Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

February 6, 2024 updated by: Montefiore Medical Center

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center Hutchinson Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender Aromatherapy Tab
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

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
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Based on intra-operative time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Sofia Steinberg, DO, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-13826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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