Efficacy of Cognitive Behavioral Therapy Administered in Patients With Dyssynergic Defecation

March 18, 2026 updated by: Ayse Naz Kalem, Ankara Etlik City Hospital

An Evaluation of the Efficacy of Cognitive Behavioral Therapy Administered in Conjunction With Pelvic Floor Exercises in Patients With Dyssynergic Defecation

The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

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 Contact

  • Name: Ayse Naz Kalem Ozgen, Specialist
  • Phone Number: +90 0312 797 00 00
  • Email: kalemnaz@gmail.com

Study Locations

  • Turkey (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06010
        • Recruiting
        • Ankara Etlik City Hospital
        • Contact:
          • Ayse Naz Kalem Ozgen, Specialist
          • Phone Number: +90 0312 797 00 00
          • Email: kalemnaz@gmail.com

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:

  1. A history of constipation lasting longer than one year
  2. Chronic constipation as defined by the Rome IV criteria
  3. Being between the ages of 18 and 55
  4. Findings consistent with dyssynergic defecation on anorectal manometry and balloon defecography
  5. Exclusion of organic and metabolic causes of chronic constipation

Exclusion Criteria:

  1. Active bowel disease
  2. Presence of an active anal fissure
  3. History of major abdominal surgery
  4. Presence of a neurological disorder
  5. Presence of a serious psychiatric disorder
  6. Use of medications that cause constipation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pelvic floor rehabilitation
Patients in the first group will receive education on lifestyle changes, and a rehabilitation program consisting of 15 sessions of relaxation and Kegel exercises-held three days a week at the pelvic floor unit-will be planned.
Other: Pelvic floor rehabilitation
Relaxation and kegel exercises and biofeedback therapy
Experimental: Pelvic floor rehabilitation+cognitive behavioral therapy
In addition to these treatments, patients in the second group will receive a total of five sessions of cognitive-behavioral therapy from a certified psychologist specializing in the field, focusing on their current gastrointestinal issues rather than their personal histories.
Behavioral: Pelvic floor rehabilitation+cognitive behavioral therapy
Relaxation and kegel exercises, biofeedback therapy and cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wexner Constipation Score
Time Frame: first day of treatment and 5th week of treatment
first day of treatment and 5th week of treatment
Constipation Severity Scale
Time Frame: first day of treatment and 5th week of treatment
first day of treatment and 5th week of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Bristol Stool Chart
Time Frame: first day of treatment and 5th week of treatment
first day of treatment and 5th week of treatment
Beck Depression Scale
Time Frame: first day of treatment and 5th week of treatment
first day of treatment and 5th week of treatment

Collaborators and Investigators

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

Sponsor

Ankara Etlik City Hospital

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 (Estimated)

March 30, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AEŞH-EK-2025-314

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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