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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Lavender | Experimental | Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender (Lavandula angustifolia) | Drug | Lavender (Lavandula angustifolia) is an essential oil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Consented Patients | Determine the number of eligible patients enrolled and consented | From recruitment to end of enrollment period |
| Protocol Completion | Determine the number of consented patients completing the trial protocol | From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU) |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of Visual Analogue Scale for Anxiety (VAS-A) | Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest. | 8 hours |
| Validation of Visual Analogue Scale for Pain (VAS-P) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Rovin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Health Care, Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
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40 patients were enrolled, 31 completed the trial
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| ID | Title | Description |
|---|---|---|
| FG000 | Lavender Group | Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The population analyzed are the 31 patients who completed the protocol. All 31 patients received lavender aromatherapy
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Lavender | Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler. Lavender (Lavandula angustifolia): Lavender (Lavandula angustifolia) is an essential oil. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Consented Patients | Determine the number of eligible patients enrolled and consented | Posted | Count of Participants | Participants | From recruitment to end of enrollment period |
|
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From initiation of surgery until discharge from NICU
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lavender Group | Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard A Rovin, MD | Aurora Neuroscience Innovation Institute | 4143851922 | richard.rovin@aurora.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2020 | Dec 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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Measure of pain, Total Score (0-10). Zero is lowest level of pain, 10 thee highest
| 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. | 8 hours |
| Surgery cancelled |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Protocol Completion | Determine the number of consented patients completing the trial protocol | Posted | Count of Participants | Participants | From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU) |
|
|
|
| Secondary | Validation of Visual Analogue Scale for Anxiety (VAS-A) | Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest. | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 8 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 8 hours |
|
|
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| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Satisfied |
|
| Very Satisfied |
|