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| Name | Class |
|---|---|
| IFF (International Flavors & Fragrances) | UNKNOWN |
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The goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. The main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being.
Participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart.
The potential beneficial effects of a set of Essential Oils (EO) are being tested in the form of a Randomized Clinical Trial (RCT). There are five conditions: a control (receiving a neutral/no-odor stimulus) and four active groups (receiving one of the four EO).
The study is a within-subjects/between-subjects design with five arms and involves comparisons between pre-intervention and post-intervention between: (a) Initial psychological states of the participants, and (b) After inhalation of the stimuli. Participants will be randomly allocated to one of the five experimental arms.
For medium effect sizes assumed (f = 0.25), 5 groups and two measurements in time (pre and post stimulus administration) a minimum of 80 subjects total sample size is needed.
Affective states (relaxation, contentment, happiness, motivation, tension), as well as data on mood; depression, anxiety, and stress will be assessed.
Data about familiarity, pleasantness and intensity of the stimuli will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fragrance 1 Group | Experimental | At-home administration of one of the four active stimuli (fragrances), according to the following protocol:
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| Fragrance 2 Group | Experimental | At-home administration of one of the four active stimuli (fragrances), according to the following protocol:
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| Fragrance 3 Group | Experimental | At-home administration of one of the four active stimuli (fragrances), according to the following protocol:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fragrance inhalation | Other | Inhalation of fragranced essential oils |
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| Measure | Description | Time Frame |
|---|---|---|
| Affective states - relaxation | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. | Up to three months |
| Affective states - contentment | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. | Up to three months |
| Affective states - happiness | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. | Up to three months |
| Affective states - stress | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. | Up to three months |
| Affective states - motivation | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. | Up to three months |
| Affective states - tension | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. | Up to three months |
| Emotional changes | Changes in emotional patterns are assessed based on their intensity, one of the three components of emotional reactivity from the Multidimensional Emotion Questionnaire (MEQ). The questionnaire represents a reliable general measure of emotional experience, focusing on 10 discrete emotions (5 positive and 5 negative). Intensity is rated on a 5-Likert scale that ranges from 1 - Very low to 5 - Very high. |
| Measure | Description | Time Frame |
|---|---|---|
| General mental health - Depression | Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21). | Up to three months |
| General mental health - Anxiety | Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cezar Giosan, PhD | Contact | +40730908050 | giosan@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Cezar Giosan, PhD | University of Bucharest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bucharest | Recruiting | Bucharest | 050663 | Romania |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| Fragrance 4 Group | Experimental | At-home administration of one of the four active stimuli (fragrances), according to the following protocol:
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| No Fragrance Group | No Intervention | At-home administration of the neutral/no-odor stimulus, according to the following protocol:
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| Up to three months |
| Up to three months |
| General mental health - Stress | Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21). | Up to three months |