- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373772
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
16 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.
|
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
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
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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