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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Ankara, Turkey
        • Gazi University
      • Ankara, Turkey, 06490
        • Faculty of Nursing, Gazi University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Abdominal Massage Application
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time To Defecate
Time Frame: From the 6th hour after surgery until the end of the 3rd day after surgery
Time of first defecation
From the 6th hour after surgery until the end of the 3rd day after surgery
Bowel Sounds
Time Frame: From the 6th hour after surgery until the end of the 3rd day after surgery
Frequency of bowel sounds heard per minute
From the 6th hour after surgery until the end of the 3rd day after surgery
Abdominal Distension
Time Frame: From the 6th hour after surgery until the end of the 3rd day after surgery
To be assessed by measuring the abdominal circumference with a tape measure
From the 6th hour after surgery until the end of the 3rd day after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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