Intracranial PathologyPhase 1NCT03328143
Feasibility of Aromatherapy in an Awake Craniotomy Environment
A Phase 1 study testing Lavender (Lavandula angustifolia) in people with Intracranial Pathology, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function during tumor resection. Awake craniotomy is increasingly utilized as it has several advantages over a traditional general anesthetic technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pathology
- What is being tested?
- Lavender (Lavandula angustifolia)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2018to 12 Jun 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient aged 18 and older undergoing awake cranial neurosurgery
Who cannot join
- Allergy or sensitivity to the aromatherapy agent (Lavender)
- Aversion to lavender scent
- History of asthma, chronic obstructive pulmonary disease (COPD)
- History of contact dermatitis following exposure to cosmetic fragrances
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Health Care, Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
About this study
Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function during tumor resection. Awake craniotomy is increasingly utilized as it has several advantages over a traditional general anesthetic technique. Though many patients tolerate awake cranial surgery well, recent studies found that roughly 30% of patients experience moderate to severe pain and anxiety, while 50% report moderate fear and 11% report severe fear. Therefore, alternative methods to mitigate pain, anxiety, and fear are needed. In this study, the investigators will employ lavender aromatherapy to reduce anxiety and improve the satisfaction with pain control.
Read the detailed description
The lavender aromatherapy trial protocol was developed in conjunction with the Aurora Health Care (AHC) Integrative Medicine Department and Certified Clinical Aromatherapy Practitioners (CCAP). Participating patients received standard of care intraoperative analgesic and anxiolytic management plus lavender aromatherapy. Lavender scent was administered via nasal inhaler. The lavender essential oil, base oil, and nasal inhaler were provided by AHC Integrative Medicine Department to ensure standardization across all patients. The nasal inhaler was prepared with 15 gtts (drops) of lavender essential oil and 4 gtts (drops) of the base oil (grapeseed oil). A CCAP from Integrative Medicine provided training on the delivery of lavender aromatherapy to all study team members. This person consulted on the participation of the first three subjects and was present in the operating room (OR) to oversee administration of lavender aromatherapy. The CCAP was also available for consultation during the course of the study, as needed.
A dedicated OR nurse, neuropsychologist, or neuropsychometrist oversaw administration of lavender aromatherapy to subjects. They monitored the subject during study participation and were prepared to discontinue the trial if they felt continued participation was detrimental to the patient. Lavender aromatherapy was administered for up to five minutes using the nasal inhaler at designated time points (preoperative, induction) and every 30 minutes during the surgery. Although the majority of the time OR personnel administered the aromatherapy, some patients were able to and chose to self-administer. Additional lavender aromatherapy treatments were provided at any time upon request. During non-use periods, the nasal inhaler was capped and sealed. If the subject was unable to verbally request the research team member to hold the nasal inhaler under their nose, the subject's participation in the study was terminated. Additionally, subjects were free to discontinue administration of aromatherapy at any time during their participation in the study. The timing and reason of discontinuation of lavender aromatherapy was recorded.
- Conditions
- Intracranial Pathology
- Being tested
- Lavender (Lavandula angustifolia)
- Keywords
- Craniotomy, anxiety, malignant, cancer, brain tumor
- Medical subject headings
- Anxiety Disorders, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender (Lavandula angustifolia)Drug
Lavender (Lavandula angustifolia) is an essential oil.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Lavender | Experimental | Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler. Receives: Drug: Lavender (Lavandula angustifolia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Consented Patients
Determine the number of eligible patients enrolled and consented
Measured: From recruitment to end of enrollment period
Protocol Completion
Determine the number of consented patients completing the trial protocol
Measured: From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)
Secondary outcomes (3)
Validation of Visual Analogue Scale for Anxiety (VAS-A)
Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest.
Measured: 8 hours
Validation of Visual Analogue Scale for Pain (VAS-P)
Measure of pain, Total Score (0-10). Zero is lowest level of pain, 10 thee highest
Measured: 8 hours
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall.
