"The Effect of Abdominal Massage on Gastrointestinal Functions in Mechanically Ventilated Patients Receiving Enteral Nutrition in Intensive Care"

NCT06631001 | Recruiting

• 1 other identifier: MersinU2024-AMGF
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of abdominal massage on gastrointestinal functions in mechanically ventilated patients receiving enteral nutrition in intensive care units.

Conditions

Defecation Disorder; Gastrointestinal Motility Disorder; Gastrointestinal Motility and Defecation Conditions

Keywords

Abdominal massage; Gastrointestinal Motility and Defecation Conditions; Gastrointestinal Motility; Intensive care; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• Bowel Movements: This measure will assess the frequency of defecation during the intervention period.

  he frequency of bowel movements will be recorded to assess gastrointestinal function, where increased frequency is considered a positive outcome.

  Measured twice daily (morning and evening) over 3 days.

Secondary Outcomes (1)

• This measure will be used to determine the amount of stomach content remaining after feeding.

  Measured twice daily (morning and evening) over 3 days.

Other Outcomes (1)

• This measure will be used to determine abdominal distension after feeding.

  Measured twice daily (morning and evening) over 3 days.

Study Arms (2)

Abdominal Massage Group

EXPERIMENTAL

This group consists of patients receiving abdominal massage. Abdominal massage will be administered twice a day for 15 minutes. This intervention is conducted to assess its effects on defecation frequency, gastric residual volume, and abdominal distension.

Other: Abdominal Massage

Control Group

NO INTERVENTION

This group will receive standard care without abdominal massage. Measurements for bowel excretion frequency, gastric residual volume, and abdominal distension will also be conducted.

Interventions

Abdominal Massage OTHER

Abdominal massage will be administered twice a day for 15 minutes over three days. This intervention aims to evaluate its effects on defecation frequency, gastric residual volume, and abdominal distension.

Abdominal Massage Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age.
• Patients who have been intubated and are on enteral feeding for at least 5 days.
• Patients without wounds on the extremities or abdominal area.
• Patients without a history of surgical intervention or radiotherapy in the abdominal area.
• Patients without current gastrointestinal symptoms (constipation, diarrhea, vomiting, abdominal distension, or increased gastric residual volume).
• Patients without intestinal obstruction.
• Patients who have given consent through a first-degree relative.
• Patients with no contraindications for abdominal massage.
• Glasgow Coma Scale GCS \> 3.
• Acute Physiology and Chronic Health Evaluation (APACHE II) score \> 16

You may not qualify if:

• Patients receiving intermittent enteral nutrition
• Patients not on mechanical ventilation
• Patients with contraindications for abdominal massage
• Patients fed via Percutaneous Endoscopic Gastrostomy
• Patients who were intubated later
• Patients hospitalized due to postoperative reasons

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin Toros State Hospital

Mersin, 33010, Turkey (Türkiye)

RECRUITING

Related Publications (32)

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Central Study Contacts

Yusuf Yüce

CONTACT

533 096 43 21; yceyusuf0@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is single-blind, meaning that participants are unaware of whether they are in the intervention or control group, while care providers and investigators have access to this information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student nurse

Model Details: Participants are randomly assigned to either the intervention group receiving abdominal massage or the control group

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: January 6, 2025
• Primary Completion: June 27, 2025
• Study Completion: August 29, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)