Feasibility of Aromatherapy in an Awake Craniotomy Environment

March 11, 2019 updated by: Aurora Health Care
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Health Care, Aurora St. Luke's Medical Center
        • Sub-Investigator:
          • Richard A Rovin, MD
        • Sub-Investigator:
          • Asad Khan, MD
        • Sub-Investigator:
          • Amin Kassam, MD
        • Sub-Investigator:
          • Santhi Konduri, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment with Lavender
Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler.
Drug: Lavender (Lavandula angustifolia)
Lavender (Lavandula angustifolia) is an essential oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of consented patients
Time Frame: 8 hours
Determine the number of eligible patients enrolled and consented
8 hours
Protocol completion
Time Frame: 8 hours
Determine the number of consented patients completing the trial protocol
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of Visual Analogue Scale for Anxiety (VAS-A)
Time Frame: 8 hours
Measure of anxiety, Total Score (0-10)
8 hours
Validation of Visual Analogue Scale for Pain (VAS-P)
Time Frame: 8 hours
Measure of pain, Total Score (0-10)
8 hours
Patient Opinion of Pain Management (POPM) survey
Time Frame: 8 hours
Satisfaction with pain control
8 hours
Analgesic and anxiolytic dosage
Time Frame: 8 hours
Cumulative dose
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurora Health Care

Investigators

  • Principal Investigator: Richard A Rovin, MD, Aurora Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2018

Primary Completion (ANTICIPATED)

February 7, 2020

Study Completion (ANTICIPATED)

February 7, 2020

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (ACTUAL)

November 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17.101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intracranial Pathology

Clinical Trials on Lavender (Lavandula angustifolia)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe