- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522554
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
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
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
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)
March 2, 2026
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
June 22, 2027
Study Registration Dates
First Submitted
March 30, 2026
First Submitted That Met QC Criteria
April 7, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
April 13, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Labor Pain and Anxiety
-
Pınar ErdoğanRecruitingLabor Progress | Labor Pain and AnxietyTurkey (Türkiye)
-
University of BasrahNot yet recruitingLabor Pain | Labor Anxiety | Labor Stress | Labor Depression
-
Balikesir UniversityCompletedAnxiety | Labor Pain | Duration of Labor | Labor ComfortTurkey
-
Wan-Lin PanSaint Paul's Hospital, Congregation Of The Sisters Of Saint Paul De ChartresNot yet recruitingEffectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring WomenAnxiety | Childbirth Experience | Relieve Pain
-
University Tunis El ManarNot yet recruiting
-
Marmara UniversityThe Scientific and Technological Research Council of TurkeyRecruiting
-
Nilgun AvciCompletedStress, Psychological | Anxiety | Labor PainTurkey (Türkiye)
-
Özlem ÇağanCompletedAnxiety | Aromatherapy | Pain, LaborTurkey
-
Abant Izzet Baysal UniversityCompleted
-
University Tunis El ManarHypnoVREnrolling by invitation
Clinical Trials on Lavender and Lemongrass Aromatherapy
-
National University Hospital, SingaporeCompletedCataract | Surgery | Preoperative Anxiety | Vitrectomy | AromatherapySingapore
-
Postgraduate Institute of Dental Sciences RohtakCompletedPain | Dental AnxietyIndia
-
Cedars-Sinai Medical CenterRecruitingRhinitis, Vasomotor | Thyroid Nodules | Inferior Turbinate Hypertrophy | Vocal Fold Immobility | Chronic Rhinosinusitis (CRS)United States
-
Brigham and Women's HospitalCompletedStress | Anxiety | Emergency Department | AromatherapyUnited States
-
Acibadem UniversityCompletedBreast Cancer | Anxiety State | Patient Satisfaction | Patient Relations, NurseTurkey
-
San Gallicano Dermatological Institute IRCCSCompletedMelanoma | Preoperative Anxiety | Non-Melanoma Skin Cancer | pT1aItaly
-
Universitas Islam IndonesiaCompletedPain | Anxiety | AromatherapyIndonesia
-
Tokat Gaziosmanpasa UniversityCompleted
-
Near East University, TurkeyCompleted