Pain, PostoperativeNCT07366567
Effect of Foot Bath on Pain, Sleep, and Comfort Levels After Abdominal Surgery
A study testing Foot bath device in people with Pain, Postoperative and Sleep, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of foot bath application on pain level, comfort and sleep quality in the postoperative period. H1: Foot baths have a postoperative pain-reducing effect. H2: Foot baths have a postoperative comfort-enhancing effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Sleep
- What is being tested?
- Foot bath device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to 30 Dec 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
- who are hospitalized in the General Surgery Clinic,
- are on day 0 of surgery,
- volunteer to participate in the study,
- have no neuropsychiatric diagnosis and are not taking antipsychotic medications,
- are over 18 years of age,
- accept random selection,
- and undergo abdominal surgery.
- For the experimental group, all patients with no infectious diseases (shingles, fungal infections, eczema, warts, calluses), local infections (abscesses, etc.), open lesions/wounds, scar tissue, edema, hematomas, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorders, varicose veins, osteoporosis, osteomyelitis, hepatitis, degenerative joint diseases, neuropathy due to diabetes, toe deformities, recent fractures, dislocations, or ruptures of muscle fibers, tendons, or ligaments will be included in the sample.
Who cannot join
- patients who underwent multiple simultaneous surgeries along with abdominal surgery,
- those with postoperative complications such as delirium,
- those who underwent reoperation,
- those with a pain score >7 because it could affect sleep levels,
- and those who received narcotic analgesics on postoperative day 0 due to pain will be excluded from the sample.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayşe Nur Aktaş, Reg. Nurse contact
Turkey (Türkiye)1 site
Trakya University Hospital
Edirne, Cahit Arf Boulevard, 22030
ZEYNEP KIZILCIK ÖZKAN, Assoc.Prof, +905056010101, zeynepozkan@trakya.edu.tr
About this study
Official title: Effect of Foot Bath on Pain, Sleep, and Comfort Levels After Abdominal Surgery: A Randomized Controlled Trial
The aim of this study was to investigate the effects of foot bath application on pain level, comfort and sleep quality in the postoperative period.
H1: Foot baths have a postoperative pain-reducing effect. H2: Foot baths have a postoperative comfort-enhancing effect. H3: Foot baths have a postoperative sleep-improving effect.
Read the detailed description
The research will be conducted with the participation of surgical patients who underwent abdominal surgery between December 2025 and December 2026 in the General Surgery Department of Tekirdag University Hospital.
Using the G*Power 3.1.9.4 program, the minimum number of people to be included in the sample was found to be 88 (44:44), assuming an effect size of 0.8 at a 95% confidence level and a 95% power ratio. To avoid the risk of sample loss, it was decided to include 48 patients in each group.
- Conditions
- Pain, Postoperative, Sleep
- Being tested
- Foot bath device
- Keywords
- pain, foot bath, sleep quality, comfort
- Medical subject headings
- Pain, Postoperative, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot bath deviceOther
On the day of surgery, patients will receive a foot bath between 9:00 PM and 10:00 PM. Any socks or clothing on both feet will be removed. The feet will be visually and manually examined to determine if they show any signs of illness (pressure ulcers, discoloration, wounds, etc.). The patient will be informed that the foot bath device is disinfected before each use and that water-tight bags will be placed around the device to prevent contact between the foot and the water to facilitate repeated use. The water temperature will be adjusted to 41-42°C using an infrared thermometer (non-contact digital thermometer). Both feet will be placed inside the foot bath device. The patient's feet will remain in the foot bath device for 20 minutes. After the foot bath, the patient's feet will be thoroughly dried with a towel, and the patient will be re-dressed in their existing socks or anti-embolic stockings. Any side effects/adverse reactions, etc., related to the foot bath will be questioned and
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (with Foot Bath Device Foot Bath Application (20 min, 41-42°C) | Experimental | Postoperative Preparation: The intervention will commence once the effects of anesthesia have subsided and initial mobilization (routinely 6-8 hours post-surgery) has been achieved. At approximately 9:00 PM, the patient's feet will be prepared by removing socks or adjusting anti-embolic stockings above the ankle . A visual and physical examination of the feet will be conducted to screen for contraindications such as pressure injuries, wounds, or discoloration.
