AnxietyNCT07480668
Aromatherapy for Mental Health Promotion in IVF Patients
A study testing Lavender essential oil Inhalation and Synthetic lavender aroma inhalation in people with Anxiety and Stress, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The experience of infertility can cause significant emotional instability, especially for patients awaiting In Vitro Fertilization (IVF) treatment, generating anxiety, stress, and depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Stress, Depression Disorder
- What is being tested?
- Lavender essential oil Inhalation and Synthetic lavender aroma inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender, age over 18 years.
- Diagnosis of infertility with indication for In Vitro Fertilization (IVF).
- Patients on the waiting list at HC-UFMG.
- Agreement not to practice other mind-body or herbal complementary therapies during the study.
- DASS-21 screening score compatible with at least mild anxiety, stress, and/or depression.
- No aversion to inhaling essential oil or synthetic lavender essence.
Who cannot join
- Severe neurological, psychiatric, or clinical disorders (e.g., schizophrenia, severe depression) that prevent participation.
- Use of medications that could confound the primary outcome (e.g., sleep medications, anxiolytics, antidepressants, neuroleptics) in the 30 days prior to or during the study.
- Known allergy to lavender products.
- Pregnancy during the study period.
- Use of essential oils in the last 90 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bárbara P Aquino, MSc contact
Brazil1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology - Federal University of Minas Gerais - Brazil
Belo Horizonte, Minas Gerais, 30130-100
Rubens L C Tavares, MD, PhD, rubens.ufmg@gmail.com
Bárbara P Aquino, MSc, babiaquino.aromaterapia@gmail.com
About this study
Official title: Aromatherapy for Mental Health Promotion in In Vitro Fertilization Patients: a Randomized Clinical Trial
The experience of infertility can cause significant emotional instability, especially for patients awaiting In Vitro Fertilization (IVF) treatment, generating anxiety, stress, and depressive symptoms. This study is a randomized clinical trial assessing the effectiveness of aromatherapy in improving mental health and quality of life in women undergoing infertility treatment. 120 participants will be randomized into three groups (Intervention, Placebo, and Control). The intervention involves the inhalation of true lavender essential oil (Lavandula angustifolia) for four weeks.
Read the detailed description
Infertility is a condition that affects approximately one in six people globally and is associated with high levels of psychological distress. Complementary therapies, such as aromatherapy, emerge as potential strategies to promote emotional well-being. This prospective, randomized, controlled clinical trial will be conducted at the Hospital das Clínicas da UFMG. Participants will be women on the waiting list for IVF. They will be randomized into three groups:
- Intervention Group: Inhalation of Lavandula angustifolia essential oil.
- Placebo Group: Inhalation of synthetic lavender essence.
- Control Group: Routine care only. The intervention consists of inhaling 5 drops of the substance using a personal nasal inhaler stick, twice daily (morning and night) for 15 minutes, over a period of 4 weeks. Efficacy will be measured using validated scales for anxiety, depression, stress (DASS-21), quality of life (FertiQoL), insomnia (ISI), Human Flourishing Scale (HFS), Duke Religiosity Index (DUREL), Visual Analogue Scale (VAS) for pain, General Health Questionnaire (GHQ-12) and a Qualitative questionnaire at baseline, immediately post-intervention (Week 4), and at follow-up (Week 8).
- Conditions
- Anxiety, Stress, Depression Disorder, Quality of Life, Aromatherapy, IVF
- Being tested
- Lavender essential oil Inhalation, Synthetic lavender aroma inhalation
- Keywords
- Infertility, Female, Aromatherapy, Lavender Oil, Complementary Therapy, Spirituality, IVF, Anxiety, Stress, Depression, In Vitro Fertilization
- Medical subject headings
- Anxiety Disorders, Infertility, Infertility, Female, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender essential oil InhalationOther
The inhalation of lavender essential oil will be performed twice a day, preferably upon waking and before nighttime sleep. Participants will be instructed to settle into a quiet environment, lying down or sitting, to consciously perform the inhalation. The procedure consists of opening the inhaler, positioning it approximately 1cm from the nostrils, and beginning the inhalation through habitual breaths.The protocol stipulates that each inhalation session lasts 15 minutes, which can be timed on the participant's own cell phone. After the inhalation is finished, the inhaler should be kept closed. To facilitate monitoring and ensure adherence to the protocol, participants will receive a weekly schedule to record completed sessions and will be encouraged to keep an aromatherapy diary to record their perceptions and feelings throughout the study, providing qualitative data that will contribute to analyzing the effect of the practice on the well-being of women undergoing fertility treatment.
