Abdominal Massage in Enteral Nutrition Patients

January 25, 2024 updated by: Özlem Ceyhan, TC Erciyes University

The Effect of Abdominal Massage on Gastrointestinal System Functions in Patients Nutrition Enterally With Continuous and Bolus Infusion.

Complications related to the gastrointestinal system may arise in patients receiving enteral nutrition through continuous and bolus infusion. These complications include constipation, diarrhea, nausea, vomiting, abdominal distension, increased gastric residual volume, and abdominal pain. The aim of this study is to determine the impact of abdominal massage applied to patients receiving enteral nutrition through continuous or bolus infusion on gastrointestinal system functions. For this purpose, 164 patients meeting the inclusion criteria will be randomized, and four groups will be defined. Half will constitute the experimental group, and the others will form the control group. In our study, the effects of massage on symptom control will be evaluated by comparing symptoms in patients receiving both forms of nutrition. Thus, the evaluation and control of medical conditions (symptoms) such as constipation, diarrhea, vomiting, increased abdominal distension, and increased gastric residual volume are targeted.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients in intensive care
  • Those aged 18 and above
  • Patients being fed through a nasogastric tube
  • Patients on the first day of enteral nutrition
  • Patients without wounds in the abdominal region
  • Those who have not undergone abdominal surgery in the last 6 months
  • Patients not receiving radiotherapy/chemotherapy
  • Patients without a diagnosis of bowel obstruction
  • 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 abdominal massage (to be determined in consultation with the primary physician)

Exclusion Criteria:

  • Patients for whom enteral nutrition is discontinued during the study
  • Patients with interrupted enteral nutrition
  • Patients who have started prokinetic agents
  • The study will be terminated for patients who have started laxative medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition of Continuous
Experimental: Intervention Group to Nutrition of Continuous
Other: Nutrition of Continuous
The researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days.
No Intervention: Control Group Nutrition of Continuous
Control Group to Nutrition of Continuous
Experimental: Nutrition of Bolus
Experimental: Intervention Group to Nutrition of Bolus
Other: Nutrition of Bolus
The researcher will perform gastric residual volume (GRV) measurements with a syringe, abdominal circumference measurements, and distension assessments daily before starting enteral nutrition from the first day of initiation. They will also record vomiting/defecation frequency. Massage will be applied for 15 minutes. The same criteria will be measured and recorded. The application and measurements will be conducted twice a day for 10 consecutive days.
No Intervention: Control Group Nutrition of Bolus
Control Group to Nutrition of Bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric residual volume
Time Frame: 7 days
GRV measurement will be made 30 minutes after stopping feeding. It will be evaluated before and after application.
7 days
Abdominal Distension
Time Frame: 7 days
Abdominal distension will be evaluated 30 minutes after stopping feeding. The palpation method will be used. Additionally, the abdominal circumference will be measured with a tape measure. It will be evaluated before and after application.
7 days
Bowel sounds
Time Frame: 7 days
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 application.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defecation patterns
Time Frame: 7 days
measure defecation frequency and nature
7 days
Vomiting
Time Frame: 7 days
How many times the patient vomited during the day is recorded
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MassageGIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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