Intracranial Pathology
Conditions
Keywords
Craniotomy, anxiety, malignant, cancer, brain tumor
Brief 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. 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.
Interventions
Lavender (Lavandula angustifolia) is an essential oil.
Sponsors
Study design
Eligibility
Inclusion criteria
* Any adult patient aged 18 and older undergoing awake cranial neurosurgery
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Consented Patients | From recruitment to end of enrollment period | Determine the number of eligible patients enrolled and consented |
| Protocol Completion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validation of Visual Analogue Scale for Anxiety (VAS-A) | 8 hours | Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest. |
| Validation of Visual Analogue Scale for Pain (VAS-P) | 8 hours | Measure of pain, Total Score (0-10). Zero is lowest level of pain, 10 thee highest |
| Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. | 8 hours | 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. |
Countries
United States
Participant flow
Pre-assignment details
40 patients were enrolled, 31 completed the trial
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Couldn't smell the lavender in the OR | 1 |
| Overall Study | Declined | 3 |
| Overall Study | Required increased sedation | 4 |
| Overall Study | Surgery cancelled | 1 |
Baseline characteristics
| Characteristic | Treatment With Lavender | — |
|---|---|---|
| Age, Continuous | 60 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Number of Consented Patients
Determine the number of eligible patients enrolled and consented
Time frame: From recruitment to end of enrollment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lavender Group | Number of Consented Patients | 40 Participants |
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lavender Group | Protocol Completion | 31 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lavender Group | Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. | Very Dissatisfied | 0 Participants |
| Lavender Group | Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. | Dissatisfied | 1 Participants |
| Lavender Group | Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. | Uncertain | 5 Participants |
| Lavender Group | Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. | Satisfied | 12 Participants |
| Lavender Group | Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. | Very Satisfied | 13 Participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender Group | Validation of Visual Analogue Scale for Anxiety (VAS-A) | 3.1 score on a scale | Standard Deviation 2.968 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lavender Group | Validation of Visual Analogue Scale for Pain (VAS-P) | 1.1 score on a scale | Standard Deviation 2.498 |