Laparoscopic CholecystectomyNCT07126223
Hot Water Foot Bath for Pain and Gas Relief After Laparoscopic Cholecystectomy
A study testing Hot water foot bath in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Cansu Mert at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of a hot foot bath on postoperative pain and time to first gas release in patients undergoing laparoscopic cholecystectomy. The intervention is a non-pharmacological supportive method applied during the early postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain, Gastrointestinal Motility
- What is being tested?
- Hot water foot bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Undergoing elective laparoscopic cholecystectomy
- Received the same preoperative gastrointestinal preparation protocol
- Received the same postoperative analgesia protocol
- Numeric Rating Scale (NRS) pain score of 3 or higher at the 3rd postoperative hour
- Voluntarily agreed to participate and signed the informed consent form
- Classified as ASA I or ASA II according to the American Society of Anesthesiologists (ASA)
Who cannot join
- Undergoing emergency cholecystectomy or open surgery (laparotomy)
- Presence of open wounds, infections, circulatory disorders, or lesions in the feet (hot foot bath area)
- Use of patient-controlled analgesia (PCA) in the early postoperative period
- Any condition that impairs verbal communication
- History of inflammatory bowel disease (due to potential influence on bowel motility)
- Use of medications or probiotic agents affecting bowel motility in the pre- or postoperative period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasemin Özhanlı, RN, PhD. contact
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital
Istanbul, 34098
Özkan Karadede, RN, MSc., +905067705766, ozkan.karadede@iuc.edu.tr
Cansu Mert, RN, MSc., +905365954172, cansu.mert@fbu.edu.tr
About this study
Official title: The Effect of Hot Water Foot Bath on Pain and Gas Release After Laparoscopic Cholecystectomy: A Randomised Controlled Trial
This study investigates the effects of a hot foot bath on postoperative pain and time to first gas release in patients undergoing laparoscopic cholecystectomy. The intervention is a non-pharmacological supportive method applied during the early postoperative period. Participants will be randomly assigned to either intervention or control groups. No FDA-regulated drug or device is involved.
Read the detailed description
This randomised controlled clinical trial aims to evaluate the effects of hot foot bath therapy on postoperative pain and time to first flatus in patients undergoing laparoscopic cholecystectomy. The hot water foot bath is a non-pharmacological, supportive intervention to be administered at 3 hours postoperatively after patients have regained consciousness and are clinically stable.
Participants will be randomly divided into two groups: the intervention group will receive a 20-minute foot bath at a water temperature of 41°C, while the control group will receive standard postoperative care without a foot bath. The primary outcomes include pain level assessed using the Numerical Rating Scale (NRS) and time to first flatus recorded in hours postoperatively.
In addition to these primary outcomes, the study will also collect data through a two-part questionnaire. The first part will include questions regarding the sociodemographic and medical history of the patients, such as age, gender, marital status, education level, income level, presence of chronic diseases, previous surgical history, preoperative bowel movement frequency and duration of surgery. The second part focuses on indicators of postoperative recovery, including time to surgery, time to postoperative ward arrival, time to first oral intake, time to first mobilisation, total mobilisation time in the first 8 hours, time to first gas passage and type of analgesic administered.
This study does not involve any drug or device regulated by the U.S. Food and Drug Administration (FDA). Ethical approval was obtained from the Fenerbahçe University Non-Interventional Research Ethics Committee. Institutional permission was also granted in writing by Istanbul University-Cerrahpaşa Faculty of Medicine Hospital, where the clinical study will be conducted. No funding was received from Fenerbahçe University or any other organization.
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain, Gastrointestinal Motility, Postoperative Recovery, Nursing Interventions
- Being tested
- Hot water foot bath
- Keywords
- foot bath, gas release, pain management, complementary therapy, nursing, cholesistectomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot water foot bathBehavioural
A 20-minute hot foot bath therapy using a specially designed foot spa device (41°C) applied in the early postoperative period. Follow-up includes pain evaluation via Numeric Rating Scale (NRS) and monitoring of first flatus time.
