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Aromatherapy
Lavender Aromatherapy for Pre-Surgery Anxiety
N/A
Waitlist Available
Led By Sofia Steinberg, DO
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have an ASA (American Society of Anesthesiology) score less than or equal to 3
Be over the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up based on intra-operative time
Awards & highlights
Study Summary
This trial aims to assess if lavender aromatherapy can reduce anxiety before and during cataract surgery, leading to lower medication use and quicker discharge.
Who is the study for?
This trial is for adults over 18 who are about to have cataract surgery and can consent to the study. They should be in a state of health that's not too risky for anesthesia (ASA score ≤3). People with severe anxiety, psychiatric diagnoses, allergies to lavender, asthma, or those on psychiatric meds cannot join.Check my eligibility
What is being tested?
The study is testing if smelling lavender oil before cataract surgery can help calm patients down more than a non-scented placebo. It also looks at whether this calming effect means they'll need less sedation during the operation and possibly get discharged sooner.See study design
What are the potential side effects?
Lavender aromatherapy is generally considered safe but could cause headaches, allergic reactions or skin irritation in some people. The non-scented tab should not have side effects unless there's an unknown allergy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good enough for surgery according to the ASA score.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ based on intra-operative time
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~based on intra-operative time
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of lavender aromatherapy on anxiolysis
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lavender Aromatherapy TabExperimental Treatment1 Intervention
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.
Group II: Non-scented TabPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,196 Total Patients Enrolled
Sofia Steinberg, DOPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have extreme anxiety before the surgery, as measured by a VAS score higher than 60.My health is good enough for surgery according to the ASA score.I am over 18 years old.My surgery anesthesia plan changed from local with sedation to general.Your overall health condition, as assessed by the ASA score, is very poor.You have a mental health condition.You are allergic to lavender.You have had asthma in the past.I am currently taking medication for a psychiatric condition.
Research Study Groups:
This trial has the following groups:- Group 1: Non-scented Tab
- Group 2: Lavender Aromatherapy Tab
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor welcoming individuals aged 65 and above to take part?
"This research study is open to individuals aged between 18 and 100 years old. Conversely, 79 clinical trials are available for minors and 387 experiments can be accessed by seniors."
Answered by AI
Is enrollment currently open for this investigative study?
"As evidenced by the clinicaltrials.gov database, this particular trial is now closed to enrollment having been initially posted on February 1st 2023 and last updated January 23rd 2023. Nonetheless, there are still 490 other studies actively seeking participants at present."
Answered by AI
Who meets the criteria to participate in this investigation?
"Aromatherapy patients aged 18 to 100, with an ASA score of 3 or lower can sign up for this clinical trial. A minimum age limit and the ability to provide informed consent are both necessary requirements for participation."
Answered by AI
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