Colonoscopy PainFOOTBATH-COLNCT07636109
Effect of Foot Bath After Colonoscopy
A study testing Warm foot bath in people with Colonoscopy Pain and Abdominal Distension, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy Pain, Abdominal Distension
- What is being tested?
- Warm foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) scheduled for planned colonoscopy
- Able to speak and understand Turkish
- Provided written informed consent
Who cannot join
- Foot deformity and/or neurologic nerve damage
- Foot amputation
- Communication problems
- Chronic analgesic use
- Substance dependence
- Undergoing just upper endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonoscopy Pain, Abdominal Distension
- Being tested
- Warm foot bath
- Keywords
- Foot bath, Hydrotherapy, Warm water, Colonoscopy, Pain, Abdominal distension, Flatus
- Medical subject headings
- Pain, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm foot bathOther
Warm water foot bath (40-41°C) for 30 minutes applied after colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Foot bath | Experimental | Participants received a warm foot bath (40-41°C) for 30 minutes after colonoscopy, in addition to standard care. Receives: Other: Warm foot bath |
| Control Arm | No intervention | Participants received routine post-colonoscopy routine care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-colonoscopy pain intensity (VAS)
Pain intensity measured using a 0-10 visual analog scale (VAS); higher scores indicate greater pain.
Measured: 0, 15, and 30 minutes after colonoscopy
Secondary outcomes (1)
Post-colonoscopy abdominal distension (VAS)
Distension severity measured using a 0-10 VAS; higher scores indicate greater distension.
Measured: 0, 15, and 30 minutes after colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Apr 2024
- Primary completion2 May 2024
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN ÖZHANLI, Kocaeli University
- Investigators
- Yasemin Özhanlı, Assist. Prof, Principal investigator, Kocaeli UniversityHATİCE MERVE ALPTEKİN, Assist. Prof, Study chair, Kocaeli UniversitySEVAL ULUBAY, PhD, Study chair, SAMSUN HOSPITALENES ŞAHİN, Assoc. Prof., Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636109
- Sponsor's protocol ID
- KOU-FOOTBATH-COLON-2024
- Acronym
- FOOTBATH-COL
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned.
Publications
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.
PubMed 37863680
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Bath After Colonoscopy on Pain, Abdominal Distension, and Time to First Flatus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07636109
- Acronym / sponsor ID
- FOOTBATH-COL / KOU-FOOTBATH-COLON-2024
- Conditions
- Colonoscopy Pain, Abdominal Distension
- Keywords
- Foot bath, Hydrotherapy, Warm water, Colonoscopy, Pain, Abdominal distension, Flatus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Foot bath | Experimental | Other: Warm foot bathParticipants received a warm foot bath (40-41°C) for 30 minutes after colonoscopy, in addition to standard care. |
| Control Arm | No intervention | –Participants received routine post-colonoscopy routine care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) scheduled for planned colonoscopy
- Able to speak and understand Turkish
- Provided written informed consent
Key exclusion criteria (6 listed)
- Foot deformity and/or neurologic nerve damage
- Foot amputation
- Communication problems
- Chronic analgesic use
- Substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm foot bathWarm water foot bath (40-41°C) for 30 minutes applied after colonoscopy. | Other | Foot bath |
Primary outcome
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.
1 secondary outcome
Post-colonoscopy abdominal distension (VAS)
Time frame: 0, 15, and 30 minutes after colonoscopy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 37863680Uslu 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Özhanlı, Assist. Prof principal investigator
Kocaeli University
HATİCE MERVE ALPTEKİN, Assist. Prof study chair
Kocaeli University
SEVAL ULUBAY, PhD study chair
SAMSUN HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm foot bath in people with Colonoscopy Pain and Abdominal Distension, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-colonoscopy pain intensity (VAS) (time frame: 0, 15, and 30 minutes after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.