Anxiety Clinical Trial
— PSYFRAGOfficial title:
Psychological Effects of a Set of Functional Fragrances - A Randomized Clinical Trial
NCT number | NCT06271759 |
Other study ID # | PSYFRAG |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2024 |
Est. completion date | August 15, 2024 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | August 15, 2024 |
Est. primary completion date | August 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Adults (at least 18 years old) Exclusion Criteria: - Allergies to Essential Oils - Medical conditions that could have an effect on sense of smell |
Country | Name | City | State |
---|---|---|---|
Romania | University of Bucharest | Bucharest |
Lead Sponsor | Collaborator |
---|---|
University of Bucharest | IFF (International Flavors & Fragrances) |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | Up to three months | |
Secondary | General mental health - Depression | Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21). | Up to three months | |
Secondary | General mental health - Anxiety | Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21). | Up to three months | |
Secondary | General mental health - Stress | Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21). | Up to three months |
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