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临床试验/NCT05276505
NCT05276505已完成不适用

Evaluation of the Efficacy of Two Different Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

Acibadem University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年7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
135
试验地点
1
主要终点
State Anxiety Level

研究概览

简要总结

A breast biopsy is a cause for anxiety for most women when faced with a diagnosis of breast cancer. Physiological and psychological effects of breast biopsy may continue in the pre-biopsy and post-biopsy period. The aim of this study is to compare the effectiveness of two different aromatherapy methods applied in reducing anxiety before breast biopsy.

详细描述

Anxiety level was evaluated according to objective criteria by pretesting and posttesting lavender, lavender-mint and odorless (placebo) aromatherapy tablets applied before the biopsy in patients scheduled for breast biopsy.

The study was conducted with 135 patients, 90 of whom were in the experimental group and 45 in the control group. Patients were randomly assigned to the experimental and control groups according to their sequence numbers.

Before the biopsy, lavender aromatherapy and lavender-mint aromatherapy tablets were administered to the experimental group, and an odorless (placebo) aromatherapy tablet to the control group. Aromatherapy tablets 20 minutes after the procedure. First, a small (approximately 1x 0.5 inch), rectangular, absorbent, self-adhesive tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level. Research data were collected with the "Spielberger State Anxiety Scale" to determine the level of anxiety before and after breast biopsy.

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 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •over 18 years old
  • •Female patients scheduled for breast biopsy (stereotactic biopsy, ultrasound biopsy, magnetic resonance imaging biopsy)
  • •Individuals who can speak, understand and communicate in Turkish will be included in the study.

排除标准

  • •Pregnant and lactating women,
  • •Patients who are allergic to plants (lavender/lavender-mint),
  • •Patients with a diagnosis of psychiatric illness, migraine, chronic headache or sense of smell
  • •Patients who have difficulty breathing through their nose
  • •People who can't smell, who are sensitive to smells or smells
  • •Patients with a history of asthma, epilepsy or seizures as a precaution.
  • •Patients with active wheezing
  • •Patients with cognitive, verbal or hearing problems that may affect communication

研究组 & 干预措施

Control Group - Standardized care

No Intervention

Standardized nursing care applications

Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure

Experimental Group- Lavender Aromatherapy Tablet

Experimental

Before 20 minutes from breast biopsy. Lavender aromatherapy tablets. A small (approximately 1x 0.5 inch), rectangular, absorbent tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level in the waiting room.

Patients were asked to inhale the aromatherapy tablet for 20 minutes before the procedure.

Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure

干预措施: Lavender Aromatherapy Tablet (Other)

Experimental Group- Lavender-Mint Aromatherapy Tablet

Experimental

Before 20 minutes from breast biopsy. Lavender-Mint aromatherapy tablets. A small (approximately 1x 0.5 inch), rectangular, absorbent tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level in the waiting room.

Patients were asked to inhale the aromatherapy tablet for 20 minutes before the procedure.

Evaluation with STAI scale (anxiety levels) breast biopsy Evaluation with the STAI scale (anxiety levels) after the breast biopsy procedure

干预措施: Lavender Aromatherapy Tablet (Other)

结局指标

主要结局

State Anxiety Level

时间窗: Evaluation of the differences between anxiety scales score - The scale is filled in 2 times - before breast biopsy (1), and after immediately breast biopsy (2)

State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level

次要结局

未报告次要终点

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 (1)

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