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Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

Primary Purpose

Aromatherapy, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender Aromatherapy
Non-scented Tab
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aromatherapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Montefiore Medical Center Hutchinson Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lavender Aromatherapy Tab

Non-scented Tab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effect of lavender aromatherapy on anxiolysis
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

Secondary Outcome Measures

Full Information

First Posted
January 23, 2023
Last Updated
September 18, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05708066
Brief Title
Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
Official Title
Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Participants will have a lower anxiety score after the intervention Participants will require less intraoperative sedation medication compared to participants that did not have the lavender intervention. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aromatherapy, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lavender Aromatherapy Tab
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-scented Tab
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lavender Aromatherapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non-scented Tab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of lavender aromatherapy on anxiolysis
Description
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
Time Frame
Based on intra-operative time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Steinberg, DO
Phone
7326891253
Email
sosteinb@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katelyn Champagne, MD
Phone
9146560767
Email
kchampagne@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Steinberg, DO
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center Hutchinson Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Steinberg, DO
Phone
732-689-1253
First Name & Middle Initial & Last Name & Degree
Sofia Steinberg, DO
First Name & Middle Initial & Last Name & Degree
Katelyn Champagne, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24978117
Citation
Abend R, Dan O, Maoz K, Raz S, Bar-Haim Y. Reliability, validity and sensitivity of a computerized visual analog scale measuring state anxiety. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):447-53. doi: 10.1016/j.jbtep.2014.06.004. Epub 2014 Jun 18.
Results Reference
background
PubMed Identifier
23476690
Citation
Cho MY, Min ES, Hur MH, Lee MS. Effects of aromatherapy on the anxiety, vital signs, and sleep quality of percutaneous coronary intervention patients in intensive care units. Evid Based Complement Alternat Med. 2013;2013:381381. doi: 10.1155/2013/381381. Epub 2013 Feb 17.
Results Reference
background
PubMed Identifier
30205934
Citation
Jaruzel CB, Gregoski M, Mueller M, Faircloth A, Kelechi T. Aromatherapy for Preoperative Anxiety: A Pilot Study. J Perianesth Nurs. 2019 Apr;34(2):259-264. doi: 10.1016/j.jopan.2018.05.007. Epub 2018 Sep 8.
Results Reference
background
PubMed Identifier
31743795
Citation
Kang HJ, Nam ES, Lee Y, Kim M. How Strong is the Evidence for the Anxiolytic Efficacy of Lavender?: Systematic Review and Meta-analysis of Randomized Controlled Trials. Asian Nurs Res (Korean Soc Nurs Sci). 2019 Dec;13(5):295-305. doi: 10.1016/j.anr.2019.11.003. Epub 2019 Nov 16.
Results Reference
background
PubMed Identifier
10589606
Citation
Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.
Results Reference
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Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

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