Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

NCT05708066 | Withdrawn

• 1 other identifier: 2022-13826
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 1.Participants will have a lower anxiety score after the intervention
2. 2.Participants will require less intraoperative sedation medication compared to participants that did not have the lavender intervention.
3. 3.A decrease in intraoperative medication requirements will lead to a faster discharge time

Conditions

Aromatherapy; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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

  Based on intra-operative time

Study Arms (2)

Lavender Aromatherapy Tab

EXPERIMENTAL

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

Non-scented Tab

PLACEBO COMPARATOR

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

Interventions

Lavender Aromatherapy OTHER

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

Lavender Aromatherapy Tab

Non-scented Tab OTHER

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.

Non-scented Tab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18
• ASA (American Society of Anesthesiology) score \<=3
• Patients must be able to consent to participating in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center Hutchinson Campus

The Bronx, New York, 10461, United States

Location

Related Publications (5)

• 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.

  PMID: 24978117 BACKGROUND

• 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.

  PMID: 23476690 BACKGROUND

• 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.

  PMID: 30205934 BACKGROUND

• 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.

  PMID: 31743795 BACKGROUND

• Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.

  PMID: 10589606 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sofia Steinberg, DO

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)