Clinical trial NCT06271759: Psychological Effects of a Set of Essential Oils
Official title: Psychological Effects of a Set of Essential Oils - A Randomized Interventional Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Well-Being, Psychological
Mood
Keywords: Fragrances
Essential Oils
Well-being
Psychological effects
Anxiety
Stress
Depression
Lead sponsor: University of Bucharest
Sponsor class: OTHER
Collaborators: name: IFF (International Flavors & Fragrances)
First posted: 2024-02-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Affective states - relaxation
timeFrame: Up to three months
measure: Affective states - contentment
timeFrame: Up to three months
measure: Affective states - happiness
timeFrame: Up to three months
measure: Affective states - stress
timeFrame: Up to three months
measure: Affective states - motivation
timeFrame: Up to three months
measure: Affective states - tension
timeFrame: Up to three months
measure: Emotional changes
timeFrame: Up to three months
Secondary outcomes:
measure: General mental health - Depression
timeFrame: Up to three months
measure: General mental health - Anxiety
timeFrame: Up to three months
measure: General mental health - Stress
timeFrame: Up to three months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: University of Bucharest
Study officials:
affiliation: University of Bucharest
name: Cezar Giosan, PhD
role: PRINCIPAL_INVESTIGATOR
References: