Aromatherapy for Mental Health Promotion in IVF Patients

April 24, 2026 updated by: Rubens Lene Carvalho Tavares, Federal University of Minas Gerais

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. Intervention Group: Inhalation of Lavandula angustifolia essential oil.
  2. Placebo Group: Inhalation of synthetic lavender essence.
  3. 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 Type

Interventional

Enrollment (Estimated)

120

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 Contact

Study Contact Backup

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender essential oil group
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.
Other: Lavender essential oil Inhalation
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.
Placebo Comparator: Synthetic lavender aroma group
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.
Other: Synthetic lavender aroma inhalation
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.
No Intervention: Control Group
The control group will receive routine care throughout the 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Time 0), Week 4 (Time 1, end of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measures religious involvement. It contains three subscales: organizational (1-6), non-organizational (1-6), and intrinsic religiosity (3-15). Higher scores indicate higher religiosity.
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)
A continuous scale for pain intensity ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate higher pain intensity.
Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (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)
Qualitative questionnaire will analyze, through a qualitative approach, the effects of essential oil inhalation on the subjective well-being of infertile women.
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 Fertility Quality of Life (FertiQoL) Scores
Time Frame: Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
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.
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)
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.
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)
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.
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)
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.
Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)

Collaborators and Investigators

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

Sponsor

Federal University of Minas Gerais

Investigators

  • Study Chair: Bárbara P Aquino, MSc, Federal University of Minas Gerais
  • Principal Investigator: Jhenifer K Rodrigues, PhD, POTENTIA - Technical, therapeutic, and human development consulting and advisory services
  • Principal Investigator: Rubens L C Tavares, MD, PhD, Federal University of Minas Gerais
  • Study Chair: Ubiratan Brum de Castro, PhD, MD, Federal University of Minas Gerais

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 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEE 94400925.0.0000.0444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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