Synthetic lavender aroma inhalationOther
The inhalation of synthetic lavender essence will be performed twice a day, preferably upon waking and before bedtime. Participants will be instructed to find a quiet environment, lying down or sitting, to consciously perform the inhalation. The procedure consists of opening the inhaler, positioning it approximately 1 cm from the nostrils, and beginning the inhalation through habitual breaths. The protocol stipulates that each inhalation session should last 15 minutes, and the time can be timed on the participant's cell phone. After the inhalation is finished, the inhaler should be kept closed. To facilitate monitoring and ensure adherence to the protocol, participants will receive a weekly schedule to mark completed sessions and will be encouraged to keep an aromatherapy diary to record their perceptions and feelings throughout the study, providing qualitative data that will contribute to the analysis of the practice's effect on the well-being of women undergoing fertility treatment.
| Study group | Role | What they receive |
|---|---|---|
| Lavender essential oil group | Experimental | This intervention group will inhale 5 drops of true lavender essential oil (Lavandula angustifolia), administered via personal inhalers (olfactory sticks). The use of personal inhalers is a safe and widely used low-cost intervention that can be applied practically and accessibly, ensuring greater adherence to the protocol by the participants. The inhalation will be performed daily, upon waking in the morning and at night before sleeping, for four weeks. Receives: Other: Lavender essential oil Inhalation |
| Synthetic lavender aroma group | Placebo comparator | The placebo group will inhale 5 drops of a synthetic lavender aroma, also administered via personal inhalers. Inhalation will be performed daily, upon waking in the morning and at night before sleeping, for four weeks. Receives: Other: Synthetic lavender aroma inhalation |
| Control Group | No intervention | The control group will receive routine care throughout the 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores
he DASS-21 is a set of three self-report scales containing 21 questions to measure emotional states of depression, anxiety, and stress. Each of the three subscales contains 7 items. Scores for each subscale range from 0 to 42 (calculated by summing the scores for the relevant items, which are scored from 0 to 3, and multiplying by 2). Higher scores indicate more severe symptoms of distress.
Measured: Baseline (Time 0), Week 4 (Time 1, end of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)
Secondary outcomes (7)
Change from Baseline in Fertility Quality of Life (FertiQoL) Scores
Assessed using the Fertility Quality of Life (FertiQoL) questionnaire. It evaluates the quality of life in people experiencing fertility problems. Items are scored on a 5-point Likert scale, and raw scores are transformed to a continuous scale ranging from 0 to 100. Higher scores indicate a better fertility-related quality of life.
Measured: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Insomnia Severity Index (ISI) Scores
Assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. Each item is rated on a 5-point Likert scale (0-4). The total score ranges from 0 to 28. Higher scores indicate more severe insomnia.
Measured: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Flourishing Scale (EFH) Scores
Assessed using the Harvard Human Flourishing Program measure. The instrument consists of 12 items scored on a scale of 0 to 10. The total score (Secure Flourish Index) ranges from 0 to 120. Higher scores indicate a higher level of psychosocial prosperity and flourishing.
Measured: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Duke University Religion Index (DUREL) Scores
Measures religious involvement. It contains three subscales: organizational (1-6), non-organizational (1-6), and intrinsic religiosity (3-15). Higher scores indicate higher religiosity.
Measured: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Visual Analog Scale (VAS) for Pain
A continuous scale for pain intensity ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate higher pain intensity.
