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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2024
Source University of Bucharest
Contact Cezar Giosan, PhD
Phone +40730908050
Email giosan@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fragrance inhalation
Inhalation of fragranced essential oils

Locations

Country Name City State
Romania University of Bucharest Bucharest

Sponsors (2)

Lead Sponsor Collaborator
University of Bucharest IFF (International Flavors & Fragrances)

Country where clinical trial is conducted

Romania, 

Outcome

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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