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临床试验/NCT05705908
NCT05705908已完成不适用

Effect of Foot Bath Using Warm Water and Lavender Essential Oil on Postoperative Sleep Quality and Pain: A Randomized Controlled Study

Acibadem University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
2
主要终点
Change between Post-operative Pain Score

研究概览

简要总结

One of the most common problems in patients in the postoperative period is pain and the associated deterioration in sleep quality. Deterioration in sleep quality can cause pain to be perceived more severely. It is recommended to use non-pharmacological approaches as well as pharmacological interventions in the management of these problems. This study was planned to determine the effect of hot foot bath and lavender essential oil foot bath application on postoperative sleep quality and pain in patients undergoing abdominal surgery.

详细描述

It was planned as a randomized controlled trial. The population of the study consisted of patients who underwent abdominal surgery in the General Surgery Service of a private health group hospital in Istanbul. Patients who met the inclusion criteria constituted the sample.

"Visual Comparison Scale-VAS" and "Richard-Campbell Sleep Scale" were used during data collection.

Visual Comparison Scale-VAS: It is a scale that starts with no pain and ends with unbearable. The VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain.

Richard-Campbell Sleep Scale: This scale consists of 6 items that evaluate the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level of the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. According to the scale, the score in the range of "0-25" indicates very bad sleep, and the score in the range of "76-100" indicates very good sleep.

Foot bath was started as of the 24th hour after the operation. During the 3 days they were hospitalized, they had a foot bath evening before going to sleep (experimental group). Routine service applications were performed in the control group. In order to ensure the comfort of the experimental and control group patients and to minimize their exposure to the external environment, the patient rooms were kept clean, at a suitable temperature (23-25 degrees) and quiet.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and over
  • Electively planned robotic and laparoscopic abdominal (colorectal, hepatobiliary, gastric and esophageal surgery, bariatric surgery, peritoneal membrane cancer) surgical operations
  • Surgeries performed under general anesthesia
  • Patients who have been hospitalized for at least 3 days after surgery
  • Patients without a detected sleep disorder (Patients with Insomnia Severity Index score between 0-7) will be included in the study.

排除标准

  • Patients who constantly take a foot bath
  • Emergency surgeries
  • Those with literacy disabilities
  • Those with physical and mental disabilities
  • Patients with diabetes for more than 10 years
  • Patients with diabetic foot, neuropathy, foot pressure sores or any skin disease on their feet
  • Those with vascular diseases
  • Those who are allergic to lavender
  • Those with neurological diseases (dementia, alzheimer, etc.)
  • Those who regularly use sleep and psychoactive drugs
  • Those who use drugs that affect sleep during hospitalization (sedatives, etc.)
  • Patients who were transferred to the post-operative revision or general intensive care unit will not be included in the study.

结局指标

主要结局

Change between Post-operative Pain Score

时间窗: Post-operative Change between Pain Score; 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour, 68th Hour, 72nd Hour (data collection will be finished here)

The Pain scale - VAS scale consists of a 10 cm long line. At one end of the line, "no pain" signals what may be at the other end of the "unbearable pain." The patient is asked to point to a point that indicates the current level of pain. The difference between pain scores over 3 days will be evaluated in hospital Patient's pain was evaluated with VAS - 14 times after surgery. Immediately after surgery means 0th hour. These times; post-operative 24th hour, 28th hour, 32nd hour, 36th hour, 40th hour, 44th hour, 48th hour, 52nd hour, 56th hour, 58th hour, 62nd Hour, 64th Hour., 68th Hour, 72nd Hour. It will be measured for the last time at 72 hours and data collection will be finished here

次要结局

  • Change between Sleep Scale Score(Post-operative change between sleep scale score; 24th Hour, 48th Hour, 72th Hour (data collection will be finished here))

研究者

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

Acibadem University

Asisst. Prof.

Acibadem University

研究点 (2)

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