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临床试验/NCT07363668
NCT07363668已完成不适用

Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy

Ataturk University1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
pain intensity (VAS score)

研究概览

简要总结

This randomized controlled study aims to evaluate the effects of aromatherapy foot massage on postoperative pain, sleep quality, and recovery in patients undergoing laparoscopic cholecystectomy.

详细描述

This study is a randomized controlled trial conducted in patients undergoing laparoscopic cholecystectomy. Eligible patients are randomly assigned to either an aromatherapy foot massage group or a control group receiving standard postoperative care.

In the intervention group, aromatherapy foot massage is applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later. The control group receives routine postoperative care without massage.

Pain intensity is assessed using the Visual Analog Scale (VAS). Sleep quality is assessed using the Visual Sleep Scale, and postoperative recovery is assessed using the Postoperative Recovery Index. Measurements are performed preoperatively and during the postoperative period according to the study protocol.

The study is conducted in accordance with ethical principles, and written informed consent is obtained from all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Adults aged 18 years and older
  • Patients undergoing laparoscopic cholecystectomy
  • Able to communicate and provide informed consent
  • Willing to participate in the study

排除标准

  • Patients with cognitive impairment or communication difficulties
  • Patients with chronic pain disorders
  • Patients using continuous analgesic or sedative medication
  • Patients with complications requiring intensive care
  • Patients who decline to participate

研究组 & 干预措施

Aromatherapy foot massage

Experimental

Patients receiving aromatherapy foot massage in addition to standard postoperative care

干预措施: aromatherapy foot massage (Other)

control

No Intervention

Patients receiving standard postoperative care without aromatherapy massage

结局指标

主要结局

pain intensity (VAS score)

时间窗: 5, 30, 60, 90, and 120 minutes after the massage session and on postoperative Day 1

Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

postoperative recovery (postoperative recovery ındex score)

时间窗: Baseline (preoperative) and postoperative Day 1

Postoperative recovery was assessed using the Postoperative Recovery Index (PRI), a validated questionnaire used to evaluate patients' recovery after surgery. Higher scores indicate better postoperative recovery.

次要结局

  • sleep quality (visual sleep scale score)(Baseline (preoperative) and postoperative Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ümmügülsüm Dursun

Msc

Ataturk University

研究点 (1)

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