MedPath

Psychological Effects of a Set of Essential Oils

Not Applicable
Recruiting
Conditions
Stress
Anxiety
Well-Being, Psychological
Mood
Interventions
Other: Fragrance inhalation
Registration Number
NCT06271759
Lead Sponsor
University of Bucharest
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Fragrance 2 GroupFragrance inhalationAt-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.
Fragrance 4 GroupFragrance inhalationAt-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.
Fragrance 1 GroupFragrance inhalationAt-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.
Fragrance 3 GroupFragrance inhalationAt-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.
Primary Outcome Measures
NameTimeMethod
Affective states - relaxationUp 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.

Affective states - contentmentUp 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.

Affective states - happinessUp 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.

Affective states - motivationUp 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.

Affective states - stressUp 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.

Affective states - tensionUp 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.

Emotional changesUp 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.

Secondary Outcome Measures
NameTimeMethod
General mental health - AnxietyUp to three months

Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).

General mental health - StressUp to three months

Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21).

General mental health - DepressionUp to three months

Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).

Trial Locations

Locations (1)

University of Bucharest

🇷🇴

Bucharest, Romania

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