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临床试验/NCT07417319
NCT07417319已完成不适用

Effects Of Nursing-Led Local Heat Application To The Feet On Postoperative Pain And Abdominal Distension After Cholecystectomy: A Randomised Controlled Trial

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年2月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
Abdominal Distension

研究概览

简要总结

This randomized controlled study aims to evaluate the effect of local heat application to the feet on postoperative pain and abdominal distension in patients undergoing open or laparoscopic cholecystectomy. Eligible participants will be randomly assigned to either a local heat application group or a control group. In the intervention group, heat will be applied to the feet using a hot-water bottle for 15 minutes at hourly intervals during the first four postoperative hours. Pain and abdominal distension will be assessed using validated scales, and gastrointestinal recovery indicators such as time to first flatus and defecation will be recorded. The study is designed to determine whether this simple, nurse-led, non-pharmacological intervention may improve postoperative comfort and recovery.

详细描述

Gallstone disease is a common health problem worldwide and represents a substantial clinical and economic burden. Cholecystectomy is among the most frequently performed abdominal surgical procedures, and postoperative symptoms such as pain and abdominal distension may delay mobilization, impair comfort, and prolong recovery. Postoperative ileus, characterized by temporary impairment of gastrointestinal motility, abdominal distension, and delayed passage of flatus or stool, is frequently observed following abdominal surgery.

Pharmacological analgesia, particularly opioid-based regimens, remains the standard approach for postoperative pain management; however, these medications may contribute to gastrointestinal dysmotility and delayed recovery. Therefore, non-pharmacological and nurse-led interventions are increasingly considered as complementary strategies to enhance patient outcomes and comfort. Approaches such as early mobilization, education, and sensory or physical modalities have been suggested to support recovery.

Local heat therapy is a simple, low-cost nursing intervention that may promote pain relief and physiological recovery through mechanisms including increased local circulation, muscle relaxation, and modulation of nociceptive pathways. Distal thermal applications, such as foot-based heat therapy, may influence autonomic regulation and gastrointestinal activity; however, evidence in patients undergoing cholecystectomy remains limited.

This study is designed as a single-blind randomized controlled trial to evaluate the effects of foot-based local heat application on postoperative pain, abdominal distension, and gastrointestinal recovery outcomes. Findings are expected to contribute to the evidence base for safe and feasible nursing interventions in postoperative care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had undergone laparoscopic cholecystectomy,
  • American Society of Anesthesiologists (ASA) physical status classification of I-II.

排除标准

  • Had any neurological or psychiatric disorders,
  • Conditions that could interfere with heat perception,
  • Contraindications to foot heat application,

研究组 & 干预措施

Local Heat Therapy Group

Experimental

Participants received local heat application to both feet using warm compresses/hot packs at 40-42°C for 15-20 minutes twice daily during the first 48 hours postoperatively in addition to standard nursing care and early mobilization. Postoperative pain intensity and abdominal distension were assessed at predetermined time points using validated measurement scales.

干预措施: Local Heat Application (Other)

结局指标

主要结局

Abdominal Distension

时间窗: At 6, 12, 24, and 48 hours postoperatively

Abdominal distension measured using the Abdominal Distension Scale (0-3) at 6, 12, 24, and 48 hours postoperatively.

Acute Postoperative Pain

时间窗: 6, 12, 24, and 48 hours postoperatively.

Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at 6, 12, 24, and 48 hours postoperatively.

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emel Tuğrul

Principal Investigator

Aydin Adnan Menderes University

研究点 (1)

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