NCT06271759

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

February 14, 2024

Last Update Submit

June 19, 2024

Conditions

StressAnxietyWell-Being, PsychologicalMood

Keywords

FragrancesEssential OilsWell-beingPsychological effectsAnxietyStressDepression

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • General mental health - Depression

    Up to three months

  • General mental health - Anxiety

    Up to three months

  • General mental health - Stress

    Up to three months

Study Arms (5)

Fragrance 1 Group

EXPERIMENTAL

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

Fragrance 2 Group

EXPERIMENTAL

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

Fragrance 3 Group

EXPERIMENTAL

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

Fragrance 4 Group

EXPERIMENTAL

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

No Fragrance Group

NO INTERVENTION

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.

Interventions

Fragrance inhalationOTHER

Inhalation of fragranced essential oils

Fragrance 1 GroupFragrance 2 GroupFragrance 3 GroupFragrance 4 Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (at least 18 years old)

You may not qualify if:

  • Allergies to Essential Oils
  • Medical conditions that could have an effect on sense of smell

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bucharest

Bucharest, 050663, Romania

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-BeingDepression

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehaviorBehavioral Symptoms

Study Officials

  • Cezar Giosan, PhD

    University of Bucharest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cezar Giosan, PhD

CONTACT

+40730908050giosan@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 22, 2024

Study Start

April 4, 2024

Primary Completion

November 15, 2024

Study Completion

November 15, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)