Feasibility of Aromatherapy in an Awake Craniotomy Environment
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedStudy Start
First participant enrolled
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2019
CompletedResults Posted
Study results publicly available
August 5, 2024
CompletedOctober 3, 2024
July 1, 2024
1.2 years
October 27, 2017
February 12, 2020
October 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Consented Patients
Determine the number of eligible patients enrolled and consented
From recruitment to end of enrollment period
Protocol Completion
Determine the number of consented patients completing the trial protocol
From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)
Secondary Outcomes (3)
Validation of Visual Analogue Scale for Anxiety (VAS-A)
8 hours
Validation of Visual Analogue Scale for Pain (VAS-P)
8 hours
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall.
8 hours
Study Arms (1)
Treatment with Lavender
EXPERIMENTALLavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler.
Interventions
Lavender (Lavandula angustifolia) is an essential oil.
Eligibility Criteria
You may qualify if:
- Any adult patient aged 18 and older undergoing awake cranial neurosurgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aurora Health Care, Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard A Rovin, MD
- Organization
- Aurora Neuroscience Innovation Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Richard A Rovin, MD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2017
First Posted
November 1, 2017
Study Start
April 3, 2018
Primary Completion
June 12, 2019
Study Completion
June 12, 2019
Last Updated
October 3, 2024
Results First Posted
August 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share