Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Control Group | No Intervention | The control group will receive routine care throughout the 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Fertility Quality of Life (FertiQoL) Scores | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubens L C Tavares, MD, PhD | Contact | +55 31 3409-9764 | rubens.ufmg@gmail.com | |
| Bárbara P Aquino, MSc | Contact | babiaquino.aromaterapia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology - Federal University of Minas Gerais - Brazil | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D007246 | Infertility |
| D007247 | Infertility, Female |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention) |
| Change from Baseline in Insomnia Severity Index (ISI) Scores | 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 | 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 Duke University Religion Index (DUREL) Scores | 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 | 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 General Health Questionnaire (GHQ-12) Scores | 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) |
| Change from Baseline in Qualitative questionnaire | 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) |
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |