Anxiety, Mood, Stress, Well-Being, Psychological
Conditions
Keywords
Fragrances, Essential Oils, Well-being, Psychological effects, Anxiety, Stress, Depression
Brief summary
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.
Detailed description
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.
Interventions
OTHERFragrance inhalation
Inhalation of fragranced essential oils
Sponsors
IFF (International Flavors & Fragrances)
University of Bucharest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional changes | Up to three months | 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. |
| Affective states - stress | Up to three months | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. |
| Affective states - motivation | Up to three months | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. |
| Affective states - tension | Up to three months | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. |
| Affective states - relaxation | Up to three months | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. |
| Affective states - contentment | Up to three months | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. |
| Affective states - happiness | Up to three months | Changes in momentary affective states are assessed with a Visual Analogue Scale (VAS). VAS are 10-cm long analog scales, scored 0-100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General mental health - Depression | Up to three months | Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21). |
| General mental health - Anxiety | Up to three months | Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21). |
| General mental health - Stress | Up to three months | Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21). |
Countries
Romania
Contacts
Primary ContactCezar Giosan, PhD
Outcome results
None listed