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临床试验/NCT05540418
NCT05540418已完成不适用

The Effect of Lavender Oil Inhalation on Anxiety and Comfort in Patients Undergoing Colonoscopy: A Randomized Controlled, Single-center Study.

Kocaeli University1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
145
试验地点
1
主要终点
Change of the State-Trait Anxiety Inventory scores

研究概览

简要总结

Aim: In this study, it was aimed to determine the effect of lavender oil inhalation on the anxiety and comfort levels of patients who will undergo colonoscopy.

Material and Method: In this randomized controlled, prospective study, 73 experimental and 72 control group patients who will experience colonoscopy in a training and research hospital in western Turkey were included. While lavender inhalation was applied to the patients in the experimental group, routine care was applied to the patients in the control group. The short-form state-trait anxiety scale and general comfort scale were used to collect data before and after the procedure. p<0.05 level was considered statistically significant.

详细描述

Colonoscopy is a painful and uncomfortable procedure, and patients experience anxiety and restlessness / tension before colonoscopy. It is stated that aromatherapy, which is a non-invasive method and easy to apply, can be used to reduce these negative effects.

It is known that the fastest and easiest way of entry of essential oils into the body is inhalation. In addition, it is stated that it is safe to carry out these applications by inhalation; For this reason, studies are mostly carried out by inhalation of essential oils. In studies conducted in different fields, it is seen that lavender has positive effects on variables such as anxiety, pain, insomnia, comfort and vital signs. Looking at the literature; more music therapy and education are applied to patients who will experience anxiety and loss of comfort due to colonoscopy; As for aromatherapy interventions; In a study conducted in 2017 with Sunflower and Neroli (Orange Flower) oil, olive flower oil (Osmanthus fragrans) and grapefruit oil were used.

In this study, it was aimed to determine the effect of lavender essential oil, which has been found to have positive effects on many variables in various studies, on the anxiety and comfort levels that may be experienced in patients who will experience colonoscopy.

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 (Participant)

入排标准

年龄范围
44 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years old, 65 years old and under,
  • having colonoscopy,
  • not having the risk of heart failure and cardiogenic shock (class III and IV),
  • not having a history of asthma, eczema, and allergies to flowers and plants,
  • not allergic to lavender,
  • not having communicative/severe hearing or speech impairment,
  • not using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives
  • having stable vital signs
  • individuals who volunteered to participate in research

排除标准

  • individuals who do not meet the inclusion criteria

结局指标

主要结局

Change of the State-Trait Anxiety Inventory scores

时间窗: Before the colonoscopic procedure - on colonoscopic procedure day

State anxiety inventory determines how an individual feels at a certain moment and under certain conditions. The trait anxiety inventory, on the other hand, is defined as the anxiety that an individual feels in his normal life. Each item in the inventory is evaluated between one and four points. High total scores in the inventories indicate a high state anxiety level of the individual. In the inventory, scores above 42 are considered as "high anxiety level". The internal consistency (Cronbach's Alpha) coefficients of this inventory range from 0.83 to 0.92 for the state anxiety inventory. The State-Trait Anxiety inventory was evaluated 20 minutes before and 20 minutes after colonoscopy in the intervention and control groups. Anxiety level was evaluated with the State-Trait Anxiety inventory before and 20 minutes after lavender oil inhalation in patients in the intervention group.

Change of the Overal Comfort Scale

时间窗: Before the colonoscopic procedure - on colonoscopic procedure day

General Comfort Scale: The scale consists of 28 questions and shows the current comfort status of the patient. The score of the scale varies between 28-168. The Cronbach alpha of the 6-point Likert-type scale is 0.82. The general comfort scale was evaluated 20 minutes before and 20 minutes after colonoscopy in the intervention and control groups. Overall comfort level was assessed before and 20 minutes after lavender oil inhalation in patients in the intervention group. A high score on the scale indicates that the general comfort level of the patients is high.

次要结局

未报告次要终点

研究者

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

SELDA MERT

Assist. Prof. Dr.

Kocaeli University

研究点 (1)

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