Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:16 AM
Study NCT ID:
NCT07480668
Status:
RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatherapy for Mental Health Promotion in IVF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores', 'timeFrame': 'Baseline (Time 0), Week 4 (Time 1, end of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Fertility Quality of Life (FertiQoL) Scores', 'timeFrame': 'Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)', 'description': '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.'}, {'measure': 'Change from Baseline in Insomnia Severity Index (ISI) Scores', 'timeFrame': 'Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)', 'description': '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.'}, {'measure': 'Change from Baseline in Flourishing Scale (EFH) Scores', 'timeFrame': 'Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)', 'description': 'An 8-item measure of psychosocial prosperity. Scores range from 8 to 56. Higher scores indicate more psychological resources and strengths.'}, {'measure': 'Change from Baseline in Duke University Religion Index (DUREL) Scores', 'timeFrame': 'Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)', 'description': 'Measures religious involvement. It contains three subscales: organizational (1-6), non-organizational (1-6), and intrinsic religiosity (3-15). Higher scores indicate higher religiosity.'}, {'measure': 'Change from Baseline in Visual Analog Scale (VAS) for Pain', 'timeFrame': 'Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)', 'description': 'A continuous scale for pain intensity ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate higher pain intensity.'}, {'measure': 'Change from Baseline in General Health Questionnaire (GHQ-12) Scores', 'timeFrame': 'Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)', 'description': '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.'}, {'measure': 'Change from Baseline in Qualitative questionnaire', 'timeFrame': 'Baseline (Time 0, Day 0), Week 4 (Time 1, End of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)', 'description': 'Qualitative questionnaire will analyze, through a qualitative approach, the effects of essential oil inhalation on the subjective well-being of infertile women.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility, Female', 'Aromatherapy', 'Lavender Oil', 'In vitro ferilization', 'Complementary Therapy', 'Spirituality', 'IVF', 'Anxiety', 'Stress', 'Depression'], 'conditions': ['Anxiety', 'Stress', 'Depression Disorder', 'Quality of Life', 'Aromatherapy', 'IVF', 'Complementary Therapies', 'Spirituality', 'Infertility']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n1. Intervention Group: Inhalation of Lavandula angustifolia essential oil.\n2. Placebo Group: Inhalation of synthetic lavender essence.\n3. 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female gender, age over 18 years.\n* Diagnosis of infertility with indication for In Vitro Fertilization (IVF).\n* Patients on the waiting list at HC-UFMG.\n* Agreement not to practice other mind-body or herbal complementary therapies during the study.\n* DASS-21 screening score compatible with at least mild anxiety, stress, and/or depression.\n* No aversion to inhaling essential oil or synthetic lavender essence.\n\nExclusion Criteria:\n\n* Severe neurological, psychiatric, or clinical disorders (e.g., schizophrenia, severe depression) that prevent participation.\n* 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.\n* Known allergy to lavender products.\n* Pregnancy during the study period.\n* Use of essential oils in the last 90 days.'}, 'identificationModule': {'nctId': 'NCT07480668', 'briefTitle': 'Aromatherapy for Mental Health Promotion in IVF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Aromatherapy for Mental Health Promotion in In Vitro Fertilization Patients: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CAEE 94400925.0.0000.0444'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lavender essential oil 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.', 'interventionNames': ['Combination Product: Lavender essential oil Inhalation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Synthetic lavender aroma 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.', 'interventionNames': ['Combination Product: Synthetic lavender aroma inhalation']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group will receive routine care throughout the 4 weeks.'}], 'interventions': [{'name': 'Lavender essential oil Inhalation', 'type': 'COMBINATION_PRODUCT', 'description': "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.", 'armGroupLabels': ['Lavender essential oil group']}, {'name': 'Synthetic lavender aroma inhalation', 'type': 'COMBINATION_PRODUCT', 'description': "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.", 'armGroupLabels': ['Synthetic lavender aroma group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rubens L C Tavares, MD, PhD', 'role': 'CONTACT', 'email': 'rubens.ufmg@gmail.com'}, {'name': 'Bárbara P Aquino, MSc', 'role': 'CONTACT', 'email': 'babiaquino.aromaterapia@gmail.com'}], 'facility': 'Department of Obstetrics and Gynecology - Federal University of Minas Gerais - Brazil', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}], 'centralContacts': [{'name': 'Rubens L C Tavares, MD, PhD', 'role': 'CONTACT', 'email': 'rubens.ufmg@gmail.com', 'phone': '+55 31 3409-9764'}, {'name': 'Bárbara P Aquino, MSc', 'role': 'CONTACT', 'email': 'babiaquino.aromaterapia@gmail.com'}], 'overallOfficials': [{'name': 'Bárbara P Aquino, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Minas Gerais'}, {'name': 'Jhenifer K Rodrigues, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'POTENTIA - Technical, therapeutic, and human development consulting and advisory services'}, {'name': 'Rubens L C Tavares, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Minas Gerais'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Rubens Lene Carvalho Tavares', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}