Lavender and Lemongrass Aromatherapy for Pain and Anxiety in Labor: A Randomized Trial

NCT07522554 | Active Not Recruiting

• 1 other identifier: 91471425.2.3001.0086
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain and Anxiety

Keywords

Pregnant Women; Labor Pain; Anxiety; Labor; Complementary Therapies; Lavender; Lemongrass; Aromatherapy

Outcome Measures

Primary Outcomes (2)

• Labor Pain Intensity

  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).

  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 During Labor

  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

  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.

Secondary Outcomes (2)

• 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.

Other Outcomes (1)

• Adverse Reactions to the Intervention

  From the time of study enrollment until delivery.

Study Arms (2)

Lavender and Lemongrass Aromatherapy

EXPERIMENTAL

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.

Behavioral: Lavender and Lemongrass Aromatherapy

Placebo

PLACEBO COMPARATOR

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.

Behavioral: Placebo (Sweet Almond Oil)

Interventions

Placebo (Sweet Almond Oil) BEHAVIORAL

The placebo intervention will consist of sweet almond oil applied to an absorbent material placed inside a personal necklace device, allowing continuous inhalation throughout labor. The placebo has a characteristic odor but no known therapeutic effect on pain or anxiety. The procedure, timing, and conditions of administration will be identical to those of the intervention group.

Placebo

Lavender and Lemongrass Aromatherapy BEHAVIORAL

Aromatherapy will be administered using a combination of lavender (Lavandula angustifolia) and lemongrass (Cymbopogon citratus) essential oils. The essential oils will be applied to an absorbent material placed inside a personal necklace device, allowing continuous inhalation throughout labor. The intervention will be initiated during the active phase of labor and maintained according to the study protocol. The concentration and volume of essential oils will be standardized for all participants.

Lavender and Lemongrass Aromatherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Individuals who self-identify as women and are in labor are eligible to participate; eligibility is also based on biological capacity for pregnancy and childbirth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Nursing, University of São Paulo (EEUSP)

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• Burns E, Blamey C, Ersser SJ, Barnetson L, Lloyd AJ. The use of aromatherapy in intrapartum midwifery practice: a randomized controlled trial. Complement Ther Clin Pract. 2007;13(4):238-244. Levett KM, Smith CA, Bensoussan A, Dahlen HG. Complementary therapies for labour and birth study: a randomized controlled trial of antenatal integrative medicine for pain management in labour. BMJ Open. 2016;6:e010691. Smith CA, Levett KM, Collins CT, Dahlen HG. Aromatherapy for pain management in labour. Cochrane Database Syst Rev. 2018;3:CD009215. Boaviagem A, Melo Junior E, Lubambo L, et al. The effectiveness of aromatherapy in reducing pain and anxiety during labor: a systematic review and meta-analysis. J Altern Complement Med. 2021;27(3):197-208. Yazdkhasti M, Pirak A. The effect of aromatherapy with lavender on pain and anxiety during labor: a systematic review and meta-analysis. Complement Ther Clin Pract. 2016;25:81-86.

  BACKGROUND

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders

Interventions

almond oil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Model Details: This is a randomized, controlled, parallel-group clinical trial with two arms: aromatherapy with lavender and lemongrass, and placebo. Participants will be randomly allocated in a 1:1 ratio. Participants will be blinded, and outcome assessment and data analysis will be performed by blinded researchers whenever possible.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): June 22, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)