Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

Not Applicable

Withdrawn

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Lavender Aromatherapy Tab	Lavender Aromatherapy	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.
Non-scented Tab	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.

Primary Outcome Measures

Name	Time	Method
Effect of lavender aromatherapy on anxiolysis	Based on intra-operative time	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

Secondary Outcome Measures

Name	Time	Method

Locations (1): Montefiore Medical Center Hutchinson Campus
🇺🇸
Bronx, New York, United States

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