Psychological Effects of a Set of Functional Fragrances

Anxiety Clinical Trial

— PSYFRAG  

Official title:

Psychological Effects of a Set of Functional Fragrances - A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06271759
• Other study ID #: PSYFRAG
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Mood
• Stress

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