Psychological Effects of a Set of Functional Fragrances (PSYFRAG)

April 6, 2024 updated by: Cezar Giosan, University of Bucharest

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Bucharest, Romania, 050663
        • Recruiting
        • University of Bucharest
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Fragrance inhalation
Inhalation of fragranced essential oils
Experimental: 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.
Other: Fragrance inhalation
Inhalation of fragranced essential oils
Experimental: 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.
Other: Fragrance inhalation
Inhalation of fragranced essential oils
Experimental: 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.
Other: Fragrance inhalation
Inhalation of fragranced essential oils
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affective states - relaxation
Time Frame: Up to three months
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
Affective states - contentment
Time Frame: Up to three months
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
Affective states - happiness
Time Frame: Up to three months
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
Affective states - stress
Time Frame: Up to three months
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
Affective states - motivation
Time Frame: Up to three months
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
Affective states - tension
Time Frame: Up to three months
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
Emotional changes
Time Frame: Up to three months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
General mental health - Depression
Time Frame: Up to three months
Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Up to three months
General mental health - Anxiety
Time Frame: Up to three months
Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Up to three months
General mental health - Stress
Time Frame: Up to three months
Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Up to three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bucharest

Collaborators

IFF (International Flavors & Fragrances)

Investigators

  • Principal Investigator: Cezar Giosan, PhD, University of Bucharest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSYFRAG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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