AnxietyPhase 1NCT03090750
Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure
A Phase 1 study testing Lavender Oil, Bergamot Oil and Water in people with Anxiety and Anxiety Preoperative, run by Wake Forest University Health Sciences.
Trial summary
The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Anxiety Preoperative
- What is being tested?
- Lavender Oil, Bergamot Oil and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2015to Mar 2017
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for Myelogram or IR invasive procedure at investigative site
Who cannot join
- Incapable of giving informed consent
- Requiring pre-medication for scheduled procedure
- Allergy to lavender or bergamot
- Asthma (type of breathing related condition)
- COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)
- Respiratory issues requiring oxygen therapy
About this study
Official title: What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?
The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.
- Conditions
- Anxiety, Anxiety Preoperative
- Being tested
- Lavender Oil, Bergamot Oil, Water
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDrug
Also called Lavender essential oil, Lavender, Lavender flower oil, Lavendula angustifolia
Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
Bergamot OilDrug
Also called Bergamot essential oil, Bergamot, Citrus bergamia
Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
WaterOther
Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
| Study group | Role | What they receive |
|---|---|---|
| Lavender | Experimental | Lavender oil Receives: Drug: Lavender Oil |
| Bergamot | Experimental | Bergamot oil Receives: Drug: Bergamot Oil |
| Water | Placebo comparator | Water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level of patients
Assessed with Amsterdam Preoperative Anxiety and Information Scale
Measured: Immediately prior to invasive radiologic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start16 Jul 2015
- Primary completion19 Dec 2016
- Study completionMar 2017
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 Wake Forest University Health SciencesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine A Becker, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090750
- Sponsor's protocol ID
- 04-14-09B
- Status last verified
- Mar 2018
- First submitted
- 20 Mar 2017
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?
- ClinicalTrials.gov ID
- NCT03090750
- Acronym / sponsor ID
- 04-14-09B
- Conditions
- Anxiety, Anxiety Preoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 16 Jul 2015 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Mar 2017 (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 see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lavender | Experimental | Drug: Lavender OilLavender oil |
| Bergamot | Experimental | Drug: Bergamot OilBergamot oil |
| Water | Placebo comparator | Other: WaterWater |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for Myelogram or IR invasive procedure at investigative site
Key exclusion criteria (6 listed)
- Incapable of giving informed consent
- Requiring pre-medication for scheduled procedure
- Allergy to lavender or bergamot
- Asthma (type of breathing related condition)
- COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)
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 |
|---|---|---|
| Lavender OilAlso: Lavender essential oil, Lavender, Lavender flower oil, Lavendula angustifoliaLavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table | Drug | Lavender |
| Bergamot OilAlso: Bergamot essential oil, Bergamot, Citrus bergamiaBergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table | Drug | Bergamot |
| WaterTap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table | Other | Water |
Primary outcome
Anxiety level of patients
Time frame: Immediately prior to invasive radiologic procedure
Assessed with Amsterdam Preoperative Anxiety and Information Scale
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 23 Mar 2023.
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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.
Christine A Becker, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lavender Oil, Bergamot Oil and Water in people with Anxiety and Anxiety Preoperative, run by Wake Forest University Health Sciences.
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 6 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anxiety level of patients (time frame: Immediately prior to invasive radiologic procedure). 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 23 Mar 2023.