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Clinical Trials/NCT07018414
NCT07018414CompletedNot Applicable

The Effect of Abdominal Massage on Gastric Residual Volume and Abdominal Distension in Surgical Intensive Care Patients: A Randomized Controlled Trial

Marmara University1 site in 1 country84 target enrollmentStarted: April 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
84
Locations
1
Primary Endpoint
Amount of gastric residual volume (mL)

Study Overview

Brief Summary

This randomized controlled trial aimed to evaluate the effect of abdominal massage on gastric residual volume (GRV) and abdominal distension in surgical intensive care patients receiving enteral nutrition. The intervention group received 20-minute abdominal massage sessions twice daily for 3 consecutive days. Outcomes included changes in GRV, abdominal circumference, feeding volume, and gastrointestinal tolerance parameters.

Detailed Description

Gastric residual volume (GRV) monitoring is commonly used in critically ill patients receiving enteral nutrition to assess gastrointestinal dysfunction, although current guidelines present conflicting recommendations regarding its necessity. Abdominal distension is a frequent complication during enteral feeding in surgical ICU patients. Non-pharmacological interventions such as abdominal massage have shown promise in improving gastrointestinal motility and enteral tolerance.

This study included 84 surgical ICU patients who met the inclusion criteria and were randomly assigned to intervention (n=42) and control (n=42) groups. The intervention group received abdominal massage twice daily for 20 minutes over three days. Data were collected using standardized forms and analyzed with appropriate statistical tests including independent samples t-test, Mann-Whitney U, repeated measures ANOVA, and chi-square tests. The findings suggest that abdominal massage may help stabilize GRV levels, reduce abdominal circumference, and increase nutritional intake without increasing complications.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Masking Description

This study was conducted as an open-label trial, with no masking of participants, healthcare providers, or outcome assessors. Due to the nature of the intervention (abdominal massage), blinding was not feasible. However, data collection and statistical analyses were performed by researchers not involved in delivering the intervention to minimize potential bias.

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age ≥ 18 years
  • •Receiving enteral nutrition via nasogastric tube
  • •No prior abdominal surgery
  • •No invasive devices (e.g., drains, catheters) in the abdominal area

Exclusion Criteria

  • •Receiving enteral nutrition via PEG or PEJ
  • •Receiving only parenteral nutrition
  • •History of abdominal surgery

Arms & Interventions

Abdominal Massage Group

Experimental

Patients in this group received abdominal massage for 20 minutes, twice daily, for three consecutive days after the initiation of enteral nutrition.

Intervention: Abdominal Massage (Behavioral)

Control Group

No Intervention

Patients in this group received standard postoperative care without abdominal massage.

Outcomes

Primary Outcomes

Amount of gastric residual volume (mL)

Time Frame: Day 3

Starting from the first day of enteral nutrition, gastric residual volume (mL) will be recorded at regular intervals every day for 3 days. The amount of GRV changing from the first day to the 3rd day will be measured and analysed.

Change in abdominal circumference

Time Frame: Day 3

Abdominal circumference will be measured on the first day of enteral feeding and abdominal circumference will be measured every day at the same time for 3 days. The change in abdominal circumference (cm) from baseline to Day 3 will be recorded.

Secondary Outcomes

  • Amount of enteral feeding (mL/day)(Day 3)
  • Assessment of abdominal distension(Day 3)
  • Interruption of enteral nutrition(Day 3)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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