Anxiety, Aromatherapy, Complementary Therapies, Depression Disorder, Infertility, IVF, Quality of Life, Spirituality, Stress
Conditions
Keywords
Infertility, Female, Aromatherapy, Lavender Oil, Complementary Therapy, Spirituality, IVF, Anxiety, Stress, Depression, In Vitro Fertilization
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.
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
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.
OTHERSynthetic 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.
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Change from Baseline in Insomnia Severity Index (ISI) Scores | 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. |
| Change from Baseline in Flourishing Scale (EFH) Scores | 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. |
| 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) | Measures religious involvement. It contains three subscales: organizational (1-6), non-organizational (1-6), and intrinsic religiosity (3-15). Higher scores indicate higher religiosity. |
| 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) | A continuous scale for pain intensity ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate higher pain intensity. |
| Change from Baseline in General Health Questionnaire (GHQ-12) Scores | 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. |
| Change from Baseline in Qualitative questionnaire | 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. |
Countries
Brazil
Contacts
CONTACTRubens L C Tavares, MD, PhD
CONTACTBárbara P Aquino, MSc
STUDY_CHAIRBárbara P Aquino, MSc
Federal University of Minas Gerais
PRINCIPAL_INVESTIGATORJhenifer K Rodrigues, PhD
POTENTIA - Technical, therapeutic, and human development consulting and advisory services
PRINCIPAL_INVESTIGATORRubens L C Tavares, MD, PhD
Federal University of Minas Gerais
STUDY_CHAIRUbiratan Brum de Castro, PhD, MD
Federal University of Minas Gerais
Outcome results
None listed