| Study group | Role | What they receive |
|---|---|---|
| Hot water foot bath group | Experimental | Participants in this group will receive a 20-minute hot foot bath using a device with fixed temperature control (41°C), anti-slip base, timer, and vibration massage features. The intervention will be conducted 3 hours after postoperative transfer to the ward, once the patient is clinically stable. The room temperature will be maintained between 22°C and 25°C throughout the intervention. Participants will sit in a chair and immerse their feet in 41°C water for 20 minutes. Afterward, their feet will be wrapped in a towel for 10 minutes to retain heat. Pain levels (NRS) will be assessed immediately before the intervention, and again at 1 and 2 hours post-intervention (corresponding to 4h30 and 5h30 post-surgery). Time to first flatus will also be tracked using a monitoring form filled by patients or caregivers. Receives: Behavioral: Hot water foot bath |
| Standard postoperative care group | No intervention | Participants in this group will receive standard postoperative care without any foot bath intervention. Pain levels (NRS) will be evaluated at 3h30, 4h30, and 5h30 after surgery. Room temperature will be maintained between 22°C and 25°C. First gas passage time will be tracked using a monitoring form completed by the patient or caregiver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline)
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Measured: 3 hours after transfer to the ward
Postoperative pain intensity at 1 hour after the intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Measured: 1 hour after the intervention
Postoperative pain intensity at 2 hours after the intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Measured: 2 hours after the intervention
Time to first postoperative gas release
The time (in hours) from the end of surgery to the first postoperative gas release will be recorded. Patients or caregivers will use a monitoring form to document the exact time of gas passage, which will be confirmed by the research team during routine postoperative follow-up.
Measured: Up to 72 hours postoperatively
Secondary outcomes (8)
Total dose of analgesic medication used within the first 24 hours postoperatively
Total amount of analgesics (e.g., paracetamol, NSAIDs, opioids) administered and/or requested will be recorded from medical records.
Measured: 0-24 hours after surgery
Age (years)
Participant age will be recorded from medical records in years.
Measured: Baseline (upon study entry)
Sex
Participant sex (male/female) will be recorded.
Measured: Baseline (upon study entry)
Body Mass Index (BMI)
BMI will be calculated based on weight (kg) and height (m) and recorded as kg/m².
Measured: Baseline (upon study entry)
ASA Physical Status Classification
ASA physical status classification will be noted from the preoperative anesthesia evaluation
Measured: Baseline (upon study entry)
Type of anesthesia
Type of anesthesia administered (general/regional) will be recorded.
Measured: Baseline (upon study entry)
Surgical duration
Duration of the surgical procedure (in minutes) will be recorded.
Measured: From skin incision to skin closure
Comorbidities
Pre-existing comorbid conditions will be documented using structured data form.
Measured: Baseline (upon study entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start20 Dec 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: the intervention group receiving a hot foot bath and the control group receiving standard postoperative care. Both groups will be monitored concurrently without crossover throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cansu Mert
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Cansu Mert, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126223
- Sponsor's protocol ID
- 103.2024fbu
- Status last verified
- Dec 2025
- First submitted
- 23 Jul 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study does not include prior approval from the ethics committee or institutional policies for data sharing. Additionally, no data sharing was planned in the informed consent obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Water Foot Bath on Pain and Gas Release After Laparoscopic Cholecystectomy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07126223
- Acronym / sponsor ID
- 103.2024fbu
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Pain, Gastrointestinal Motility, Postoperative Recovery, Nursing Interventions
- Keywords
- foot bath, gas release, pain management, complementary therapy, nursing, cholesistectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cansu MertUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Aug 2025 (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 study investigates the effects of a hot foot bath on postoperative pain and time to first gas release in patients undergoing laparoscopic cholecystectomy. The intervention is a non-pharmacological supportive method applied during the early postoperative period. Participants will be randomly assigned to either intervention or control groups. No FDA-regulated drug or device is involved.
Detailed description
This randomised controlled clinical trial aims to evaluate the effects of hot foot bath therapy on postoperative pain and time to first flatus in patients undergoing laparoscopic cholecystectomy. The hot water foot bath is a non-pharmacological, supportive intervention to be administered at 3 hours postoperatively after patients have regained consciousness and are clinically stable.
Participants will be randomly divided into two groups: the intervention group will receive a 20-minute foot bath at a water temperature of 41°C, while the control group will receive standard postoperative care without a foot bath. The primary outcomes include pain level assessed using the Numerical Rating Scale (NRS) and time to first flatus recorded in hours postoperatively.
In addition to these primary outcomes, the study will also collect data through a two-part questionnaire. The first part will include questions regarding the sociodemographic and medical history of the patients, such as age, gender, marital status, education level, income level, presence of chronic diseases, previous surgical history, preoperative bowel movement frequency and duration of surgery. The second part focuses on indicators of postoperative recovery, including time to surgery, time to postoperative ward arrival, time to first oral intake, time to first mobilisation, total mobilisation time in the first 8 hours, time to first gas passage and type of analgesic administered.
