Feasibility of Aromatherapy in an Awake Craniotomy Environment
Phase: PHASE1
Conditions: Intracranial Pathology
Sponsor: Wake Forest University Health Sciences

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