NCT05708066

Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Aromatherapy
• Anxiety

Interventions

Type	Name	Description
OTHER	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
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-02-01
• Last updated: 2024-02-08

Locations

1 site across 1 country: United States