AnxietyNCT03445130
A Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
A study testing Lavandula Angustifolia oil (LO), Michelia Alba Leaf oil (MA) and Almond oil (AO) in people with Anxiety, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of lavender aromatherapy on preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Anxiety
- What is being tested?
- Lavandula Angustifolia oil (LO), Michelia Alba Leaf oil (MA) and Almond oil (AO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 23 Sep 2020
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, older than 18, American Society of Anesthesiologists (ASA) classification I-III, undergoing elective breast surgery on Tisch 10th floor Day Surgery. Cancer patients are included.
Who cannot join
- History of asthma, bronchitis, COPD, contact dermatitis to cosmetic fragrances, positive patch test, pregnancy, and significant laboratory abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
The purpose of this study is to determine the effects of lavender aromatherapy on preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study participants will then be randomized into one of four groups; either they will receive 2 drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA) or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face mask for 15 minutes. Linalool makes up ~30% of Lavandula Angustifolia oil and is believed to be its most active anti-anxiety component. Before and after treatment, anxiety level will be measured using the Spielberger State-Trait Anxiety Inventory.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavandula Angustifolia oil (LO)Other
two drops on the inside of an oxygen face mask for 15 minutes.
Michelia Alba Leaf oil (MA)Other
two drops on the inside of an oxygen face mask for 15 minutes.
Almond oil (AO)Other
two drops on the inside of an oxygen face mask for 15 minutes.
WaterOther
two drops on the inside of an oxygen face mask for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lavandula Angustifolia oil (LO) | Active comparator | 2 Drops in Oxygen Mask Receives: Other: Lavandula Angustifolia oil (LO) |
| Michelia Alba Leaf oil (MA) | Active comparator | 2 Drops in Oxygen Mask Receives: Other: Michelia Alba Leaf oil (MA) |
| Almond oil (AO) | Active comparator | 2 Drops in Oxygen Mask Receives: Other: Almond oil (AO) |
| Water | Active comparator | 2 Drops in Oxygen Mask Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in anxiety as measured by the change in baseline STAI scores
Spielberger State-Trait Anxiety Inventory (STAI) is a self-reported instrument. It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. State anxiety can be defined as a transient momentary emotional status that results from situational stress.
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start10 Apr 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Wajda, MD, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445130
- Sponsor's protocol ID
- 16-01844
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2018
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification. Researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Placebo-Controlled Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
- ClinicalTrials.gov ID
- NCT03445130
- Acronym / sponsor ID
- 16-01844
- Conditions
- Anxiety
- Keywords
- Preoperative Anxiety, Breast Surgery, Lavender Aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 26 Feb 2018 (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 determine the effects of lavender aromatherapy on preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study participants will then be randomized into one of four groups; either they will receive 2 drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA) or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face mask for 15 minutes. Linalool makes up ~30% of Lavandula Angustifolia oil and is believed to be its most active anti-anxiety component. Before and after treatment, anxiety level will be measured using the Spielberger State-Trait Anxiety Inventory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lavandula Angustifolia oil (LO) | Active comparator | Other: Lavandula Angustifolia oil (LO)2 Drops in Oxygen Mask |
| Michelia Alba Leaf oil (MA) | Active comparator | Other: Michelia Alba Leaf oil (MA)2 Drops in Oxygen Mask |
| Almond oil (AO) | Active comparator | Other: Almond oil (AO)2 Drops in Oxygen Mask |
| Water | Active comparator | Other: Water2 Drops in Oxygen Mask |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women, older than 18, American Society of Anesthesiologists (ASA) classification I-III, undergoing elective breast surgery on Tisch 10th floor Day Surgery. Cancer patients are included.
Key exclusion criteria (1 listed)
- History of asthma, bronchitis, COPD, contact dermatitis to cosmetic fragrances, positive patch test, pregnancy, and significant laboratory abnormalities.
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 |
|---|---|---|
| Lavandula Angustifolia oil (LO)two drops on the inside of an oxygen face mask for 15 minutes. | Other | Lavandula Angustifolia oil (LO) |
| Michelia Alba Leaf oil (MA)two drops on the inside of an oxygen face mask for 15 minutes. | Other | Michelia Alba Leaf oil (MA) |
| Almond oil (AO)two drops on the inside of an oxygen face mask for 15 minutes. | Other | Almond oil (AO) |
| Watertwo drops on the inside of an oxygen face mask for 15 minutes. | Other | Water |
Primary outcome
Reduction in anxiety as measured by the change in baseline STAI scores
Time frame: 20 Minutes
Spielberger State-Trait Anxiety Inventory (STAI) is a self-reported instrument. It was designed to assess levels of state anxiety and traint anxiety, through 40 items scored by a likert-scale. State anxiety can be defined as a transient momentary emotional status that results from situational stress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification. Researchers who provide a methodologically sound proposal.
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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.
Michael Wajda, MD principal investigator
New York Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavandula Angustifolia oil (LO), Michelia Alba Leaf oil (MA) and Almond oil (AO) in people with Anxiety, run by NYU Langone Health 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Feb 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in anxiety as measured by the change in baseline STAI scores (time frame: 20 Minutes). 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 18 Feb 2022.