A Phase 1 interventional study of Lavender (Lavandula angustifolia) in Intracranial Pathology, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Other
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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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 200 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler.
Drug: Lavender (Lavandula angustifolia)
Lavender (Lavandula angustifolia) is an essential oil.
Number of Consented Patients
Determine the number of eligible patients enrolled and consented
Time frame: From recruitment to end of enrollment period
Protocol Completion
Determine the number of consented patients completing the trial protocol
Time frame: From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)
Validation of Visual Analogue Scale for Anxiety (VAS-A)
Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest.
Time frame: 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
Time frame: 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.
Time frame: 8 hours
| Milestone | Lavender Group |
|---|---|
| Started | 40 |
| Completed | 31 |
| Not completed | 9 |
| Withdrew: Declined | 3 |
| Withdrew: Required increased sedation | 4 |
| Withdrew: Couldn't smell the lavender in the or | 1 |
| Withdrew: Surgery cancelled | 1 |
Determine the number of eligible patients enrolled and consented
| Participants | Lavender Group |
|---|---|
| Number of Consented Patients | 40 |
Determine the number of consented patients completing the trial protocol
| Participants | Lavender Group |
|---|---|
| Protocol Completion | 31 |
Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest.
| score on a scale | Lavender Group |
|---|---|
| Validation of Visual Analogue Scale for Anxiety (VAS-A) | 3.1 ± 2.968 |
Measure of pain, Total Score (0-10). Zero is lowest level of pain, 10 thee highest
| score on a scale | Lavender Group |
|---|---|
| Validation of Visual Analogue Scale for Pain (VAS-P) | 1.1 ± 2.498 |
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.
| Participants | Lavender Group |
|---|---|
| Very Dissatisfied | 0 |
| Dissatisfied | 1 |
| Uncertain | 5 |
| Satisfied | 12 |
| Very Satisfied | 13 |
Collected over From initiation of surgery until discharge from NICU. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lavender Group | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
The population analyzed are the 31 patients who completed the protocol. All 31 patients received lavender aromatherapy
| Age, Continuous(years) | Treatment With Lavender |
|---|---|
| Mean | 60 (22 to 80) |
| Sex: Female, Male(Participants) | Treatment With Lavender |
|---|---|
| Female | 21 |
| Male | 19 |
| Race and Ethnicity Not Collected(Participants) | Treatment With Lavender |
|---|
| Region of Enrollment(participants) | Treatment With Lavender |
|---|---|
| United States | 40 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Jun 2019, 14 months.
Results were first posted in Aug 2024, 5 years 1 month after primary completion.
Of 52 non-industry phase 1 interventional studies under Anxiety Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 32. This study's 14 months is below that.
Counting every sponsor, half of 71 studies reached it within 14 months; a quarter within 7 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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