Trial Outcomes & Findings for Feasibility of Aromatherapy in an Awake Craniotomy Environment (NCT NCT03328143)

Results Overview

Determine the number of eligible patients enrolled and consented

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

From recruitment to end of enrollment period

Results posted on

2024-10-03

Participant Flow

40 patients were enrolled, 31 completed the trial

Participant milestones

Participant milestones
Measure	Lavender Group Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Overall Study STARTED	40
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Lavender Group Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Overall Study Declined	3
Overall Study Required increased sedation	4
Overall Study Couldn't smell the lavender in the OR	1
Overall Study Surgery cancelled	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Lavender n=40 Participants Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals using a nasal inhaler. Lavender (Lavandula angustifolia): Lavender (Lavandula angustifolia) is an essential oil.
Age, Continuous	60 years n=40 Participants
Sex: Female, Male Female	21 Participants n=40 Participants
Sex: Female, Male Male	19 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants

PRIMARY outcome

Timeframe: From recruitment to end of enrollment period

Determine the number of eligible patients enrolled and consented

Outcome measures

Outcome measures
Measure	Lavender Group n=40 Participants Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Number of Consented Patients	40 Participants

PRIMARY outcome

Timeframe: From the preoperative evaluation through the post operative evaluation in the Neurosurgical Intensive Care Unit (NICU)

Determine the number of consented patients completing the trial protocol

Outcome measures

Outcome measures
Measure	Lavender Group n=40 Participants Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Protocol Completion	31 Participants

SECONDARY outcome

Timeframe: 8 hours

Measure of anxiety, Total Score (0-10). Zero is lowest anxiety, 10 is highest.

Outcome measures

Outcome measures
Measure	Lavender Group n=31 Participants Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Validation of Visual Analogue Scale for Anxiety (VAS-A)	3.1 score on a scale Standard Deviation 2.968

SECONDARY outcome

Timeframe: 8 hours

Measure of pain, Total Score (0-10). Zero is lowest level of pain, 10 thee highest

Outcome measures

Outcome measures
Measure	Lavender Group n=31 Participants Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Validation of Visual Analogue Scale for Pain (VAS-P)	1.1 score on a scale Standard Deviation 2.498

SECONDARY outcome

Timeframe: 8 hours

This is a 5 point Likert scale for the question, "How satisfied are you with your pain treatment overall?" The responses are very dissatisfied, dissatisfied, uncertain, satisfied, very satisfied. The responses are summarized in the data table: Number of Participants Very Dissatisfied with Pain Treatment Overall, Number of Participants Dissatisfied with Pain Treatment Overall, Number of Participants Uncertain About Pain Treatment Overall, Number of Participants Satisfied with Pain Treatment Overall, Number of Participants Very Satisfied with Pain Treatment Overall. A single participant can provide only one response to the question so that the outcome measure Number of Participants Very Dissatisfied with Pain Treatment Overall, for example, means the number of participants very dissatisfied with pain treatment overall. There are not multiple assessments, there are 5 possible responses to the question and, again, only one response is permitted for one patient.

Outcome measures

Outcome measures
Measure	Lavender Group n=31 Participants Lavender (Lavandula angustifolia) aromatherapy will be administered at regular intervals, or upon request, using a nasal inhaler.
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. Very Dissatisfied	0 Participants
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. Dissatisfied	1 Participants
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. Uncertain	5 Participants
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. Satisfied	12 Participants
Number of Participants Satisfied and Very Satisfied With Pain Treatment Overall. Very Satisfied	13 Participants

Adverse Events

Lavender Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard A Rovin, MD

Aurora Neuroscience Innovation Institute

Phone: 4143851922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place