Clinical trial NCT05708066: Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
Official title: Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aromatherapy
Anxiety
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Effect of lavender aromatherapy on anxiolysis
timeFrame: Based on intra-operative time
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center Hutchinson Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sofia Steinberg, DO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.