Clinical trial NCT03328143
Conditions: Intracranial Pathology
Keywords: Craniotomy, anxiety, malignant, cancer, brain tumor
Sponsor: Wake Forest University Health Sciences
Start date: 2018-04-03; Completion date: 2019-06-12
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler.
Interventions: intervention 1: Lavender (Lavandula angustifolia)
Intervention descriptions: intervention 1: Lavender (Lavandula angustifolia) is an essential oil.

Protocol documents:
Prot_SAP_000.pdf: 
Cover letter for NCT03328143 
Protocol ID 17.101 
Protocol title Feasibility of Aromatherapy in an Awake Craniotomy Environment 
Date: November 21, 2020 
 
The document listed as Protocol Synopsis reflects the full Study Protocol and 
Statistical Analysis Plan. As this was a feasibility study, we did not prepare a formal 
study protocol or statistical analysis plan. 
 
 
Thank you, 
 
Richard A Rovin, MD 
 
 


 
 
Protocol Summary 
 
Title 
A Feasibility Study of Lavender Aromatherapy in 
an Awake Craniotomy Environment 
Principal Investigator 
Richard A Rovin, MD 
Research Question(s) 
Is it possible to utilize lavender aromatherapy 
during awake craniotomy 
Study Aims and Hypotheses 
H0: Aromatherapy is technically feasible during 
awake neurosurgical procedures 
Aim 1: To determine the percent of patients who 
would consent to participate 
Aim2: To determine the study completion rate 
for the consented patients 
Primary Endpoint(s) 
1. The number of patients consenting to 
participate 
2. The number of patients completing the 
study 
Secondary Endpoint(s) 
1. Anxiety before and after lavender 
aromatherapy intervention 
2. Pain before and after lavender 
aromatherapy intervention 
3. Patient’s expectation of lavender 
aromatherapy 
4. Patient satisfaction with lavender 
aromatherapy 
Study Design 
Open label, single arm 
Study Population 
Inclusion Criteria: an adult patient undergoing 
clinically indicated cranial neurosurgical 
procedure 
Exclusion Criteria: allergy to lavender 
(Lavandula angustifolia); aversion to lavender 
scent; history of asthma or COPD; pregnancy; 
history of contact dermatitis following exposure 
to cosmetic fragrances 
Treatment 
Inhalation of lavender from a nasal inhaler, prior 
to the start of surgery and every 30 minutes 
thereafter, or if requested by the patient 
Method of Randomization 
N/A 
Sample Size Calculation 
N/A 
Outcome Measures 
VAS-A, VAS-P, expectancy questionnaire, POPM 
tool 
Statistical Analysis 
Demographic characteristics were noted using 
appropriate descriptive statistics for all 


categorical and continuous variables. As both 
VAS-A and VAS-P were assessed multiple times 
for the same patients, mean scores of these 
measures were compared using the repeated 
measures analysis of variance (ANOVA), 
including multivariate analysis of variance 
(MANOVA) tests in the general linear model. 
Expectancy questionnaire responses were 
analyzed using a 2-sided, paired t-test. Mean 
POPM scores were compared using an 
independent t-test. An alpha of 0.05 was used for 
all statistical tests, and all analyses were done 
using SAS® 9.4 (SAS Institute Inc., Cary, NC).  
Interim Analysis 
N/A 
Subgroup Analysis 
N/A 
Safety 
This trial used the U.S. Department of Health and 
Human Services’ Common Terminology Criteria 
for Adverse Events, Version 4.0 (published May 
28, 2009; revised June 14, 2010) for toxicity and 
adverse event reporting. 
Closure 
The results will be submitted to medical meetings and 
peer reviewed journals