Clinical trial NCT03328143: Feasibility of Aromatherapy in an Awake Craniotomy Environment
Official title: Feasibility of Aromatherapy in an Awake Craniotomy Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intracranial Pathology
Keywords: Craniotomy, anxiety, malignant, cancer, brain tumor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Consented Patients
timeFrame: From recruitment to end of enrollment period
measure: Protocol Completion
timeFrame: From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)
Secondary outcomes:
measure: Validation of Visual Analogue Scale for Anxiety (VAS-A)
timeFrame: 8 hours
measure: Validation of Visual Analogue Scale for Pain (VAS-P)
timeFrame: 8 hours
measure: Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall.
timeFrame: 8 hours
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Health Care, Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Richard A Rovin, MD
role: PRINCIPAL_INVESTIGATOR
References: