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临床试验/NCT05377983
NCT05377983Unknown不适用

The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft: a Randomized Controlled Trial Protocol

Marmara University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Sleep quality

研究概览

简要总结

Cardiovascular diseases are among the important health problems due to their increasing frequency and extensity in developed and developing countries. The most common method of treating cardiovascular diseases is Coronary Artery Bypass Graft (CABG) surgery. Common pain, sleep problems, and anxiety after CABG surgery can cause delay in postoperative recovery both physically and mentally. The study was planned to evaluate the effect of lavender oil inhalation on pain, anxiety level and sleep quality after CABG surgery.

详细描述

The study is a non-drug clinical, randomized controlled study, and will be conducted in the Cardiovascular Surgery Clinic of Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi associated to Istanbul Provincial Directorate of Health between December 2020 and December 2021. Criteria to be included in the study were determined as patients who are aged 18 years and over, underwent planned (elective) CABG surgery, whose lavender oil allergy test is negative, who is conscious with place, person and time orientation, who do not have any disability that would make communication difficult, can be communicated in Turkish, were informed to participate in the study and gave written consent. Criteria to be excluded from the study were determined as patients who are allergic to lavender, cosmetics and perfume, have a history of dermatitis, are diagnosed with sleep disorders and use any pharmacological and herbal medicines for these disorders, have sinusitis, upper respiratory tract infection, liver and kidney dysfunction, asthma and Chronic Obstructive Pulmonary Disease (COPD), whose blood pressure is not regulated, have arrhythmia, use controlled analgesia after surgery and cannot be communicated in Turkish. Criteria to be eliminated from the study were determined as patients, who have positive lavender oil allergy test, develop lavender allergy during application, want to leave the study voluntarily, and do not comply with the working process and conditions.

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)

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

  • The inclusion criteria for the study were determined as follows:
  • 18 years of age or older,
  • undergoing elective CABG surgery,
  • negative lavender oil allergy test,
  • being conscious and oriented to place, person, and time,
  • not having any disability that would make communication difficult,
  • being able to communicate in Turkish, and
  • giving informed written consent to participate in the study.

排除标准

  • The exclusion criteria for the study were determined as follows:
  • diagnosed with a sleep disorder or using any pharmacological and/or herbal medicine for insomnia,
  • being allergic to lavender, cosmetics, or perfume,
  • having a history of dermatitis,
  • sinusitis,
  • upper respiratory tract infection,
  • liver and kidney dysfunction,
  • asthma, and
  • chronic obstructive pulmonary disease,
  • not having regulated blood pressure,
  • having arrhythmia,
  • using patient-controlled analgesia after surgery,
  • not being able to communicate in Turkish.
  • The remaining exclusion criteria were determined as follows:
  • a positive lavender oil allergy test,
  • development of lavender allergy during the study,
  • voluntarily deciding to leave the study, and
  • not complying with the study process and conditions.

结局指标

主要结局

Sleep quality

时间窗: Up to five days

Sleep quality will also be evaluated using RCSQ every morning during.

Pain intensity

时间窗: Up to five days

Pain intensity, will be evaluated by NRS 3 times a day in the intervention and control group upon admission from the intensive care unit to the clinic, before and 30 minutes and four hours after each analgesic administration.In addition to this application, pain intensity will be evaluated with NRS before and five minutes after lavender oil inhalation in intervention group patients.

Anxiety level

时间窗: Up to five days

Anxitey level will be evaluated using the STAI-I at four hours after analgesic administration in the intervention group and at five minutes after lavender oil inhalation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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