The Effect of Preoperative Abdominal Massage on Postoperative Constipation

May 5, 2026 updated by: Burcu Ozkan

The Effect of Preoperative Abdominal Massage on The Development of Postoperative Constipation: A Randomised Controlled Study

The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are:

• Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent constipation? To see if abdominal massage is effective in preventing constipation, researchers will not apply any treatment to the second group and will compare the two groups.

Participants will:

  • Provide researchers with information about their preoperative and postoperative stool consistency and constipation status.
  • Inform the researchers if the group that received the massage experiences any adverse effects from the massage.

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

Abdominal massage, being a low-cost, non-invasive procedure with no known harmful side effects, and one that nurses can integrate into clinical practice, plays an important role in the management of constipation.

This study is a single-center, randomized controlled experimental trial planned to be conducted in the General Surgery Department of a Training and Research Hospital in Istanbul. Standard operating procedures for patient recruitment, data collection, data management, adverse event reporting, and change management processes have been predefined. The experimental group will receive abdominal massage twice daily for 15 minutes, while the control group will continue with routine care. Adverse events will be recorded after each session, and necessary protocol changes will be documented in accordance with formal change management procedures. The sample size was determined based on a power analysis performed with G*Power 3.1; 30 participants were planned for each group (total n=60; α=0.05, power=0.80). A complete case analysis approach will be adopted for missing data resulting from data inconsistencies, out-of-range results, or unanswered items, and group assignments will continue until data is complete. In accordance with the statistical analysis plan, the Mann-Whitney U test will be used for between-group comparisons and the Wilcoxon test for within-group comparisons for the Bristol Stool Scale (BSS) score, which is the primary outcome measure; For the secondary outcome measure, stool type distribution, the Chi-square test will be applied. Effect size will be reported using Cohen's d and odds ratio, and the statistical significance threshold will be set at p<0.05.

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.
60

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 (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • Health Sciences University Sultan Abdülhamid Han Training and Research Hospital

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Being hospitalized in the General Surgery Department
  • Experiencing constipation
  • Being 18 years of age or older
  • Having the cognitive ability to answer questions
  • Voluntary participation in the study

Exclusion criteria:

  • Being under 18 years of age
  • Not experiencing constipation
  • Having a condition that contraindicates abdominal massage (active intra-abdominal pathology, open wound, thrombocytopenia, etc.)
  • Insufficient cognitive ability

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
No Intervention: Control Group
Experimental: Abdominal Massage İnterventional Group
Massage Group
Other: Abdominal Massage
The procedure will be followed using a protocol prepared by researchers based on a literature review. Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal. The massage duration is 15 minutes. The frequency of massage is twice a day. Necessary tools and equipment include liquid petroleum jelly and a towel. The massage techniques include effleurage (superficial and deep), petrissage, and vibration.

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
BSS score
Time Frame: BSS score preoperative period and postoperative 24. hour
According to the Bristol Stool Scale, a score of 1-2 indicates "hard stools," 3-4-5 indicates "normal stools," and 6-7 indicates "soft-watery stools (diarrhea)."
BSS score preoperative period and postoperative 24. hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stool type distribution/constipation
Time Frame: preoperative period and postoperative 24. hour
Stool type: hard/normal
preoperative period and postoperative 24. hour

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.
Burcu Ozkan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2026

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.
April 23, 2026

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.
April 23, 2026

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).
April 24, 2026

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.
April 29, 2026

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.
May 6, 2026

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.
May 8, 2026

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.
May 5, 2026

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.
April 1, 2026

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.
  • 24/11/2022-984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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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