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Feasibility of Aromatherapy in an Awake Craniotomy Environment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03328143
Recruitment Status : Unknown
Verified March 2019 by Aurora Health Care.
Recruitment status was:  Recruiting
First Posted : November 1, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Aurora Health Care

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.

Condition or disease Intervention/treatment Phase
Intracranial Pathology Drug: Lavender (Lavandula angustifolia) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Aromatherapy in an Awake Craniotomy Environment
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : February 7, 2020
Estimated Study Completion Date : February 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Number of consented patients [ Time Frame: 8 hours ]
    Determine the number of eligible patients enrolled and consented

  2. Protocol completion [ Time Frame: 8 hours ]
    Determine the number of consented patients completing the trial protocol


Secondary Outcome Measures :
  1. Validation of Visual Analogue Scale for Anxiety (VAS-A) [ Time Frame: 8 hours ]
    Measure of anxiety, Total Score (0-10)

  2. Validation of Visual Analogue Scale for Pain (VAS-P) [ Time Frame: 8 hours ]
    Measure of pain, Total Score (0-10)

  3. Patient Opinion of Pain Management (POPM) survey [ Time Frame: 8 hours ]
    Satisfaction with pain control

  4. Analgesic and anxiolytic dosage [ Time Frame: 8 hours ]
    Cumulative dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, COPD
  • History of contact dermatitis following exposure to cosmetic fragrances
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328143


Contacts
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Contact: Gary Dennison, CIP 414-385-1913 gary.dennison@aurora.org
Contact: Carol Tutino, RN,MS,CCRC 414-649-5526 carol.tutino@aurora.org

Locations
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United States, Wisconsin
Aurora Health Care, Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Lynda Yanny    414-649-6685    lynda.yanny@aurora.org   
Principal Investigator: George Bobustuc, MD         
Sub-Investigator: Richard A Rovin, MD         
Sub-Investigator: Asad Khan, MD         
Sub-Investigator: Amin Kassam, MD         
Sub-Investigator: Santhi Konduri, PhD         
Sponsors and Collaborators
Aurora Health Care
Investigators
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Principal Investigator: Richard A Rovin, MD Aurora Health Care
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Responsible Party: Aurora Health Care
ClinicalTrials.gov Identifier: NCT03328143    
Other Study ID Numbers: 17.101
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Aurora Health Care:
Craniotomy, anxiety, malignant, cancer, brain tumor