Foot Bath Intervention: The foot bath procedure will be performed using a disinfected device lined with single-use, watertight bags to ensure hygiene.The water temperature will be strictly maintained at 41-42°C, verified by a non-contact infrared digital thermometer. Both feet will be immersed in the device for a duration of 20 minutes. Post-intervention, the researcher will thoroughly dry the patient's feet and replace their socks or anti-embolic stockings. Any adverse events or side effects observed, recorded. Receives: Other: Foot bath device |
| Control group Control group (Standard care (no foot bath procedure) | No intervention | Patients in the control group will receive routine care. Patient Recruitment and Preoperative Phase: Patients admitted to the General Surgery department for abdominal surgery will be informed about the study on the morning of their procedure. Following the acquisition of both verbal and written informed consent, the Patient Information Form will be completed. To establish a baseline for sleep quality, the Richards-Campbell Sleep Questionnaire (RCSQ) will be administered preoperatively. No foot bath application will be in question for the patients in the control group. Data Collection and Conclusion: On the morning of the first postoperative day, the RCSQ, GKO (Visual Analog Scale/Global Quality Scale), and pain scores will be administered to evaluate the intervention's impact. The data collection process will conclude following these assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
"Numerical rating scale" A score of 0 (zero) indicates no pain, while a score of 10 (ten) indicates unbearable pain.
Measured: postoperative period (first day)
sleep quality
"The Richards-Campbell Sleep Questionnaire" Each item is scored on a visual analog scale from 0 to 100. Scores between 0 and 25 indicate very poor sleep, while scores between 76 and 100 indicate very good sleep.
Measured: postoperative period (1st day)
Secondary outcomes (1)
Adverse effect
Adverse effect (Yes or No)
Measured: during application and 12 hours of application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start29 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Patients in the experimental group will receive a foot bath. Patients in the control group will not be intervened within the scope of the study.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Kızılcık Ozkan, Trakya University
- Investigators
- ZEYNEP KIZILCIK ÖZKAN, Assoc.Prof, Study chair, Trakya UniversityAyşe Nur Aktaş, Reg.Nurse, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366567
- Sponsor's protocol ID
- 2025/284
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While obtaining ethics committee approval, the application form included information that the data would only be used by researchers and would not be shared with third parties.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Bath on Pain, Sleep, and Comfort Levels After Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07366567
- Acronym / sponsor ID
- 2025/284
- Conditions
- Pain, Postoperative, Sleep
- Keywords
- pain, foot bath, sleep quality, comfort
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Jan 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.
The aim of this study was to investigate the effects of foot bath application on pain level, comfort and sleep quality in the postoperative period.
H1: Foot baths have a postoperative pain-reducing effect. H2: Foot baths have a postoperative comfort-enhancing effect. H3: Foot baths have a postoperative sleep-improving effect.
Detailed description
The research will be conducted with the participation of surgical patients who underwent abdominal surgery between December 2025 and December 2026 in the General Surgery Department of Tekirdag University Hospital.
