A patient in eastern Turkey
Batman, Turkey (Türkiye)
NCT Number: NCT06664671
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Batman, Turkey (Türkiye)
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."
Data Collection Procedure Data collection will occur in a Teaching and Research Hospital's pulmonary ward from November 2024 to February 2025. Patients will be randomized into intervention, placebo, or control groups.
Data Analysis Data analysis will be conducted using SPSS. Shapiro-Wilk Test will assess normality. Significance is set at p < 0.05. If variables are normally distributed (p > 0.05), parametric tests will be applied. Chi-square analysis will be used for categorical data. Paired t-tests will assess within-group differences, while repeated-measures ANOVA will test differences across groups, with variance homogeneity and multivariate normality checks.
Ethics Ethical approval for the study was obtained from the Inonu University Clinical Research Ethics Committee, and institutional permission was granted by Batman Training and Research Hospital. The protocol follows the Helsinki Declaration, and all participants will be informed about data confidentiality, their right to withdraw, and that no charges or costs will be incurred.
Research Hypotheses
The following hypotheses will be tested regarding the effects of thyme oil:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will inhale thyme oil via inhaler sticks with instructions on proper usage, supervised by the researcher. Each patient will complete the Patient Introduction Form, Asthma Control Test, and pre-test sections of the Asthma Symptom and Respiratory Parameters Form. Measurements of FEV1 and FEV1/FVC will be recorded. On the fourth day of hospitalization, post-test data will be collected.
Patients will receive an empty inhaler stick with usage instructions, completing the same pre- and post-test procedures as the intervention group.
Patients will complete pre- and post-test forms without any intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 4 days
Thyme oil improves respiratory parameters in patients with asthma.
Inonu University
Other
The Effect of Thyme Oil on Asthma Control and Respiratory Parameters in Asthmatic Patients
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