StressNCT04495842
The Effect of Aromatherapy on COVID-19-induced Anxiety
A study testing Essential Oil Blend in people with Stress and Covid19, run by Nutraceuticals Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Essential Oil Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Mar 2022
- 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
- Otherwise healthy
- Documented COVID-19 exposure, suspected infection, or diagnosed infection
- Has been tested for or diagnosed with COVID-19
- adults age 18-65 living in the US
- understands and agrees to comply with study procedures
- provides informed consent
Who cannot join
- Smoker in household
- Pregnant or may become pregnant
- Difficulty breathing
- Pain or pressure in the chest
- Confusion
- Hospitalization
Show all 9Show fewer
- Asthma, COPD, or other respiratory condition
- demonstrated inability to comply with study procedures
- has participated in an interventional clinical study within 31 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Franklin Health Research Center
Franklin, Tennessee, 37067
Jessie Hawkins, PhD, 615-642-1919, j.hawkins@franklinhealth.org
About this study
The purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.
Read the detailed description
After being informed about the study, participants who provide consent will be randomized to one of two groups. Participants will receive one of two aromas to inhale with one being active and the other a control comparison.
- Being tested
- Essential Oil Blend, Control Blend
- Keywords
- aromatherapy, essential oils, environmental health
- Medical subject headings
- COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Oil BlendOther
5 drops of on a tester strip
Control BlendOther
5 drops on a tester strip
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants. Receives: Other: Essential Oil Blend |
| Control | Placebo comparator | Participants receive an inert comparison to inhale for 15 minutes. Receives: Other: Control Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.
Measured: Baseline and at 15 minutes
Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.
Measured: Baseline and at 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessie Hawkins, PhD, Principal investigator, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495842
- Sponsor's protocol ID
- 20-7-5600
- Status last verified
- Jul 2021
- First submitted
- 30 Jul 2020
- Last updated
- 2 Aug 2021
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on COVID-19-induced Anxiety
- ClinicalTrials.gov ID
- NCT04495842
- Acronym / sponsor ID
- 20-7-5600
- Keywords
- aromatherapy, essential oils, environmental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 3 Aug 2020 (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 purpose of this study is to assess the potential for a non-invasive sensory based intervention to reduce the stress associated with a COVID-19 diagnosis.
Detailed description
After being informed about the study, participants who provide consent will be randomized to one of two groups. Participants will receive one of two aromas to inhale with one being active and the other a control comparison.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Essential Oil BlendParticipants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants. |
| Control | Placebo comparator | Other: Control BlendParticipants receive an inert comparison to inhale for 15 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Otherwise healthy
- Documented COVID-19 exposure, suspected infection, or diagnosed infection
- Has been tested for or diagnosed with COVID-19
- adults age 18-65 living in the US
- understands and agrees to comply with study procedures
Key exclusion criteria (9 listed)
- Smoker in household
- Pregnant or may become pregnant
- Difficulty breathing
- Pain or pressure in the chest
- Confusion
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 |
|---|---|---|
| Essential Oil Blend5 drops of on a tester strip | Other | Intervention |
| Control Blend5 drops on a tester strip | Other | Control |
Primary outcome
Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
Time frame: Baseline and at 15 minutes
The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.
Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
Time frame: Baseline and at 15 minutes
This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- 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.
Jessie Hawkins, PhD principal investigator
Nutraceuticals Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil Blend in people with Stress and Covid19, run by Nutraceuticals Research Institute at 1 site in United States.
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 6 inclusion and 9 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 2 Aug 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 PI (6152613116, info@franklinhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes (time frame: Baseline and at 15 minutes). The study lists 2 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 2 Aug 2021.