Primary	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	Defecation Patterns	measure defecation frequency and nature	7 days
Secondary	Vomiting	The number of vomitings during the day is recorded	7 days