NCT06237725

Brief Summary

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.

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
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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 25, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

November 25, 2023

Last Update Submit

January 25, 2024

Conditions

Enteral NutritionGastrointestinal System--Abnormalities

Keywords

Enteral NutritionContinuous and Bolus InfusionAbdominal MassageGastrointestinal System Function

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 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

    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 Outcomes (2)

  • Defecation patterns

    7 days

  • Vomiting

    7 days

Study Arms (4)

Nutrition of Continuous

EXPERIMENTAL

Experimental: Intervention Group to Nutrition of Continuous

Other: Nutrition of Continuous

Control Group Nutrition of Continuous

NO INTERVENTION

Control Group to Nutrition of Continuous

Nutrition of Bolus

EXPERIMENTAL

Experimental: Intervention Group to Nutrition of Bolus

Other: Nutrition of Bolus

Control Group Nutrition of Bolus

NO INTERVENTION

Control Group to Nutrition of Bolus

Interventions

Nutrition of ContinuousOTHER

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.

Nutrition of Continuous
Nutrition of BolusOTHER

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.

Nutrition of Bolus

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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

  • Wang X, Sun J, Li Z, Luo H, Zhao M, Li Z, Li Q. Impact of abdominal massage on enteral nutrition complications in adult critically ill patients: A systematic review and meta-analysis. Complement Ther Med. 2022 Mar;64:102796. doi: 10.1016/j.ctim.2021.102796. Epub 2021 Dec 10.

    PMID: 34902566BACKGROUND

  • Dehghan M, Malakoutikhah A, Ghaedi Heidari F, Zakeri MA. The Effect of Abdominal Massage on Gastrointestinal Functions: a Systematic Review. Complement Ther Med. 2020 Nov;54:102553. doi: 10.1016/j.ctim.2020.102553. Epub 2020 Sep 12.

    PMID: 33183670BACKGROUND

  • Cetinkaya O, Ovayolu O, Ovayolu N. The Effect of Abdominal Massage on Enteral Complications in Geriatric Patients. SAGE Open Nurs. 2020 Oct 13;6:2377960820963772. doi: 10.1177/2377960820963772. eCollection 2020 Jan-Dec.

    PMID: 35155761BACKGROUND

  • 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

Central Study Contacts

Özlem Ceyhan

CONTACT

+9035220766ozlemg@erciyes.edu.tr

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 25, 2023

First Posted

February 1, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

November 1, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01