Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-26 @ 8:28 PM
Study NCT ID:
NCT05708066
Status:
WITHDRAWN
Last Update Posted:
2024-02-08
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never approved by the Albert Einstein College of Medicine IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: