NCT07018414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

May 23, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Enteral NutritionGastric EmptyingAbdominal DistensionIntensive Care Units, SurgicalPostoperative CareGastrointestinal Motility DisordersCritical IllnessMassage Therapy

Outcome Measures

Primary Outcomes (2)

  • Amount of gastric residual volume (mL)

    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.

    Day 3

  • Change in abdominal circumference

    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.

    Day 3

Secondary Outcomes (3)

  • Amount of enteral feeding (mL/day)

    Day 3

  • Assessment of abdominal distension

    Day 3

  • Interruption of enteral nutrition

    Day 3

Study Arms (2)

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.

Behavioral: Abdominal Massage

Control Group

NO INTERVENTION

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

Interventions

Non-pharmacological intervention involving manual massage of the abdomen to support gastric motility and reduce gastric residual volume and abdominal distension in enterally fed surgical ICU patients.

Abdominal Massage Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyrantepe Hamidiye Etfal Training and Research Hospital, Surgical Intensive Care Units

Istanbul, İ̇stanbul, 34230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study utilized a parallel assignment model, in which participants were randomly assigned to either the intervention group (receiving abdominal massage) or the control group (receiving standard care) in a 1:1 ratio. Each participant received only one type of intervention throughout the study period. The intervention was applied twice daily for 20 minutes over three consecutive days.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 12, 2025

Study Start

April 5, 2024

Primary Completion

April 5, 2025

Study Completion

April 5, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

This study does not plan to share individual participant data due to privacy concerns and institutional policy.

Locations