Gastrointestinal Motility, Laparoscopic Cholecystectomy, Nursing Interventions, Postoperative Pain, Postoperative Recovery
Conditions
Keywords
foot bath, gas release, pain management, complementary therapy, nursing, cholesistectomy
Brief 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. 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.
Interventions
BEHAVIORALHot water foot bath
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.
Sponsors
Istanbul University - Cerrahpasa
Cansu Mert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASA Physical Status Classification | Baseline (upon study entry) | ASA physical status classification will be noted from the preoperative anesthesia evaluation |
| Type of anesthesia | Baseline (upon study entry) | Type of anesthesia administered (general/regional) will be recorded. |
| Total dose of analgesic medication used within the first 24 hours postoperatively | 0-24 hours after surgery | Total amount of analgesics (e.g., paracetamol, NSAIDs, opioids) administered and/or requested will be recorded from medical records. |
| Comorbidities | Baseline (upon study entry) | Pre-existing comorbid conditions will be documented using structured data form. |
| Surgical duration | From skin incision to skin closure | Duration of the surgical procedure (in minutes) will be recorded. |
| Age (years) | Baseline (upon study entry) | Participant age will be recorded from medical records in years. |
| Sex | Baseline (upon study entry) | Participant sex (male/female) will be recorded. |
| Body Mass Index (BMI) | Baseline (upon study entry) | BMI will be calculated based on weight (kg) and height (m) and recorded as kg/m². |
Countries
Turkey (Türkiye)
Contacts
Primary ContactCansu Mert, RN, MSc.
Backup ContactYasemin Özhanlı, RN, PhD.
Outcome results
None listed