Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery

NCT06167096 | Completed DMC

• 1 other identifier: CASE8Z23
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to improve patient comfort by exploring the potential of lavender aromatherapy in reducing anxiety and unpleasant odor perception during Mohs Micrographic Surgery (MMS). Lavender has been widely studied for its sedative-like properties and calming effects, both in medical and dental settings. By investigating the impact of lavender aromatherapy on patient anxiety levels during MMS, we seek to provide evidence-based insights into non- pharmacological interventions that can enhance the overall comfort and experience of participants.

Conditions

Skin Cancer; Skin Carcinoma

Keywords

Skin Cancer; Lavender Aromatherapy

Outcome Measures

Primary Outcomes (4)

• Change in participant anxiety levels as measured by STAI assessment scale

  Anxiety levels will be measured using the 6-question Spielberg State Trait Anxiety Inventory (STAI) with scale from 1-4, 1 being low and 4 being high

  Before MMS procedure

• Change in participant anxiety levels as measured by STAI assessment scale

  Anxiety levels will be measured using the 6-question Spielberg State Trait Anxiety Inventory (STAI) with scale from 1-4, 1 being low and 4 being high

  After MMS procedure post 1 layer

• Change in participant anxiety levels as measured by VAS assessment scale

  Anxiety levels will be measured using Visual Analog Scale (VAS) of 0 to 100 where 0 being calm and 100 being anxious

  Before MMS procedure

• Change in participant anxiety levels as measured by VAS assessment scale

  Anxiety levels will be measured using Visual Analog Scale (VAS) of 0 to 100 where 0 being calm and 100 being anxious

  After MMS procedure post 1 layer

Secondary Outcomes (1)

• Perception of unpleasant smells

  After MMS procedure post 1 layer

Study Arms (2)

Lavender

EXPERIMENTAL

4 drops of lavender essential oil will be added to an electronic diffusion device with 100ml of water. The device will be turned on 15 minutes before surgery for participants who previously agreed to the study. The device will be turned off after completion of the post- layer questionnaires assessing anxiety and participant experience.

Other: Lavender essential oil

Water

PLACEBO COMPARATOR

On the day of surgery, participants who previously completed the electronic consent will be brought to a room with a diffuser. The diffusers will be turned on 15 minutes before scheduled time of surgery with just water for the control group

Other: Water

Interventions

Lavender essential oil OTHER

Lavender Oil; blend of two (2) pure lavender oil - Lavandula angustifolia from Bulgaria and Lavandula hybrida from France

Lavender

Water OTHER

Water

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• No previous Mohs surgeries
• Currently seen in UH(University Hospitals)Westlake Dermatology Clinic for Mohs surgery
• Mohs surgery of the head and neck

You may not qualify if:

• Participants with lavender allergies
• Participants with aroma sensitivities
• Participants with anosmia
• Participants with cold or flu symptoms

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

lavender oil; Water

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Bryan Carroll, MD, PhD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This study is a single-blinded randomized control study. Days before surgery, participants meeting inclusion criteria will be contacted and an electronic consent will be completed. The intervention shall not be disclosed to participants. Days in which lavender is used in clinic will alternate; participants will be scheduled as normal. participants will therefore be randomly assigned to one of two groups, lavender or control, depending on their surgery date. On the day of surgery, participants who previously completed the electronic consent will be brought to a room with a diffuser. The diffusers will be turned on 15 minutes before scheduled time of surgery with lavender for the intervention group (4 drops per 100ml water) or just water for the control group.

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: July 24, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)