- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824857
Effect of Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage (Massage)
August 20, 2025 updated by: Zühal Erdoğan, Gazi University
Effect of Postoperative Abdominal Massage on Bowel Movements in Patients With Subarachnoid Hemorrhage
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.
The sample of the study will consist of a total of 64 patients, 32 in the experimental group and 32 in the control group, hospitalized in the tertiary neurosurgery intensive care unit.
Data collection tools are the "Descriptive Characteristics Form" and the "Patient Follow-up Form".The statistician will determine whether the patients who meet the sampling criteria will be assigned to the experimental or control group through randomization.
The stratified randomization method will be used in the study.
In this context, patients who meet the inclusion criteria from the start date of the study in the Neurosurgery Intensive Care Unit will be randomized by assigning them to the control group and abdominal massage groups, respectively.
Patients will be assigned to the control and abdominal massage groups in this order until the sample size is reached.
The CONSORT diagram will be used in the randomization of patients.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Gazi University
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Ankara, Turkey, 06490
- Faculty of Nursing, Gazi University
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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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• 18 years of age or older
- Underwent neurovascular surgery
- Received general anesthesia
- Have no wounds, surgical intervention, or radiotherapy in the abdominal region
- Have no bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, abdominal herniation, or bowel cancer
- Began oral feeding at the 6th hour post-surgery
- Stayed in the intensive care unit for 3 or more days
- Have a Glasgow Coma Scale (GCS) score of 9 or above
- Have no signs of acute abdomen
- Have no intra-abdominal infection
- No mechanical ventilation
- Mobilezed in the preoperative period
- Unable to mobilize after surgery
- Evaluated by the intensive care physician with no contraindications for abdominal massage
- Have a first-degree relative who has given consent
Exclusion Criteria:
Patients with the following conditions will be excluded from the sample:
- Those with chronic constipation, fecal incontinence, or diarrhea
- Those fed with a fiber-enriched nutritional solution (e.g., Nutrison Protein Plus Multifibre®, Fresubin Original Fibre®, Isosource Fiber®, Jevity Plus®)
- Those fed via nasogastric enteral tube
- Those receiving parenteral nutrition
- Patients with a BMI > 40 (morbid obesity)
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Abdominal Massage Application Group
After explaining the purpose of the study to the relatives of patients in the abdominal massage group, the "Introductory Characteristics Form" will be filled out.
Abdominal massage will be performed according to the Checklist at the 6th hour after surgery and at the same times in the morning and evening for the first 3 days post-surgery.
Before and 15 minutes after the abdominal massage application, bowel sounds will be auscultated, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed and recorded in the patient follow-up form.
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As part of the abdominal massage application, patient follow-up forms and checklists were prepared.
Before starting the study, the abdominal massage practitioner participated in a certification program on this topic and received a competency certificate.
Patients will be followed up for the first 3 days postoperatively using the prepared patient follow-up forms.
Abdominal massage will be applied to each patient for 15 minutes according to a certain standard as stated in the literature
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No Intervention: Control Group
After explaining the purpose of the study to the relatives of patients in the control group, the "Introductory Characteristics Form" will be filled out.
At the same times as the experimental group, bowel sounds will be auscultated in the control group without any intervention, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time To Defecate
Time Frame: From the 6th hour after surgery until the end of the 3rd day after surgery
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Time of first defecation
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From the 6th hour after surgery until the end of the 3rd day after surgery
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Bowel Sounds
Time Frame: From the 6th hour after surgery until the end of the 3rd day after surgery
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Frequency of bowel sounds heard per minute
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From the 6th hour after surgery until the end of the 3rd day after surgery
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Abdominal Distension
Time Frame: From the 6th hour after surgery until the end of the 3rd day after surgery
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To be assessed by measuring the abdominal circumference with a tape measure
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From the 6th hour after surgery until the end of the 3rd day after surgery
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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)
September 16, 2024
Primary Completion (Actual)
March 20, 2025
Study Completion (Actual)
March 20, 2025
Study Registration Dates
First Submitted
October 11, 2024
First Submitted That Met QC Criteria
February 8, 2025
First Posted (Actual)
February 13, 2025
Study Record Updates
Last Update Posted (Actual)
August 21, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024 - 306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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