An interventional study of Fragrance inhalation in Stress, Anxiety and Well-Being, Psychological, sponsored by University of Bucharest. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by University of Bucharest · Not applicable, Interventional, and Basic science
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Bucharest is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
At-home administration of one of the four active stimuli (fragrances), according to the following protocol: 1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being. 2. Participants will inhale the fragranced stimulus for approximately 10 minutes. 3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes. 4. Participants will complete a series of psychological scales (post-measurements). 5. Participants will repeat this protocol one week apart.
Other: Fragrance inhalation
At-home administration of one of the four active stimuli (fragrances), according to the following protocol: 1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being. 2. Participants will inhale the fragranced stimulus for approximately 10 minutes. 3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes. 4. Participants will complete a series of psychological scales (post-measurements). 5. Participants will repeat this protocol one week apart.
Other: Fragrance inhalation
At-home administration of one of the four active stimuli (fragrances), according to the following protocol: 1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being. 2. Participants will inhale the fragranced stimulus for approximately 10 minutes. 3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes. 4. Participants will complete a series of psychological scales (post-measurements). 5. Participants will repeat this protocol one week apart.
Other: Fragrance inhalation
At-home administration of one of the four active stimuli (fragrances), according to the following protocol: 1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being. 2. Participants will inhale the fragranced stimulus for approximately 10 minutes. 3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes. 4. Participants will complete a series of psychological scales (post-measurements). 5. Participants will repeat this protocol one week apart.
Other: Fragrance inhalation
At-home administration of the neutral/no-odor stimulus, according to the following protocol: 1. Participants will complete a series of psychological scales (pre-measurements), tapping into mood, affective states, well-being. 2. Participants will inhale the non-fragranced stimulus for approximately 10 minutes. 3. After the completion of step 2, participants will engage in a neutral activity for about 15 minutes. 4. Participants will complete a series of psychological scales (post-measurements). 5. Participants will repeat this protocol one week apart.
Inhalation of fragranced essential oils
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to three months
General mental health - Depression
Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Time frame: Up to three months
General mental health - Anxiety
Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Time frame: Up to three months
General mental health - Stress
Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Time frame: Up to three months
Plan to share: No
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University of Bucharest