Measured: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in General Health Questionnaire (GHQ-12) Scores
The General Health Questionnaire (GHQ-12) evaluates psychological distress and current mental health. Scores range from 0 to 36. Higher scores indicate worse psychological well-being and higher levels of distress.
Measured: Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)
Change from Baseline in Qualitative questionnaire
Qualitative questionnaire will analyze, through a qualitative approach, the effects of essential oil inhalation on the subjective well-being of infertile women.
Measured: Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Lene Carvalho Tavares, Federal University of Minas Gerais
- Investigators
- Bárbara P Aquino, MSc, Study chair, Federal University of Minas GeraisJhenifer K Rodrigues, PhD, Principal investigator, POTENTIA - Technical, therapeutic, and human development consulting and advisory servicesRubens L C Tavares, MD, PhD, Principal investigator, Federal University of Minas GeraisUbiratan Brum de Castro, PhD, MD, Study chair, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480668
- Sponsor's protocol ID
- CAEE 94400925.0.0000.0444
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Mental Health Promotion in In Vitro Fertilization Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07480668
- Acronym / sponsor ID
- CAEE 94400925.0.0000.0444
- Conditions
- Anxiety, Stress, Depression Disorder, Quality of Life, Aromatherapy, IVF
- Keywords
- Infertility, Female, Aromatherapy, Lavender Oil, Complementary Therapy, Spirituality, IVF, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Mar 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.
The experience of infertility can cause significant emotional instability, especially for patients awaiting In Vitro Fertilization (IVF) treatment, generating anxiety, stress, and depressive symptoms. This study is a randomized clinical trial assessing the effectiveness of aromatherapy in improving mental health and quality of life in women undergoing infertility treatment. 120 participants will be randomized into three groups (Intervention, Placebo, and Control). The intervention involves the inhalation of true lavender essential oil (Lavandula angustifolia) for four weeks.
Detailed description
Infertility is a condition that affects approximately one in six people globally and is associated with high levels of psychological distress. Complementary therapies, such as aromatherapy, emerge as potential strategies to promote emotional well-being. This prospective, randomized, controlled clinical trial will be conducted at the Hospital das Clínicas da UFMG. Participants will be women on the waiting list for IVF. They will be randomized into three groups:
- Intervention Group: Inhalation of Lavandula angustifolia essential oil.
- Placebo Group: Inhalation of synthetic lavender essence.
- Control Group: Routine care only. The intervention consists of inhaling 5 drops of the substance using a personal nasal inhaler stick, twice daily (morning and night) for 15 minutes, over a period of 4 weeks. Efficacy will be measured using validated scales for anxiety, depression, stress (DASS-21), quality of life (FertiQoL), insomnia (ISI), Human Flourishing Scale (HFS), Duke Religiosity Index (DUREL), Visual Analogue Scale (VAS) for pain, General Health Questionnaire (GHQ-12) and a Qualitative questionnaire at baseline, immediately post-intervention (Week 4), and at follow-up (Week 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lavender essential oil group | Experimental | Other: Lavender essential oil InhalationThis intervention group will inhale 5 drops of true lavender essential oil (Lavandula angustifolia), administered via personal inhalers (olfactory sticks). The use of personal inhalers is a safe and widely used low-cost intervention that can be applied practically and accessibly, ensuring greater adherence to the protocol by the participants. The inhalation will be performed daily, upon waking in the morning and at night before sleeping, for four weeks. |
| Synthetic lavender aroma group | Placebo comparator | Other: Synthetic lavender aroma inhalationThe placebo group will inhale 5 drops of a synthetic lavender aroma, also administered via personal inhalers. Inhalation will be performed daily, upon waking in the morning and at night before sleeping, for four weeks. |
| Control Group | No intervention | –The control group will receive routine care throughout the 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female gender, age over 18 years.
- Diagnosis of infertility with indication for In Vitro Fertilization (IVF).
- Patients on the waiting list at HC-UFMG.
