NCT06075121

Brief Summary

This study will be conducted to determine the effect of abominal massage on feeding intolerance and blood sugar levels in intensive care patients who are continuously feeding enterally and have diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 12, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
Last Updated

January 20, 2025

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 27, 2023

Last Update Submit

January 17, 2025

Conditions

Keywords

massage

Outcome Measures

Primary Outcomes (4)

  • Gastric residual volume

    Gastric residual volume will be done every four hours. GRV measurement will be made 30 minutes after stopping feeding.

    5 days

  • Abdominal Distension

    Abdominal Distension be evaluated 30 minutes after stopping feeding. Abdominal distention control will be done using the palpation method.

    5 days

  • Bristol stool scale scale

    This scale is designed to classify an individual's bowel movements into seven separate categories of stool. According to the "Bristol Stool Consistency Scale", Type 1 and Type 2 indicate constipation, Type 3 and Type 4 indicate normal defecation, and Type 5, Type 6 and Type 7 indicate diarrhea.

    5 days

  • Blood sugar

    Blood glucose levels will be checked four times a day at 10:00-14:00-18:00 and 22:00.

    5 days

Study Arms (2)

Abdominal massage group

EXPERIMENTAL

Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening for 15 minutes.

Other: Abdominal massage

Control group

NO INTERVENTION

Routine treatment and care practices in the hospital will continue for 5 days without any additional intervention and the same data will be evaluated at the same time.

Interventions

Patients in the massage group will receive an abdominal massage twice a day for 5 days, between 10.00 in the morning and 22.00 in the evening. Enteral nutrition will be interrupted twice a day for 5 days, between 09.30-10.00 in the morning and 21.30-22.00 in the evening, and patients will receive an abdominal massage for 15 minutes.

Abdominal massage group

Eligibility Criteria

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

You may qualify if:

  • The age of 18 years and over
  • Diagnosed with diabetes mellitus
  • Having just started continuous enteral feeding via nasogastric tube
  • Glasgow coma scale \>3
  • Patients who do not have a wound in the abdominal area
  • Patients without current diarrhea, constipation, vomiting, abdominal distension
  • Patients who gave their consent to participate in the research

You may not qualify if:

  • Patients who had started enteral feeding before starting the study
  • Patients who received radiotherapy to the abdominal area
  • Abdominal surgery within the last three months
  • Patients with ileus
  • Patients using medications that affect gastrointestinal motility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya U

Amasya, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 10, 2023

Study Start

June 12, 2023

Primary Completion

June 22, 2024

Study Completion

June 22, 2024

Last Updated

January 20, 2025

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations