Psychological Effects of a Set of Essential Oils (PSYFRAG)

University of Bucharest

Status: Enrolling

Conditions: Mood; Anxiety; Well-Being, Psychological; Stress

Treatments: Other: Fragrance inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT06271759

PSYFRAG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 5 patient groups

Fragrance 1 Group

Experimental group

Description:

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.

Treatment:

Other: Fragrance inhalation

Fragrance 2 Group

Experimental group

Description:

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.

Treatment:

Other: Fragrance inhalation

Fragrance 3 Group

Experimental group

Description:

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.

Treatment:

Other: Fragrance inhalation

Fragrance 4 Group

Experimental group

Description:

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.

Treatment:

Other: Fragrance inhalation

No Fragrance Group

No Intervention group

Description:

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.