Aromatherapy for Mental Health Promotion in IVF Patients

Federal University of Minas Gerais

Status: Enrolling

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

Treatments: Other: Lavender essential oil Inhalation; Other: Synthetic lavender aroma inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT07480668

CAEE 94400925.0.0000.0444

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Lavender essential oil group

Experimental group

Description:

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.

Treatment:

Other: Lavender essential oil Inhalation

Synthetic lavender aroma group

Placebo Comparator group

Description:

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.

Treatment:

Other: Synthetic lavender aroma inhalation

Control Group

No Intervention group

Description:

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