Aromatherapy for Mental Health Promotion in IVF Patients

Official title

Aromatherapy for Mental Health Promotion in In Vitro Fertilization Patients: a Randomized Clinical Trial

Overview

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:

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).

Interventions

• 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 t
• 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

Primary outcome measures

• 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)]

Secondary outcome measures (7)

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Department of Obstetrics and Gynecology - Federal University of Minas Gerais - Brazil — Belo Horizonte

Identifiers

NCT: NCT07480668 · CAEE 94400925.0.0000.0444

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