Aromatherapy for Mental Health Promotion in IVF Patients

NCT07480668 | Recruiting

• 1 other identifier: CAEE 94400925.0.0000.0444
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Stress; Depression Disorder; Quality of Life; Aromatherapy; IVF; Complementary Therapies; Spirituality; Infertility

Keywords

Infertility, Female; Aromatherapy; Lavender Oil; Complementary Therapy; Spirituality; IVF; Anxiety; Stress; Depression; In Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)

• Change from Baseline in Insomnia Severity Index (ISI) Scores

  Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)

• Change from Baseline in Flourishing Scale (EFH) Scores

  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

  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

  Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)

Study Arms (3)

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.

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.

Other: Synthetic lavender aroma inhalation

Control Group

NO INTERVENTION

The control group will receive routine care throughout the 4 weeks.

Interventions

Lavender essential oil Inhalation OTHER

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.

Lavender essential oil group

Synthetic lavender aroma inhalation OTHER

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.

Synthetic lavender aroma group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Department of Obstetrics and Gynecology - Federal University of Minas Gerais - Brazil

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Infertility; Infertility, Female; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Behavioral Symptoms; Behavior

Study Officials

• Bárbara P Aquino, MSc

  Federal University of Minas Gerais

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Ubiratan Brum de Castro, PhD, MD

  Federal University of Minas Gerais

  STUDY CHAIR

Central Study Contacts

Rubens L C Tavares, MD, PhD

CONTACT

+55 31 3409-9764; rubens.ufmg@gmail.com

Bárbara P Aquino, MSc

CONTACT

babiaquino.aromaterapia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BR (1)