The Effect of Thyme Oil on Asthma Control and Respiratory Parameters in Asthmatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Respiratory parameters
研究概览
简要总结
This study is a pre-test post-test randomized controlled trial aimed at examining the effects of thyme oil inhalation on asthma control and respiratory parameters in patients with asthma. It will be conducted with 150 patients (intervention group = 50, placebo group = 50, control group = 50) in the pulmonary ward of a Training and Research Hospital in eastern Turkey. Patients will use either thyme oil-infused or placebo inhaler sticks, inhaling for eight breaths, three times a day for four days. The placebo group will receive an empty inhaler stick, while no intervention will be applied to the control group. Data will be collected from November 2024 to February 2025. The effects of thyme oil will be measured using the Asthma Control Test, Asthma Symptom and Respiratory Parameters Form, FEV1 (Forced Expiratory Volume in 1 second), and FEV1/FVC (Forced Expiratory Volume in 1 second to Forced Vital Capacity ratio) (Modified Tiffeneau-Pinelli index) values.
Hypothesis: It is hypothesized that thyme oil inhalation will significantly improve respiratory function parameters and asthma control levels in patients with asthma.
详细描述
Aim of the Study This study aims to determine the effects of thyme oil on asthma control and respiratory parameters in patients with asthma.
Type of Study This study is a pre-test post-test randomized controlled experimental design.
Population The population comprises inpatients (N = 210) in the pulmonary ward of a Training and Research Hospital located in eastern Turkey. Based on a 95% confidence interval, 5% margin of error, and 95% power analysis, a minimum of 137 patients is required. To minimize attrition, the study aims to include 150 patients (intervention group = 50, placebo group = 50, control group = 50). Data will be collected between November 2024 and February 2025.
Intervention In this study, thyme oil aromatherapy will be applied via inhalation. The product used, with NV-2016 code, contains Nature&Nurture thyme essential oil (10 µL) macra (Barcode No: 8697742121135, Registration No: 381751) and includes components such as 1,3 y-Terpinene, 2.7% p-Cymene, 5.6% linalool, 1.2% terpinen-4-ol, 1.2% borneol, 1.2% β-Bisabolene, 3.2% tymol, and 75.7% carvacrol. The thyme oil will be applied via an inhaler stick with patients instructed to inhale eight breaths, three times daily for four days.
Data Collection Tools Data will be collected using the "Patient Introduction Form," "Asthma Control Test," and "Asthma Symptom and Respiratory Parameters Form."
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •- Patients admitted to the pulmonology ward with a diagnosis of asthma and expected to stay for at least 4 days,
- •Patients admitted on their first day in the pulmonology ward,
- •Age 18 or older,
- •Alert and conscious,
- •Open to communication and cooperation,
- •Willing to participate in the study.
排除标准
- •- Patients under 18 years of age,
- •Patients with pregnancy,
- •Patients with dementia and/or other organic mental disorders,
- •Patients with any psychiatric diagnosis, and
- •Patients who do not wish to participate in the study will be excluded.
结局指标
主要结局
Respiratory parameters
时间窗: From enrollment to the end of treatment at 4 days
Thyme oil improves respiratory parameters in patients with asthma. Its influence on respiratory parameters is assessed using indicators such as FEV1/FVC and FEV1. These respiratory parameters are recorded in the asthma symptom form.
Asthma symptoms
时间窗: From enrollment to the end of treatment at 4 days
Thyme oil effectively alleviates or reduces the severity of asthma symptoms in patients with asthma. Its influence on asthma symptoms is assessed through indicators such as shortness of breath, cough, nocturnal wheezing, chest wheezing, and secretions. The presence of these symptoms and their severity levels are determined using a 10 cm horizontal line scale, with one end labeled "None" and the other end labeled "Severe." This scale serves as a measurement criterion for the outcomes obtained from the study.
Asthma control
时间窗: From enrollment to the end of treatment at 4 days
Thyme oil enhances asthma control in patients with asthma, as measured by symptoms such as wheezing, coughing, shortness of breath, chest tightness or pain, frequency of nebulizer medication use, and interference with work. The maximum score for this assessment is 25, while the minimum is 5. The Asthma Control Test (ACT) scoring is categorized as follows: a score of 25 indicates "complete control," scores between 20-24 indicate "good control," and scores below 19 are classified as "uncontrolled." A higher score reflects better asthma control, whereas scores of 19 or below indicate that the condition is not well-managed, necessitating adjustments in treatment to achieve better control.
次要结局
未报告次要终点
研究者
Zeliha CENGİZ
Associate Professor
Inonu University