Using the G*Power 3.1.9.4 program, the minimum number of people to be included in the sample was found to be 88 (44:44), assuming an effect size of 0.8 at a 95% confidence level and a 95% power ratio. To avoid the risk of sample loss, it was decided to include 48 patients in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the experimental group will receive a foot bath. Patients in the control group will not be intervened within the scope of the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group (with Foot Bath Device Foot Bath Application (20 min, 41-42°C) | Experimental | Other: Foot bath devicePostoperative Preparation: The intervention will commence once the effects of anesthesia have subsided and initial mobilization (routinely 6-8 hours post-surgery) has been achieved. At approximately 9:00 PM, the patient's feet will be prepared by removing socks or adjusting anti-embolic stockings above the ankle . A visual and physical examination of the feet will be conducted to screen for contraindications such as pressure injuries, wounds, or discoloration. Foot Bath Intervention: The foot bath procedure will be performed using a disinfected device lined with single-use, watertight bags to ensure hygiene.The water temperature will be strictly maintained at 41-42°C, verified by a non-contact infrared digital thermometer. Both feet will be immersed in the device for a duration of 20 minutes. Post-intervention, the researcher will thoroughly dry the patient's feet and replace their socks or anti-embolic stockings. Any adverse events or side effects observed, recorded. |
| Control group Control group (Standard care (no foot bath procedure) | No intervention | –Patients in the control group will receive routine care. Patient Recruitment and Preoperative Phase: Patients admitted to the General Surgery department for abdominal surgery will be informed about the study on the morning of their procedure. Following the acquisition of both verbal and written informed consent, the Patient Information Form will be completed. To establish a baseline for sleep quality, the Richards-Campbell Sleep Questionnaire (RCSQ) will be administered preoperatively. No foot bath application will be in question for the patients in the control group. Data Collection and Conclusion: On the morning of the first postoperative day, the RCSQ, GKO (Visual Analog Scale/Global Quality Scale), and pain scores will be administered to evaluate the intervention's impact. The data collection process will conclude following these assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- who are hospitalized in the General Surgery Clinic,
- are on day 0 of surgery,
- volunteer to participate in the study,
- have no neuropsychiatric diagnosis and are not taking antipsychotic medications,
- are over 18 years of age,
Key exclusion criteria (5 listed)
- patients who underwent multiple simultaneous surgeries along with abdominal surgery,
- those with postoperative complications such as delirium,
- those who underwent reoperation,
- those with a pain score >7 because it could affect sleep levels,
- and those who received narcotic analgesics on postoperative day 0 due to pain will be excluded from the sample.
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 |
|---|---|---|
| Foot bath deviceOn the day of surgery, patients will receive a foot bath between 9:00 PM and 10:00 PM. Any socks or clothing on both feet will be removed. The feet will be visually and manually examined to determine if they show any signs of illness (pressure ulcers, discoloration, wounds, etc.). The patient will be informed that the foot bath device is disinfected before each use and that water-tight bags will be placed around the device to prevent contact between the foot and the water to facilitate repeated use. The water temperature will be adjusted to 41-42°C using an infrared thermometer (non-contact digital thermometer). Both feet will be placed inside the foot bath device. The patient's feet will remain in the foot bath device for 20 minutes. After the foot bath, the patient's feet will be thoroughly dried with a towel, and the patient will be re-dressed in their existing socks or anti-embolic stockings. Any side effects/adverse reactions, etc., related to the foot bath will be questioned and | Other | Experimental group (with Foot Bath Device Foot Bath Application (20 min, 41-42°C) |
Primary outcome
Pain level
Time frame: postoperative period (first day)
"Numerical rating scale" A score of 0 (zero) indicates no pain, while a score of 10 (ten) indicates unbearable pain.
sleep quality
Time frame: postoperative period (1st day)
"The Richards-Campbell Sleep Questionnaire" Each item is scored on a visual analog scale from 0 to 100. Scores between 0 and 25 indicate very poor sleep, while scores between 76 and 100 indicate very good sleep.
1 secondary outcome
Adverse effect
Time frame: during application and 12 hours of application.
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 26 Jan 2026.
- Individual participant dataSharing planned: No. While obtaining ethics committee approval, the application form included information that the data would only be used by researchers and would not be shared with third parties.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Ayşe Nur Aktaş, Reg. Nurse contact
ZEYNEP KIZILCIK ÖZKAN, Assoc.Prof study chair
Trakya University
Ayşe Nur Aktaş, Reg.Nurse principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot bath device in people with Pain, Postoperative and Sleep, run by Trakya 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 8 inclusion and 5 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 26 Jan 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?
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 ZEYNEP KIZILCIK ÖZKAN, Assco.Prof (05056010101, zeynepozkan@trakya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: postoperative period (first day)). The study lists 2 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 26 Jan 2026.