StressPSYFRAGNCT06271759
Psychological Effects of a Set of Essential Oils
A study testing Fragrance inhalation in people with Stress and Anxiety, run by University of Bucharest at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Well-Being, Psychological
- What is being tested?
- Fragrance inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRomania
- Study dates
- 4 Apr 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (at least 18 years old)
Who cannot join
- Allergies to Essential Oils
- Medical conditions that could have an effect on sense of smell
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
University of Bucharest
Bucharest, 050663
Cezar Giosan, PhD, +40730908050, giosan@outlook.com
About this study
Official title: Psychological Effects of a Set of Essential Oils - A Randomized Interventional 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.
Read the 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.
- Conditions
- Stress, Anxiety, Well-Being, Psychological, Mood
- Being tested
- Fragrance inhalation
- Keywords
- Fragrances, Essential Oils, Well-being, Psychological effects, Anxiety, Stress, Depression
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragrance inhalationOther
Inhalation of fragranced essential oils
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to three months
Secondary outcomes (3)
General mental health - Depression
Depressive symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Measured: Up to three months
General mental health - Anxiety
Anxiety symptoms are assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Measured: Up to three months
General mental health - Stress
Stress is assessed with the Depression, Anxiety and Stress Scale (DASS-21).
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start4 Apr 2024
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bucharest
- Sponsor type
- University, hospital or other
- Collaborators
- IFF (International Flavors & Fragrances)
- Responsible party
- Principal investigator, Cezar Giosan, University of Bucharest
- Investigators
- Cezar Giosan, PhD, Principal investigator, University of Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271759
- Sponsor's protocol ID
- PSYFRAG
- Acronym
- PSYFRAG
- Status last verified
- Jun 2024
- First submitted
- 14 Feb 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Effects of a Set of Essential Oils - A Randomized Interventional Trial
- ClinicalTrials.gov ID
- NCT06271759
- Acronym / sponsor ID
- PSYFRAG / PSYFRAG
- Conditions
- Stress, Anxiety, Well-Being, Psychological, Mood
- Keywords
- Fragrances, Essential Oils, Well-being, Psychological effects, Anxiety, Stress, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BucharestUniversity, hospital or other
- Collaborators
- IFF (International Flavors & Fragrances)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fragrance 1 Group | Experimental | Other: Fragrance 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 2 Group | Experimental | Other: Fragrance 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 Group | Experimental | Other: Fragrance 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 Group | Experimental | Other: Fragrance 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (at least 18 years old)
Key exclusion criteria (2 listed)
- Allergies to Essential Oils
- Medical conditions that could have an effect on sense of smell
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fragrance inhalationInhalation of fragranced essential oils | Other | Fragrance 1 Group, Fragrance 2 Group, Fragrance 3 Group, Fragrance 4 Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
General mental health - Depression
Time frame: Up to three months
General mental health - Anxiety
Time frame: Up to three months
General mental health - Stress
Time frame: Up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cezar Giosan, PhD principal investigator
University of Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fragrance inhalation in people with Stress and Anxiety, run by University of Bucharest at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cezar Giosan, PhD (+40730908050, giosan@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affective states - relaxation (time frame: Up to three months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.