Heat Application on Gastrointestinal System Functions

NCT ID: NCT06225687

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteral Nutrition Gastrointestinal System--Abnormalities

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heat Application

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

Group Type EXPERIMENTAL

Heat Application

Intervention Type OTHER

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.

Control Group

No intervention will be made.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Özlem Ceyhan

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Özlem Ceyahn

Role: CONTACT

+903522076666 ext. 28561

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31710593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36528462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22472671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28746113 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HeatAppGastro

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.