Effect of Lavender (Lavandula Angustifolia) and Lemongrass (Cymbopogon Citratus) Aromatherapy on Pain and Anxiety in Labor: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Labor Pain Intensity
研究概览
简要总结
Introduction: Pain experienced during labor is considered one of the main determinants of women's subjective experience throughout this physiological process. In parallel, anxiety is understood as an emotional response triggered by the unpredictability of childbirth, the perception of pain, and concerns regarding fetal well-being. In this context, aromatherapy, classified as a Complementary and Integrative Health Practice (CIHP), is based on the therapeutic use of essential oils (EOs), aiming to promote individuals' physical and emotional well-being. Despite growing interest in incorporating such practices into obstetric care, there remains a significant gap in robust scientific evidence regarding the effectiveness and safety of aromatherapy during labor. Objectives: To evaluate the effect of aromatherapy using essential oils of lavender (Lavandula angustifolia Mill.) and lemongrass (Cymbopogon citratus [DC.] Stapf) in reducing pain and anxiety in women during active labor. Method: This is a randomized, controlled, triple-blind, longitudinal, and prospective clinical trial to be conducted at a public maternity hospital in São Paulo. The sample will consist of parturients aged between 18 and 40 years, with full-term pregnancies, no comorbidities, and no contraindications for the use of essential oils. Participants will be randomly assigned to two groups: inhalation via an aromatic necklace containing lavender and lemongrass essential oils (Experimental Group - EG), or inhalation of a placebo substance with no therapeutic potential (Control Group - CG). Validated instruments will be used to assess the primary outcomes: the Visual Analog Scale (VAS) for measuring pain intensity and the State-Trait Anxiety Inventory (STAI) for evaluating anxiety levels during the active phase of labor, defined as a cervical dilation greater than five centimeters and at least two effective contractions within ten minutes. Data will be analyzed using statistical methods, with a significant level of 0.05 and a 95% confidence interval. The analysis will include descriptive, exploratory, and inferential procedures, applying both parametric and non-parametric statistical tests as appropriate. Expected results: It is expected that laboring women exposed to aromatherapy with lavender and lemongrass will report lower pain intensity and reduced anxiety levels compared to the control group. It is believed that the use of aromatherapy during labor may promote the physical and emotional well-being of pregnant women, support the physiological progression of labor, and enhance maternal satisfaction with the therapeutic approach, without the occurrence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will adopt a triple-blind design, with masking of participants, researchers, and statisticians:
Participants: Will be blinded to the intervention received, as the necklaces and substances (essential oils and placebo) will be sensorially indistinguishable; Research team: Investigators responsible for data collection will be blinded to group allocation; Data analyst: Statistical analysis will be performed using a coded dataset (e.g., Group A and Group B), and group identification will only be revealed after completion of the analyses.
To reduce detection bias, there will be a distinction between researchers administering the intervention (experimental or control) and those assessing outcomes. This separation of roles helps prevent differential behavior based on knowledge of participants' group allocation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 40 years, regardless of parity; Term pregnancy (gestational age between 37 weeks and 41 weeks and 6 days), with a single, live fetus in cephalic presentation;
- •Active labor, defined as cervical dilation ≥5 cm, confirmed by vaginal examination, and the presence of at least two effective uterine contractions (≥40 seconds) within 10 minutes;
- •Pain score ≥4 assessed by the Visual Analog Scale (VAS), and anxiety level ≥30 assessed by the State-Trait Anxiety Inventory - State (STAI-S) at the pre-intervention moment;
- •No language barriers that would prevent understanding of the Portuguese language.
排除标准
- •Presence of obstetric comorbidities or systemic conditions, such as hypertensive disorders, metabolic disorders, hemorrhagic conditions, pulmonary diseases (e.g., rhinitis, asthma), heart diseases, coagulation disorders, autoimmune diseases, among others;
- •Prior use of pharmacological analgesia before the intervention (e.g., epidural analgesia, nitrous oxide, scopolamine butylbromide);
- •Prior use of anxiolytics or antidepressants, regardless of pharmacological class;
- •Presence of olfactory disorders that may interfere with the administration of essential oils;
- •Known allergies to essential oils or hypersensitivity reactions occurring during the study.
研究组 & 干预措施
Lavender and Lemongrass Aromatherapy
Participants will receive aromatherapy using a combination of lavender (Lavandula angustifolia) and lemongrass (Cymbopogon citratus) essential oils. The intervention will be administered via a personal necklace device, allowing continuous inhalation during labor.
干预措施: Lavender and Lemongrass Aromatherapy (Behavioral)
Placebo
Participants will receive a placebo intervention administered via an identical personal necklace device containing sweet almond oil, which has a characteristic odor but no known therapeutic effect for pain or anxiety. The same procedures as the intervention group will be followed.
干预措施: Placebo (Sweet Almond Oil) (Behavioral)
结局指标
主要结局
Labor Pain Intensity
时间窗: From the active phase of labor (cervical dilation ≥5 cm with at least two effective contractions lasting >40 seconds), assessed at three time points: before the intervention, 20 minutes after the intervention, and 1 hour after the intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates the worst possible pain. Scores will be categorized as mild (1-3), moderate (4-7), and severe (8-10).
Maternal Anxiety During Labor
时间窗: From the active phase of labor (cervical dilation ≥5 cm with at least two effective contractions lasting >40 seconds), assessed at three time points: before the intervention, 20 minutes after the intervention, and 1 hour after the intervention.
Maternal anxiety will be assessed using the State-Trait Anxiety Inventory - State (STAI-S; range 20-80), where higher scores indicate greater anxiety. Scores will be categorized as low (20-39), moderate (40-59), and high (60-80) anxiety
次要结局
- Labor Progression (Cervical Dilation Rate)(From the moment of study inclusion until birth.)
- Maternal Satisfaction(The questionnaire will be administered within 24 hours after delivery.)
研究者
Victor Hugo Alves Mascarenhas
Master of Science
University of Sao Paulo