This study does not involve any drug or device regulated by the U.S. Food and Drug Administration (FDA). Ethical approval was obtained from the Fenerbahçe University Non-Interventional Research Ethics Committee. Institutional permission was also granted in writing by Istanbul University-Cerrahpaşa Faculty of Medicine Hospital, where the clinical study will be conducted. No funding was received from Fenerbahçe University or any other organization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: the intervention group receiving a hot foot bath and the control group receiving standard postoperative care. Both groups will be monitored concurrently without crossover throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Hot water foot bath group | Experimental | Behavioral: Hot water foot bathParticipants in this group will receive a 20-minute hot foot bath using a device with fixed temperature control (41°C), anti-slip base, timer, and vibration massage features. The intervention will be conducted 3 hours after postoperative transfer to the ward, once the patient is clinically stable. The room temperature will be maintained between 22°C and 25°C throughout the intervention. Participants will sit in a chair and immerse their feet in 41°C water for 20 minutes. Afterward, their feet will be wrapped in a towel for 10 minutes to retain heat. Pain levels (NRS) will be assessed immediately before the intervention, and again at 1 and 2 hours post-intervention (corresponding to 4h30 and 5h30 post-surgery). Time to first flatus will also be tracked using a monitoring form filled by patients or caregivers. |
| Standard postoperative care group | No intervention | –Participants in this group will receive standard postoperative care without any foot bath intervention. Pain levels (NRS) will be evaluated at 3h30, 4h30, and 5h30 after surgery. Room temperature will be maintained between 22°C and 25°C. First gas passage time will be tracked using a monitoring form completed by the patient or caregiver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Undergoing elective laparoscopic cholecystectomy
- Received the same preoperative gastrointestinal preparation protocol
- Received the same postoperative analgesia protocol
- Numeric Rating Scale (NRS) pain score of 3 or higher at the 3rd postoperative hour
Key exclusion criteria (6 listed)
- Undergoing emergency cholecystectomy or open surgery (laparotomy)
- Presence of open wounds, infections, circulatory disorders, or lesions in the feet (hot foot bath area)
- Use of patient-controlled analgesia (PCA) in the early postoperative period
- Any condition that impairs verbal communication
- History of inflammatory bowel disease (due to potential influence on bowel motility)
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 |
|---|---|---|
| Hot water foot bathA 20-minute hot foot bath therapy using a specially designed foot spa device (41°C) applied in the early postoperative period. Follow-up includes pain evaluation via Numeric Rating Scale (NRS) and monitoring of first flatus time. | Behavioural | Hot water foot bath group |
Primary outcome
Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline)
Time frame: 3 hours after transfer to the ward
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Postoperative pain intensity at 1 hour after the intervention
Time frame: 1 hour after the intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Postoperative pain intensity at 2 hours after the intervention
Time frame: 2 hours after the intervention
Pain intensity will be assessed using the 11-point Numeric Rating Scale (0 = no pain, 10 = worst pain imaginable). Higher scores indicate worse outcomes.
Time to first postoperative gas release
Time frame: Up to 72 hours postoperatively
The time (in hours) from the end of surgery to the first postoperative gas release will be recorded. Patients or caregivers will use a monitoring form to document the exact time of gas passage, which will be confirmed by the research team during routine postoperative follow-up.
8 secondary outcomes
Total dose of analgesic medication used within the first 24 hours postoperatively
Time frame: 0-24 hours after surgery
Age (years)
Time frame: Baseline (upon study entry)
Sex
Time frame: Baseline (upon study entry)
Body Mass Index (BMI)
Time frame: Baseline (upon study entry)
ASA Physical Status Classification
Time frame: Baseline (upon study entry)
Type of anesthesia
Time frame: Baseline (upon study entry)
Surgical duration
Time frame: From skin incision to skin closure
Comorbidities
Time frame: Baseline (upon study entry)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study does not include prior approval from the ethics committee or institutional policies for data sharing. Additionally, no data sharing was planned in the informed consent obtained from participants.
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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.
Yasemin Özhanlı, RN, PhD. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot water foot bath in people with Laparoscopic Cholecystectomy and Postoperative Pain, run by Cansu Mert 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 7 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: opening soon, as of the sponsor's last update on 5 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu Mert, RN, MSc. (+905365954172, ozkan.karadede@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline) (time frame: 3 hours after transfer to the ward). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.