Aromatherapy for Mental Health Promotion in IVF Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFederal University of Minas Gerais

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lavender essential oil Inhalation

    Other intervention

    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.

  • Synthetic lavender aroma inhalation

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Lavender essential oil groupExperimental treatment 1 intervention
Group B: Synthetic lavender aroma groupPlacebo comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Time 0), Week 4 (Time 1, end of Intervention) and Week 8 (Time 2, 4 weeks post-intervention)

Secondary outcomes

1

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.

Time frame
Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
2

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.

Time frame
Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
3

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.

Time frame
Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)
4

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.

Time frame
Baseline (Day 0), Week 4 (End of Intervention) and Week 8 (4 weeks post-intervention)

Other outcomes

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