NCT07636109

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

May 26, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Foot bathHydrotherapyWarm waterColonoscopyPainAbdominal distensionFlatus

Outcome Measures

Primary Outcomes (1)

  • Post-colonoscopy pain intensity (VAS)

    Pain intensity measured using a 0-10 visual analog scale (VAS); higher scores indicate greater pain.

    0, 15, and 30 minutes after colonoscopy

Secondary Outcomes (1)

  • Post-colonoscopy abdominal distension (VAS)

    0, 15, and 30 minutes after colonoscopy.

Study Arms (2)

Foot bath

EXPERIMENTAL

Participants received a warm foot bath (40-41°C) for 30 minutes after colonoscopy, in addition to standard care.

Other: Warm foot bath

Control Arm

NO INTERVENTION

Participants received routine post-colonoscopy routine care only.

Interventions

Warm water foot bath (40-41°C) for 30 minutes applied after colonoscopy.

Foot bath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

  • Uslu Y, Akbayrak H, Kuytak Ortahisar B, Barak TH. The effect of lavender foot baths on postoperative pain and sleep quality in comparison with foot baths with warm water only-A prospective randomized controlled study. Explore (NY). 2024 May-Jun;20(3):385-391. doi: 10.1016/j.explore.2023.10.003. Epub 2023 Oct 5.

    PMID: 37863680BACKGROUND

Related Links

MeSH Terms

Conditions

PainFlatulence

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Yasemin Özhanlı, Assist. Prof

    Kocaeli University

    PRINCIPAL INVESTIGATOR
  • HATİCE MERVE ALPTEKİN, Assist. Prof

    Kocaeli University

    STUDY CHAIR
  • SEVAL ULUBAY, PhD

    SAMSUN HOSPITAL

    STUDY CHAIR
  • ENES ŞAHİN, Assoc. Prof.

    Kocaeli University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 9, 2026

Study Start

April 1, 2024

Primary Completion

May 2, 2024

Study Completion

December 28, 2025

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Not planned.

Locations