This is a 5 point Likert scale for the question, "How satisfied are you with your pain treatment overall?" The responses are very dissatisfied, dissatisfied, uncertain, satisfied, very satisfied. The responses are summarized in the data table: Number of Participants Very Dissatisfied with Pain Treatment Overall, Number of Participants Dissatisfied with Pain Treatment Overall, Number of Participants Uncertain About Pain Treatment Overall, Number of Participants Satisfied with Pain Treatment Overall, Number of Participants Very Satisfied with Pain Treatment Overall. A single participant can provide only one response to the question so that the outcome measure Number of Participants Very Dissatisfied with Pain Treatment Overall, for example, means the number of participants very dissatisfied with pain treatment overall. There are not multiple assessments, there are 5 possible responses to the question and, again, only one response is permitted for one patient.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start3 Apr 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial PathologyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard A Rovin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328143
- Sponsor's protocol ID
- 17.101
- Status last verified
- Jul 2024
- First submitted
- 27 Oct 2017
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Aromatherapy in an Awake Craniotomy Environment
- ClinicalTrials.gov ID
- NCT03328143
- Acronym / sponsor ID
- 17.101
- Conditions
- Intracranial Pathology
- Keywords
- Craniotomy, anxiety, malignant, cancer, brain tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Awake craniotomy for tumor surgery allows for mapping of speech, motor and sensory function during tumor resection. Awake craniotomy is increasingly utilized as it has several advantages over a traditional general anesthetic technique. Though many patients tolerate awake cranial surgery well, recent studies found that roughly 30% of patients experience moderate to severe pain and anxiety, while 50% report moderate fear and 11% report severe fear. Therefore, alternative methods to mitigate pain, anxiety, and fear are needed. In this study, the investigators will employ lavender aromatherapy to reduce anxiety and improve the satisfaction with pain control.
Detailed description
The lavender aromatherapy trial protocol was developed in conjunction with the Aurora Health Care (AHC) Integrative Medicine Department and Certified Clinical Aromatherapy Practitioners (CCAP). Participating patients received standard of care intraoperative analgesic and anxiolytic management plus lavender aromatherapy. Lavender scent was administered via nasal inhaler. The lavender essential oil, base oil, and nasal inhaler were provided by AHC Integrative Medicine Department to ensure standardization across all patients. The nasal inhaler was prepared with 15 gtts (drops) of lavender essential oil and 4 gtts (drops) of the base oil (grapeseed oil). A CCAP from Integrative Medicine provided training on the delivery of lavender aromatherapy to all study team members. This person consulted on the participation of the first three subjects and was present in the operating room (OR) to oversee administration of lavender aromatherapy. The CCAP was also available for consultation during the course of the study, as needed.
A dedicated OR nurse, neuropsychologist, or neuropsychometrist oversaw administration of lavender aromatherapy to subjects. They monitored the subject during study participation and were prepared to discontinue the trial if they felt continued participation was detrimental to the patient. Lavender aromatherapy was administered for up to five minutes using the nasal inhaler at designated time points (preoperative, induction) and every 30 minutes during the surgery. Although the majority of the time OR personnel administered the aromatherapy, some patients were able to and chose to self-administer. Additional lavender aromatherapy treatments were provided at any time upon request. During non-use periods, the nasal inhaler was capped and sealed. If the subject was unable to verbally request the research team member to hold the nasal inhaler under their nose, the subject's participation in the study was terminated. Additionally, subjects were free to discontinue administration of aromatherapy at any time during their participation in the study. The timing and reason of discontinuation of lavender aromatherapy was recorded.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Lavender | Experimental | Drug: Lavender (Lavandula angustifolia)Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient aged 18 and older undergoing awake cranial neurosurgery
Key exclusion criteria (5 listed)
- Allergy or sensitivity to the aromatherapy agent (Lavender)
- Aversion to lavender scent
- History of asthma, chronic obstructive pulmonary disease (COPD)
- History of contact dermatitis following exposure to cosmetic fragrances
- Pregnancy
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 (Lavandula angustifolia)Lavender (Lavandula angustifolia) is an essential oil. | Drug | Treatment with Lavender |
Primary outcome
Number of Consented Patients
Time frame: From recruitment to end of enrollment period
Determine the number of eligible patients enrolled and consented
Protocol Completion
Time frame: From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)
Determine the number of consented patients completing the trial protocol
3 secondary outcomes
Validation of Visual Analogue Scale for Anxiety (VAS-A)
Time frame: 8 hours
Validation of Visual Analogue Scale for Pain (VAS-P)
Time frame: 8 hours
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall.
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Richard A Rovin, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lavender (Lavandula angustifolia) in people with Intracranial Pathology, run by Wake Forest University Health Sciences 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 5 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 3 Oct 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 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.
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?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Consented Patients (time frame: From recruitment to end of enrollment period). 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 3 Oct 2024.