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

April 7, 2026 updated by: Victor Hugo Alves Mascarenhas, University of Sao Paulo

Effect of Lavender (Lavandula Angustifolia) and Lemongrass (Cymbopogon Citratus) Aromatherapy on Pain and Anxiety in Labor: A Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-000
        • School of Nursing, University of São Paulo (EEUSP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Lavender and Lemongrass Aromatherapy
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.
Placebo Comparator: 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.
Behavioral: Placebo (Sweet Almond Oil)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Labor Pain Intensity
Time Frame: 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).
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
Time Frame: 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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Labor Progression (Cervical Dilation Rate)
Time Frame: From the moment of study inclusion until birth.
Labor progression will be assessed as cervical dilation rate (cm/hour) during the active phase of labor, based on serial cervical examinations.
From the moment of study inclusion until birth.
Maternal Satisfaction
Time Frame: The questionnaire will be administered within 24 hours after delivery.
Maternal satisfaction with the intervention will be assessed using a structured questionnaire based on a 5-point Likert scale (1-5), where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater satisfaction.
The questionnaire will be administered within 24 hours after delivery.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Reactions to the Intervention
Time Frame: From the time of study enrollment until delivery.
Adverse reactions related to the intervention will be monitored throughout the study period and recorded using a structured form, including symptoms such as nausea, headache, dizziness, allergic reactions, or any other reported discomfort.
From the time of study enrollment until delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91471425.2.3001.0086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and confidentiality concerns, as well as institutional and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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