- Agreement not to practice other mind-body or herbal complementary therapies during the study.
- DASS-21 screening score compatible with at least mild anxiety, stress, and/or depression.
Key exclusion criteria (5 listed)
- Severe neurological, psychiatric, or clinical disorders (e.g., schizophrenia, severe depression) that prevent participation.
- Use of medications that could confound the primary outcome (e.g., sleep medications, anxiolytics, antidepressants, neuroleptics) in the 30 days prior to or during the study.
- Known allergy to lavender products.
- Pregnancy during the study period.
- Use of essential oils in the last 90 days.
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 essential oil InhalationThe inhalation of lavender essential oil will be performed twice a day, preferably upon waking and before nighttime sleep. Participants will be instructed to settle into a quiet environment, lying down or sitting, to consciously perform the inhalation. The procedure consists of opening the inhaler, positioning it approximately 1cm from the nostrils, and beginning the inhalation through habitual breaths.The protocol stipulates that each inhalation session lasts 15 minutes, which can be timed on the participant's own cell phone. After the inhalation is finished, the inhaler should be kept closed. To facilitate monitoring and ensure adherence to the protocol, participants will receive a weekly schedule to record completed sessions and will be encouraged to keep an aromatherapy diary to record their perceptions and feelings throughout the study, providing qualitative data that will contribute to analyzing the effect of the practice on the well-being of women undergoing fertility treatment. | Other | Lavender essential oil group |
| Synthetic lavender aroma inhalationThe inhalation of synthetic lavender essence will be performed twice a day, preferably upon waking and before bedtime. Participants will be instructed to find a quiet environment, lying down or sitting, to consciously perform the inhalation. The procedure consists of opening the inhaler, positioning it approximately 1 cm from the nostrils, and beginning the inhalation through habitual breaths. The protocol stipulates that each inhalation session should last 15 minutes, and the time can be timed on the participant's cell phone. After the inhalation is finished, the inhaler should be kept closed. To facilitate monitoring and ensure adherence to the protocol, participants will receive a weekly schedule to mark completed sessions and will be encouraged to keep an aromatherapy diary to record their perceptions and feelings throughout the study, providing qualitative data that will contribute to the analysis of the practice's effect on the well-being of women undergoing fertility treatment. | Other | Synthetic lavender aroma group |
Primary outcome
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores
Time frame: Baseline (Time 0), Week 4 (Time 1, end of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)
he DASS-21 is a set of three self-report scales containing 21 questions to measure emotional states of depression, anxiety, and stress. Each of the three subscales contains 7 items. Scores for each subscale range from 0 to 42 (calculated by summing the scores for the relevant items, which are scored from 0 to 3, and multiplying by 2). Higher scores indicate more severe symptoms of distress.
7 secondary outcomes
Change from Baseline in Fertility Quality of Life (FertiQoL) Scores
Time frame: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Insomnia Severity Index (ISI) Scores
Time frame: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Flourishing Scale (EFH) Scores
Time frame: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Duke University Religion Index (DUREL) Scores
Time frame: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in Visual Analog Scale (VAS) for Pain
Time frame: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
Change from Baseline in General Health Questionnaire (GHQ-12) Scores
Time frame: Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)
Change from Baseline in Qualitative questionnaire
Time frame: Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
Bárbara P Aquino, MSc contact
Bárbara P Aquino, MSc study chair
Federal University of Minas Gerais
Jhenifer K Rodrigues, PhD principal investigator
POTENTIA - Technical, therapeutic, and human development consulting and advisory services
Rubens L C Tavares, MD, PhD principal investigator
Federal University of Minas Gerais
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 essential oil Inhalation and Synthetic lavender aroma inhalation in people with Anxiety and Stress, run by Federal University of Minas Gerais 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 6 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: looking for participants now, as of the sponsor's last update on 29 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?
Contact Rubens L C Tavares, MD, PhD (+55 31 3409-9764, rubens.ufmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores (time frame: Baseline (Time 0), Week 4 (Time 1, end of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.