NCT06225687

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

29 days

First QC Date

November 28, 2023

Last Update Submit

January 25, 2024

Conditions

Keywords

Enteral NutritionHeat ApplicationGastrointestinal System FunctionsContinuous Enteral Nutrition

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

EXPERIMENTAL

Heat will be applied to the abdominal/lumbar area for 15 minutes.

Other: Heat Application

Control Group

NO INTERVENTION

No 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.

Heat Application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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: 31710593BACKGROUND
  • 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.

    PMID: 36528462BACKGROUND
  • 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.

    PMID: 22472671BACKGROUND
  • 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.

    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