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临床试验/NCT04596904
NCT04596904已完成不适用

The Effect of Lavender Smell on Anxiety Due to Endoscopic Procedures

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2017年11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
发起方
入组人数
124
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

Esophagogastroduodenoscopy and colonoscopy are invasive procedures that enable the diagnosis, diagnosis, treatment, biopsy, photo and video recording of the gastrointestinal tract. It has an important place in clinical use for diagnosis and treatment and these procedures are common. When the studies are examined; while the prevalence of gastroesophageal reflux disease was 8.8% -25.9% in Europe, approximately 20% of the population in the world were found to have dyspeptic complaints. In the UK, 41,000 new colorectal cancers were diagnosed in 2014 and 132700 new cases were detected in the United States in 2015. In the European Union countries, the incidence of gastrointestinal cancer reported in 2012 is 684,000 cases.

During endoscopic interventions in our country; in Turkey; people may experience high levels of anxiety considering the negative consequences of discomfort and pain.In such cases, nurses should make attempts to reduce the anxiety of the person by predicting that people may have anxiety. Non-pharmacological methods that may reduce anxiety include; pre-treatment training, aromatherapy, acupuncture, hypnosis. Eliminating or reducing anxiety as much as possible will help increase the comfort of both the patient and the endoscopist in these invasive procedures. In our study, our aim was to evaluate the effect of non-pharmacological methods on the preoperative lavender smell.

详细描述

Type and purpose of the study: This randomized controlled trial was planned to evaluate the effect of volatile lavender oil on the level of instantaneous and sustained anxiety level of the patients undergoing endoscopic procedure.

Time and place of study:

The research is carried out in Eskişehir Osmangazi University Gastroenterology Polyclinic.

Universe and sample: The population of the study was applied to the gastroenterology outpatient clinic for diagnosis and diagnosis. The sample of the research sample will be composed of people who meet the sample selection criteria in the specified universe.Chi-Square Test Power analysis was used to determine the sample number of the study. The statistical power was calculated as 118 people with 82%, alpha 0.05, beta 0,1741 errors and 59 persons in group A and 59 persons in group B. In the calculation of the power analysis, Hu et al. (2010) evaluated the effect of lavender in the management of anxiety related to colonoscopy.

Randomization: Within the scope of the study, written consent was obtained after the individuals were informed by the researchers. Randomization method was randomized to two groups [(lavender oil group (A), control group (B)]. The registration numbers and the group numbers of the individuals will be delivered to the researchers in a closed envelope and the lavender oil / distilled water will be sniffed according to the group of the individual before the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •The volunteers who will undergo esophagogastroduodenoscopy or colonoscopy to the gastroenterology outpatient clinic were included in the study.

排除标准

  • •Having cardiovascular disease, Asthma Known history of allergy To be diagnosed psychiatric disease (anxiety / panic attack / depression) To take anxiolytic medication (such as benzodiazepines, selective serotonin reuptake inhibitors, To use products such as antiperspirant, perfume, spray containing any fragrance to the hair and body before the procedure.

研究组 & 干预措施

Lavender oil group

Experimental

Individuals, for 10 days, 3 drops of cotton drops of lavender oil, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.

干预措施: Lavender oil application group (Other)

Distilled water group

Placebo Comparator

Individuals, for 10 days, 3 drops of cotton drops of distilled water, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.

干预措施: Distilled water application group (Other)

结局指标

主要结局

Change of the State-Trait Anxiety Inventory Scores

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

An individual identification form and the State-Trait Anxiety Inventory were used to collect the data.It is a self-assessment questionnaire consisting of short statements.It includes the feature of describing how the individual feels at a certain moment and under certain conditions and responding by taking into account their feelings about the situation. In reliability analysis, Cronbach alpha internal consistency coefficients; 0.94-0.96 for State Anxiety Inventory; it is between 0.83 and 0.87 for the Trait Anxiety Inventory.The unchanged value for the State Anxiety Inventory is 50 and 35 for the Trait Anxiety Inventory. The last obtained value is the individual's anxiety score.

次要结局

未报告次要终点

研究者

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

Fatmanur Ince Ozgenel

Nurse

Eskisehir Osmangazi University

研究点 (1)

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