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Clinical Trials/NCT05708066
NCT05708066
Withdrawn
Not Applicable

Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

Montefiore Medical Center1 site in 1 countryJanuary 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aromatherapy
Sponsor
Montefiore Medical Center
Locations
1
Primary Endpoint
Effect of lavender aromatherapy on anxiolysis
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2024
End Date
October 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Effect of lavender aromatherapy on anxiolysis

Time Frame: 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

Study Sites (1)

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