Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-10-31

Brief Summary

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The purpose of this study is to assess the validity of lavender aromatherapy as a method of anxiolysis prior to a cataract surgery, and to see if this effect will extend intraoperatively to minimize patients' intraoperative medication requirements. The study team plans on enrolling 186 participants.

The investigator team hypothesizes that:

1. Participants will have a lower anxiety score after the intervention
2. Participants will require less intraoperative sedation medication compared to participants that did not have the lavender intervention.
3. A decrease in intraoperative medication requirements will lead to a faster discharge time

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Detailed Description

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All participants will arrive at the Hutchinson Campus on the morning of surgery. After nursing intake, participants will be consented into the study. Vital signs will be recorded, as is part of the typical nursing intake. After the consent is completed, participants will receive the visual analogue scale (VAS) anxiety questionnaire. Participants that are part of the experimental group will then have the Bioesse lavender patch placed on the chest, according to manufacturer recommendations. After the lavender has been in place for 5 minutes, the same VAS anxiety questionnaire will be provided for completion. The control subjects will only receive the initial VAS questionnaire.

After this, all participants will receive the same premedication, including fentanyl and midazolam prior to cataract surgery, and will have monitored anesthesia care (MAC) during the case.

In the second phase of the study, chart review will be completed to monitor the patients' intraoperative sedation requirements . Additionally, demographic data will be taken at this time, including age, race, and sex.

Conditions

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Aromatherapy Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Lavender Aromatherapy Tab

If part of the experimental group, participants will have the Bioesse lavender patch placed on the chest, according to manufacturer recommendations. After the lavender patch has been in place for 5 minutes, participants will receive the same visual analogue scale (VAS) anxiety questionnaire.

Group Type EXPERIMENTAL

Lavender Aromatherapy

Intervention Type OTHER

Participants will have the Bioesse lavender patch placed on the chest, according to manufacturer recommendations.

After the lavender patch has been in place for 5 minutes, the same VAS anxiety questionnaire will be provided

Non-scented Tab

If part of the placebo comparator group, participants will have an unscented tab placed on the chest, according to manufacturer recommendations. Participants in this group will only receive the initial visual analogue scale (VAS) anxiety questionnaire.

Group Type PLACEBO_COMPARATOR

Non-scented Tab

Intervention Type OTHER

A non-scented tab will be placed on the participant's chest, according to manufacturer recommendations. Participants in this group will only receive the initial VAS anxiety questionnaire.

Interventions

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Lavender Aromatherapy

Participants will have the Bioesse lavender patch placed on the chest, according to manufacturer recommendations.

After the lavender patch has been in place for 5 minutes, the same VAS anxiety questionnaire will be provided

Intervention Type OTHER

Non-scented Tab

A non-scented tab will be placed on the participant's chest, according to manufacturer recommendations. Participants in this group will only receive the initial VAS anxiety questionnaire.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Over the age of 18
* ASA (American Society of Anesthesiology) score \<=3
* Patients must be able to consent to participating in the study

Exclusion Criteria

* ASA score \>4
* Patients with a psychiatric diagnosis or who are on psychiatric medication
* Patients with a history of asthma
* Patients with an allergy to lavender
* Patients under an anesthetic plan that has been switched from local anesthesia with sedation to general anesthesia
* VAS score \> 60 pre-operatively (high anxiety score)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes