The Effect of Lavender Oil Applied Via Inhalation On Headache And Anxiety Level in Individuals Undergoing Hemodialysis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Headache Severity measured by Visual Analog Scale (VAS).
研究概览
简要总结
This randomized controlled study aims to determine the effect of pure lavender oil inhalation on headache severity and anxiety levels in hemodialysis (HD) patients. The research, conducted in three dialysis centers, included a total of 62 patients who were randomly assigned to either an intervention group (n=30) receiving lavender oil inhalation or a control group (n=32) receiving standard care. Data were collected using the Visual Analogue Scale (VAS) for headache severity and the State-Trait Anxiety Inventory (STAI) for anxiety levels.
详细描述
Background: Pain, particularly headaches, is a common symptom in hemodialysis (HD) patients that can significantly impact their quality of life. This study investigates the potential therapeutic effect of an integrative medicine approach-lavender oil inhalation-as a non-pharmacological intervention.
Study Design: This is a multi-center, prospective, randomized, open-label, parallel-assignment controlled study. The study population consists of 62 adult hemodialysis patients from three dialysis centers in a city center in Turkey. Participants were enrolled based on specific inclusion criteria, including experiencing headaches during HD sessions.
Interventions: Patients were randomly assigned to one of two groups. The intervention group (n=30) received pure lavender oil inhalation for 5 minutes, three times a week, at the 2nd hour of their HD session, for a duration of one month. The control group (n=32) continued to receive only their standard hemodialysis care without any additional intervention.
Data Collection and Outcome Measures: Data were collected using a patient introduction form to gather demographic information. For a period of four weeks, headache severity was measured using the Visual Analogue Scale (VAS) immediately before, two hours after the start, and at the end of each dialysis session. Anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI), with the STAI-S applied at the 2nd and 4th hours of dialysis and the STAI-T at the beginning and end of the four-week study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Those who are 18 years of age and over,
- •Able to understand and communicate in Turkish,
- •Receiving hemodialysis treatment three times a week for at least 3 months,
- •Not pregnant and not planning a pregnancy,
- •Having a pain intensity of 3 or more on the Visual Analog Scale, measured twice,
- •Headache that develops during dialysis,
- •Headache worsening throughout the dialysis session,
- •Headache resolves spontaneously within 72 hours after dialysis ends,
- •No visual or hearing impairment,
- •Individuals who could take painkillers when they had pain were included in the study
排除标准
- •Those who are allergic to or uncomfortable with the smell of lavender oil,
- •Having any obstacle to smell,
- •Having a history of asthma,
- •Individuals who used other complementary integrative medicine methods during the treatment process were excluded from the study.
结局指标
主要结局
Headache Severity measured by Visual Analog Scale (VAS).
时间窗: Measured 3 times during each hemodialysis session (immediately before, 2 hours after start, and at the end of dialysis) over a period of 4 weeks (total of 12 sessions).
Headache severity is measured using a 10-unit Visual Analog Scale (VAS) where "0" represents no pain and "10" represents the most severe pain possible. A lower score indicates a reduction in headache intensity
次要结局
- State Anxiety Levels measured by State Anxiety Inventory (STAI-S).(Measured at the 2nd and 4th hours of dialysis sessions throughout the 4-week study period.)
- Trait Anxiety Level (STAI-T)(At the beginning of the study (baseline) and at the end of the 4th week.)
研究者
Goknur Demir Hacimusalar
Phd
TC Erciyes University