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Clinical Trial NCT07480668 for Anxiety, Stress, Depression Disorder, Quality of Life, Aromatherapy, IVF, Complementary Therapies, Spirituality, Infertility is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Aromatherapy for Mental Health Promotion in IVF Patients 120 Randomized
Clinical Trial NCT07480668 is an interventional study for Anxiety, Stress, Depression Disorder, Quality of Life, Aromatherapy, IVF, Complementary Therapies, Spirituality, Infertility that is recruiting. It started on 1 March 2026 with plans to enroll 120 participants. Led by Federal University of Minas Gerais, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
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 th...Show More
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...Show More
Official Title
Aromatherapy for Mental Health Promotion in In Vitro Fertilization Patients: a Randomized Clinical Trial
Conditions
AnxietyStressDepression DisorderQuality of LifeAromatherapyIVFComplementary TherapiesSpiritualityInfertilityOther Study IDs
- CAEE 94400925.0.0000.0444
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-18
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Infertility, Female
Aromatherapy
Lavender Oil
In vitro ferilization
Complementary Therapy
Spirituality
IVF
Anxiety
Stress
Depression
Aromatherapy
Lavender Oil
In vitro ferilization
Complementary Therapy
Spirituality
IVF
Anxiety
Stress
Depression
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalLavender essential oil group 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 n...Show More | 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 s...Show More |
Placebo ComparatorSynthetic lavender aroma group 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. | 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...Show More |
No InterventionControl Group The control group will receive routine care throughout the 4 weeks. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores | The 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 4 (calculated by summing the scores for the relevant items 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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change from Baseline in Fertility Quality of Life (FertiQoL) Scores | The FertiQoL tool evaluates the quality of life in people experiencing fertility problems. Scores are scaled from 0 to 100. Higher scores indicate better quality of life. | Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention) |
Change from Baseline in Insomnia Severity Index (ISI) Scores | The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. 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 | An 8-item measure of psychosocial prosperity. Scores range from 8 to 56. Higher scores indicate more psychological resources and strengths. | 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. 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
- 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.
Federal University of Minas GeraisStudy Responsible Party
Rubens Lene Carvalho Tavares, Principal Investigator, MD, PhD, Federal University of Minas Gerais
Study Central Contact
Contact: Rubens L C Tavares, MD, PhD, +55 31 3409-9764, [email protected]
Contact: Bárbara P Aquino, MSc, [email protected]
1 Study Locations in 1 Countries
Minas Gerais
Department of Obstetrics and Gynecology - Federal University of Minas Gerais - Brazil, Belo Horizonte, Minas Gerais, 30130-100, Brazil
Rubens L C Tavares, MD, PhD, Contact, [email protected]
Bárbara P Aquino, MSc, Contact, [email protected]
Recruiting