Effect of Foot Bath After Colonoscopy (FOOTBATH-COL)

June 3, 2026 updated by: YASEMİN ÖZHANLI, Kocaeli University

Effect of Foot Bath After Colonoscopy on Pain, Abdominal Distension, and Time to First Flatus: A Randomized Controlled Trial

This randomized controlled trial evaluated whether a 30-minute foot bath with warm water (40-41°C) after colonoscopy reduces post-procedure pain and abdominal distension and shortens the time to first passage of flatus. Ninety adults undergoing planned colonoscopy were randomized to a foot bath group or standard care. Pain and distension were assessed using a visual analog scale at 0, 15, and 30 minutes after the procedure. Time to first flatus and overall satisfaction were also recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants (n=90) were randomized 1:1 to receive a warm foot bath (40-41°C for 30 minutes) immediately after colonoscopy or to receive standard care only. Outcomes included post-colonoscopy pain and abdominal distension measured with a 0-10 VAS at 0, 15, and 30 minutes; time to first flatus recorded in minutes based on participant report; and overall satisfaction measured using VAS at the end of the observation period. The study was conducted in a university hospital endoscopy unit between April 2024 and December 2025.

Study Type

Interventional

Enrollment (Actual)

90

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

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (≥18 years) scheduled for planned colonoscopy
  • Able to speak and understand Turkish
  • Provided written informed consent

Exclusion Criteria:

  • Foot deformity and/or neurologic nerve damage
  • Foot amputation
  • Communication problems
  • Chronic analgesic use
  • Substance dependence
  • Undergoing just upper endoscopy

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot bath
Participants received a warm foot bath (40-41°C) for 30 minutes after colonoscopy, in addition to standard care.
Other: Warm foot bath
Warm water foot bath (40-41°C) for 30 minutes applied after colonoscopy.
No Intervention: Control Arm
Participants received routine post-colonoscopy routine care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-colonoscopy pain intensity (VAS)
Time Frame: 0, 15, and 30 minutes after colonoscopy
Pain intensity measured using a 0-10 visual analog scale (VAS); higher scores indicate greater pain.
0, 15, and 30 minutes after colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-colonoscopy abdominal distension (VAS)
Time Frame: 0, 15, and 30 minutes after colonoscopy.
Distension severity measured using a 0-10 VAS; higher scores indicate greater distension.
0, 15, and 30 minutes after colonoscopy.

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Yasemin Özhanlı, Assist. Prof, Kocaeli University
  • Study Chair: HATİCE MERVE ALPTEKİN, Assist. Prof, Kocaeli University
  • Study Chair: SEVAL ULUBAY, PhD, SAMSUN HOSPITAL
  • Study Chair: ENES ŞAHİN, Assoc. Prof., Kocaeli University

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

Helpful Links

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)

April 1, 2024

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

December 28, 2025

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU-FOOTBATH-COLON-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planned.

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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