The Effect of Hot Water Foot Bath on Pain and Gas Release After Laparoscopic Cholecystectomy: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Postoperative pain intensity at 3 hours after transfer to the ward (pre-intervention baseline)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Total dose of analgesic medication used within the first 24 hours postoperatively(0-24 hours after surgery)
- Age (years)(Baseline (upon study entry))
- Sex(Baseline (upon study entry))
- Body Mass Index (BMI)(Baseline (upon study entry))
- ASA Physical Status Classification(Baseline (upon study entry))
- Type of anesthesia(Baseline (upon study entry))
- Surgical duration(From skin incision to skin closure)
- Comorbidities(Baseline (upon study entry))
研究者
Cansu Mert
Lecturer
Fenerbahce University