Labor Pain and AnxietyAROMANCT07522554
Lavender and Lemongrass Aromatherapy for Pain and Anxiety in Labor: A Randomized Trial
A study testing Lavender and Lemongrass Aromatherapy in people with Labor Pain and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain and Anxiety
- What is being tested?
- Lavender and Lemongrass Aromatherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2026to 22 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Nursing, University of São Paulo (EEUSP)
São Paulo, São Paulo, 05403-000
About this study
Official title: 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.
- Conditions
- Labor Pain and Anxiety
- Being tested
- Lavender and Lemongrass Aromatherapy, Placebo (Sweet Almond Oil)
- Keywords
- Pregnant Women, Labor Pain, Anxiety, Labor, Complementary Therapies, Lavender, Lemongrass, Aromatherapy
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender and Lemongrass AromatherapyBehavioural
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 (Sweet Almond Oil)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Placebo (Sweet Almond Oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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)
Labor progression will be assessed as cervical dilation rate (cm/hour) during the active phase of labor, based on serial cervical examinations.
Measured: From the moment of study inclusion until birth.
Maternal Satisfaction
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.
Measured: The questionnaire will be administered within 24 hours after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Mar 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor Pain and AnxietyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Alves Mascarenhas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522554
- Sponsor's protocol ID
- 91471425.2.3001.0086
- Acronym
- AROMA
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality concerns, as well as institutional and ethical restrictions.
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 at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lavender (Lavandula Angustifolia) and Lemongrass (Cymbopogon Citratus) Aromatherapy on Pain and Anxiety in Labor: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07522554
- Acronym / sponsor ID
- AROMA / 91471425.2.3001.0086
- Conditions
- Labor Pain and Anxiety
- Keywords
- Pregnant Women, Labor Pain, Anxiety, Labor, Complementary Therapies, Lavender, Lemongrass, Aromatherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lavender and Lemongrass Aromatherapy | Experimental | Behavioral: Lavender and Lemongrass AromatherapyParticipants 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. |
| Placebo | Placebo comparator | Behavioral: Placebo (Sweet Almond Oil)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender and Lemongrass AromatherapyAromatherapy 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. | Behavioural | Lavender and Lemongrass Aromatherapy |
| 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. | Behavioural | Placebo |
Primary outcome
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).
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
2 secondary outcomes
Labor Progression (Cervical Dilation Rate)
Time frame: From the moment of study inclusion until birth.
Maternal Satisfaction
Time frame: The questionnaire will be administered within 24 hours after delivery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- BackgroundBurns 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns, as well as institutional and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender and Lemongrass Aromatherapy in people with Labor Pain and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.