- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344532
Effect of Preoperative Abdominal Effleurage on Postoperative Constipation
The Effect of Preoperative Abdominal Superficial Effleurage Training on the Development of Postoperative Constipation in Patients Undergoing Abdominal Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative constipation is a common complication following abdominal surgery and may negatively affect patient comfort, recovery, and quality of life. Non-pharmacological nursing interventions that support bowel motility are therefore of increasing interest in perioperative care. Abdominal superficial effleurage is a gentle massage technique applied to the abdominal surface and is thought to stimulate intestinal peristalsis and promote bowel function.
This prospective, randomized controlled study will be conducted with patients scheduled to undergo abdominal surgery. A total of 42 patients will be randomly assigned to either the intervention group (n=21) or the control group (n=21) using a computer-generated randomization method. Patients in the intervention group will receive preoperative training on abdominal superficial effleurage in addition to routine clinical care, while patients in the control group will receive routine clinical care only. To minimize interaction between groups, data from the control group will be collected prior to the intervention group.
Abdominal superficial effleurage will be taught during the preoperative period and performed by patients postoperatively. The technique involves gentle stroking movements starting from the right upper quadrant of the abdomen and progressing toward the left lower quadrant. Each session will last approximately five minutes and will be performed one to three times daily during periods when the patient is not experiencing pain. Postoperative constipation will be evaluated on the 10th postoperative day through a telephone interview using the Bristol Stool Form Scale. Study data will be analyzed using appropriate descriptive and inferential statistical methods.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Ozkeskin, Associate Professor
- Phone Number: +90 505 663 18 33
- Email: mehmet.ozkeskin76@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled to undergo abdominal surgery
- Patients who are able to communicate verbally
- Patients who agree to participate in the study and provide written informed consent
Exclusion Criteria:
- Patients with preoperative constipation
- Patients with known gastrointestinal diseases affecting bowel motility
- Patients who are unable to perform abdominal superficial effleurage
- Patients with cognitive impairment or communication difficulties
- Patients who refuse to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Abdominal Superficial Effleurage Group
Participants in this group will receive preoperative training on abdominal superficial effleurage in addition to routine clinical care.
Following surgery, patients will perform the effleurage technique for approximately five minutes, one to three times daily, during periods without pain.
|
Abdominal superficial effleurage is a gentle abdominal massage technique involving stroking movements from the right upper quadrant toward the left lower quadrant of the abdomen.
Participants will be trained preoperatively to perform the technique, which will take approximately five minutes per session and will be performed one to three times daily postoperatively during pain-free periods.
|
|
No Intervention: Control Group
Participants in the control group will receive routine clinical care only and will not receive abdominal superficial effleurage training during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Constipation
Time Frame: 10 days postoperatively
|
Postoperative constipation will be assessed using the Bristol Stool Form Scale through a telephone interview conducted on the 10th postoperative day.
Stool types 1 and 2 will be considered indicative of constipation.
|
10 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool Consistency
Time Frame: 10 days postoperatively
|
Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS), a 7-point validated scale ranging from Type 1 (separate hard lumps, indicating severe constipation) to Type 7 (watery, no solid pieces, indicating severe diarrhea).
Higher scores indicate looser stool consistency and a tendency toward diarrhea.
|
10 days postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Ozkeskin, PhD, Ege University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOzkeskin7126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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