跳至主要内容
临床试验/NCT05692700
NCT05692700已完成不适用

THE EFFECT OF INHALED LAVENDER AND BERGAMOT OIL ON ANXIETY AND SLEEP QUALITY OF SURGICAL INTENSIVE CARE PATIENTS

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年5月2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
54
试验地点
1
主要终点
Insomnia in intensive care patients who have undergone surgery assessed by State-Trait Anxiety Scale

研究概览

简要总结

This study was carried out as a randomized controlled experimental study to determine the effect of inhaled lavender and bergamot oil on anxiety and sleep quality in patients hospitalized in the intensive care unit who had undergone surgical intervention.

The universe of the research; Patients who were hospitalized in an Intensive Care Unit in Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the criteria for inclusion in the study. Fifty-four patients who agreed to participate in the study and met the inclusion criteria were included. Lavender oil or bergamot oil or distilled water was administered to the patients 2 evenings by inhalation.

详细描述

The universe of the research; Patients who were hospitalized in the Intensive Care Unit of a university hospital in Istanbul between May 2021 and October 2021, and the sample consisted of patients who met the inclusion criteria of the study. Data collection started after obtaining the ethics committee permission, institutional permission, and research permission from the Ministry of Health GETAT Clinical Research Department. A simple computer-assisted randomization method was used to distribute the groups homogeneously. Fifty-four patients who were hospitalized in the reanimation intensive care unit and accepted to participate in the study and met the inclusion criteria were included. The patients were randomly assigned to 3 groups of 18 people, each with distilled water, lavender oil, and bergamot oil. "Patient Information Form", "Patient Follow-up Form", "State-Trait Anxiety Inventory" and "Richard-Campbell Sleep Scale (RCUS)" were used to collect data.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old and under 70 years old.
  • Staying in the intensive care unit for at least 3 nights after surgery.
  • Ability to communicate ("Richmond Agitation Sedation Scale" +1, 0, -1 points).
  • Glasgow coma scale score of 9 or higher.

排除标准

  • Having pain.
  • Having any problems with smelling.
  • The need for mechanical ventilation.
  • Systolic blood pressure below 100 mm Hg.
  • Having lung cancer, asthma and chronic obstructive pulmonary disease.
  • Having allergies to known plants, flowers and related essential oils.
  • Using any medication for anxiety and sleep problems.

结局指标

主要结局

Insomnia in intensive care patients who have undergone surgery assessed by State-Trait Anxiety Scale

时间窗: 1 year

State-Trait Anxiety Scale It is a scale used to evaluate the status, continuity and anxiety of patients. It is widely used in hospitals and clinics. The scale is in the form of two separate scales and consists of a total of forty items. The total score calculated from the two scales varies between 80 and 20. The higher the total anxiety score, the higher the anxiety level, and the lower the anxiety level, the lower the anxiety level.

Insomnia in intensive care patients who have undergone surgery assessed by Richards-Campbell Sleep Scale

时间窗: 1 year

Richards-Campbell Sleep Scale In 1987, Richards K developed the Richard-Campbell Sleep Scale. It is used to evaluate sleep quality in patients and patients in the intensive care unit. The Richards-Campbell Sleep Scale evaluates sleep depth, time to fall asleep and number of awakenings, as well as sleep efficiency and quality with 6 questions. The sixth question was adapted to assess perceived night noise. The first 5 questions are taken into the calculation of the score, the score of the 6th question is not added. It is scored on a visual analog scale ranging from 0 mm to 100 mm, and low scores (0-25 points) represent poor sleep and higher scores (76-100 points) represent good sleep. The mean score of the five items is known as the total score and represents the overall perception of sleep.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

ÇAĞLA TOPRAK

specialist nurse

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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