Aromatherapy for Mental Health Promotion in In Vitro Fertilization Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores
研究概览
简要总结
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.
详细描述
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:
- Intervention Group: Inhalation of Lavandula angustifolia essential oil.
- Placebo Group: Inhalation of synthetic lavender essence.
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lavender 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 night before sleeping, for four weeks.
干预措施: Lavender essential oil Inhalation (Other)
Synthetic 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.
干预措施: Synthetic lavender aroma inhalation (Other)
Control Group
The control group will receive routine care throughout the 4 weeks.
结局指标
主要结局
Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) Scores
时间窗: 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.
次要结局
- 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))
- Change from Baseline in Insomnia Severity Index (ISI) Scores(Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention))
- Change from Baseline in Flourishing Scale (EFH) Scores(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(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 Duke University Religion Index (DUREL) Scores(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(Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention))
- 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))
研究者
Rubens Lene Carvalho Tavares
MD, PhD
Federal University of Minas Gerais