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| Name | Class |
|---|---|
| Istanbul University - Cerrahpasa | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hot water foot bath | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-24 hours after surgery |
| Age (years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cansu Mert, RN, MSc. | Contact | +905365954172 | ozkan.karadede@iuc.edu.tr | |
| Yasemin Özhanlı, RN, PhD. | Contact | yaseminozhanli@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Hospital | Istanbul | 34098 | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
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The outcomes assessor responsible for recording postoperative pain levels and time to first flatus will be blinded to group allocation in order to reduce measurement bias. Participants and care providers cannot be blinded due to the nature of the intervention.
Participant age will be recorded from medical records in years. |
| Baseline (upon study entry) |
| Sex | Participant sex (male/female) will be recorded. | Baseline (upon study entry) |
| Body Mass Index (BMI) | BMI will be calculated based on weight (kg) and height (m) and recorded as kg/m². | Baseline (upon study entry) |
| ASA Physical Status Classification | ASA physical status classification will be noted from the preoperative anesthesia evaluation | Baseline (upon study entry) |
| Type of anesthesia | Type of anesthesia administered (general/regional) will be recorded. | Baseline (upon study entry) |
| Surgical duration | Duration of the surgical procedure (in minutes) will be recorded. | From skin incision to skin closure |
| Comorbidities | Pre-existing comorbid conditions will be documented using structured data form. | Baseline (upon study entry) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |