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Feasibility of Aromatherapy in an Awake Craniotomy Environment

Feasibility of Aromatherapy in an Awake Craniotomy Environment

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03328143
Enrollment
40
Registered
2017-11-01
Start date
2018-04-03
Completion date
2019-06-12
Last updated
2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pathology

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

DRUGLavender (Lavandula angustifolia)

Lavender (Lavandula angustifolia) is an essential oil.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of Consented PatientsFrom recruitment to end of enrollment periodDetermine the number of eligible patients enrolled and consented
Protocol CompletionFrom 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

MeasureTime frameDescription
Validation of Visual Analogue Scale for Anxiety (VAS-A)8 hoursMeasure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest.
Validation of Visual Analogue Scale for Pain (VAS-P)8 hoursMeasure 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 hoursThis 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

ArmCount
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
Total40

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyCouldn't smell the lavender in the OR1
Overall StudyDeclined3
Overall StudyRequired increased sedation4
Overall StudySurgery cancelled1

Baseline characteristics

CharacteristicTreatment With Lavender
Age, Continuous60 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 typeEG000
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

Primary

Number of Consented Patients

Determine the number of eligible patients enrolled and consented

Time frame: From recruitment to end of enrollment period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lavender GroupNumber of Consented Patients40 Participants
Primary

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)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Lavender GroupProtocol Completion31 Participants
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.

Time frame: 8 hours

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Lavender GroupNumber of Participants Satisfied and Very Satisfied With Pain Treatment Overall.Very Dissatisfied0 Participants
Lavender GroupNumber of Participants Satisfied and Very Satisfied With Pain Treatment Overall.Dissatisfied1 Participants
Lavender GroupNumber of Participants Satisfied and Very Satisfied With Pain Treatment Overall.Uncertain5 Participants
Lavender GroupNumber of Participants Satisfied and Very Satisfied With Pain Treatment Overall.Satisfied12 Participants
Lavender GroupNumber of Participants Satisfied and Very Satisfied With Pain Treatment Overall.Very Satisfied13 Participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Lavender GroupValidation of Visual Analogue Scale for Anxiety (VAS-A)3.1 score on a scaleStandard Deviation 2.968
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

Time frame: 8 hours

ArmMeasureValue (MEAN)Dispersion
Lavender GroupValidation of Visual Analogue Scale for Pain (VAS-P)1.1 score on a scaleStandard Deviation 2.498

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026