Feasibility of Aromatherapy in an Awake Craniotomy Environment

Intracranial Pathology Clinical Trial

Official title:

Feasibility of Aromatherapy in an Awake Craniotomy Environment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03328143
• Other study ID #: 17.101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 3, 2018
• Est. completion date: February 7, 2020

Study information

• Verified date: March 2019
• Source: Aurora Health Care
• Contact: Gary Dennison, CIP
• Phone: 414-385-1913
• Email: gary.dennison[@]aurora.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, COPD

• History of contact dermatitis following exposure to cosmetic fragrances

• Pregnancy

Related Conditions & MeSH terms

• Intracranial Pathology

Intervention

Drug:
• Lavender (Lavandula angustifolia)
Lavender (Lavandula angustifolia) is an essential oil.

Locations

Country	Name	City	State
United States	Aurora Health Care, Aurora St. Luke's Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of consented patients	Determine the number of eligible patients enrolled and consented	8 hours
Primary	Protocol completion	Determine the number of consented patients completing the trial protocol	8 hours
Secondary	Validation of Visual Analogue Scale for Anxiety (VAS-A)	Measure of anxiety, Total Score (0-10)	8 hours
Secondary	Validation of Visual Analogue Scale for Pain (VAS-P)	Measure of pain, Total Score (0-10)	8 hours
Secondary	Patient Opinion of Pain Management (POPM) survey	Satisfaction with pain control	8 hours
Secondary	Analgesic and anxiolytic dosage	Cumulative dose	8 hours