Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery

April 30, 2020 updated by: Gulay ALTUN UGRAS, Mersin University

The Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery: A Randomized Controlled Trial

Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent CS. The patients were randomly assigned (1:1) to the AM and control groups. The constipation risk of all the patients following CS was assessed with Constipation Risk Assessment Scale (CRAS). Those patients in the AM group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. The bowel sounds of all the patients in the AM and control groups were assessed on a daily basis. The days when bowel sounds were heard and the first defecation took place were recorded in a Bowel Evacuation Form.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Patients who

  • volunteered to participate in the study,
  • were 18 years old or older and underwent CS,
  • stayed in the ICU for ≥ 3 days,

Exclusion Criteria: Patients who

  • have percutaneous endoscopic gastrostomy,
  • abdominal hernia,
  • irritable bowel syndrome
  • bowel cancer,
  • history of abdominal surgery,
  • pregnancy,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: abdominal massage group
the abdominal massage group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation.
Other: abdominal massage
the patients in the AM group were given a total of 30 minutes of AM by the nurses (HD, OM) everyday for 15 minutes in the morning and evening.In this study AM, which included effleurage, strokes, petrissage and vibration techniques, was applied to the patients for 15 minutes in each session at 9:00 am and 9:00 pm.
No Intervention: control group
Routine care for the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primery outcome: bowel sounds
Time Frame: up to 10 days
time return of bowel sounds
up to 10 days
Primery outcome: first defecation
Time Frame: up to 10 days
time of the first defecation
up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
constipation risk
Time Frame: up to 24 hours
constipation risk in intensive care unit
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

February 28, 2016

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mersin U

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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