Psychological Effects of a Set of Essential Oils

NCT ID: NCT06271759

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-04

Study Completion Date

2024-11-15

Brief Summary

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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

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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.

Conditions

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Stress Anxiety Well-Being, Psychological Mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Fragrance 1 Group

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.

Group Type EXPERIMENTAL

Fragrance inhalation

Intervention Type OTHER

Inhalation of fragranced essential oils

Fragrance 2 Group

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.

Group Type EXPERIMENTAL

Fragrance inhalation

Intervention Type OTHER

Inhalation of fragranced essential oils

Fragrance 3 Group

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.

Group Type EXPERIMENTAL

Fragrance inhalation

Intervention Type OTHER

Inhalation of fragranced essential oils

Fragrance 4 Group

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.

Group Type EXPERIMENTAL

Fragrance inhalation

Intervention Type OTHER

Inhalation of fragranced essential oils

No Fragrance Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fragrance inhalation

Inhalation of fragranced essential oils

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IFF (International Flavors & Fragrances)

UNKNOWN

Sponsor Role collaborator

University of Bucharest

OTHER

Sponsor Role lead

Responsible Party

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Cezar Giosan

Associate Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cezar Giosan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bucharest

Locations

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University of Bucharest

Bucharest, , Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Cezar Giosan, PhD

Role: CONTACT

+40730908050

Facility Contacts

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Cezar Giosan, PhD

Role: primary

+40730908050

Other Identifiers

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PSYFRAG

Identifier Type: -

Identifier Source: org_study_id

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