Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

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

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.

Official Title
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Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

Conditions
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Aromatherapy, Anxiety

Intervention / Treatment
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* Other: Lavender Aromatherapy
* Other: Non-scented Tab


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender Aromatherapy Tab<br>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. | Other: Lavender Aromatherapy<br>* 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<br>|
| Placebo Comparator: Non-scented Tab<br>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. | Other: Non-scented Tab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of lavender aromatherapy on anxiolysis | Patient intra-operative data will be assessed to check dosage of midazolam and fentanyl between the placebo and intervention groups to see if lavender aromatherapy provides intra-operative anxiolysis cataracts surgery | Based on intra-operative time |