Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

Montefiore Medicine Academic Health System

Status: Withdrawn

Conditions: Aromatherapy; Anxiety

Treatments: Other: Lavender Aromatherapy; Other: Non-scented Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05708066

2022-13826

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups, including a placebo group

Lavender Aromatherapy Tab

Experimental group

Description:

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.

Treatment:

Other: Lavender Aromatherapy

Non-scented Tab

Placebo Comparator group

Description:

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.

Treatment:

Other: Non-scented Tab