Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery

Skin Cancer Clinical Trial

Official title:

Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06167096
• Other study ID #: CASE8Z23
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: Bryan Carroll, MD, PhD
• Phone: 216-844-7834
• Email: Bryan.Carroll[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Mohs Micrographic Surgery (MMS) is a precise and highly effective technique used to treat skin cancers, particularly those with complex or recurrent features. Despite its proven clinical benefits, MMS can be an anxiety-inducing experience for some participants, attributed to the anticipation of the procedure, potential postoperative pain, and the perception of unpleasant odors during the surgical stages; nearly 66% of participants undergoing MMS report unpleasant smells. Anxiety has been shown to adversely affect participants' postoperative recovery and may heighten the perception of pain.

Traditional interventions to manage anxiety in medical settings often involve medication, which may not align with patient preferences. Therefore, there is a need to explore alternative non-pharmacological approaches to create a calming environment during MMS. One such promising intervention is the use of lavender aromatherapy, known for its sedative-like properties and calming effects in various settings. A growing body of research supports the potential benefits of lavender in promoting relaxation and reducing anxiety. Studies conducted on animal models have demonstrated lavender's sedative-like properties, and its active component, linalool, has been shown to inhibit limbic system activity and decrease sympathetic nerve activity.

The inhalation of lavender aroma has been found to influence brain activity, resulting in increased carbohydrates and decreased neurotransmitter activity. Moreover, lavender oil has also been widely studied in dental literature, where it has demonstrated remarkable potential in reducing patient anxiety during various dental procedures.

Another non-pharmacological intervention commonly used to alleviate patient anxiety is music. Music during MMS leads to significant decreases in patient reported anxiety levels, as well as physiological indicators of anxiety. Patient selected music leads to an even greater reduction in anxiety. Despite the positive findings in various medical settings, there is a notable gap in research regarding the application of lavender aromatherapy during MMS and its impact on anxiety levels and unpleasant odor perception. This research aims to investigate the potential of lavender aromatherapy in promoting a calming environment during MMS and its effects on reducing anxiety levels and the perception of unpleasant smells. The study will explore how lavender diffuser use in operating rooms influences patient anxiety levels during the surgical process. By examining the experiences of participants undergoing MMS, this study seeks to provide valuable insights into the efficacy of non-pharmacological interventions, particularly aromatherapy, in reducing anxiety levels and enhancing the overall patient experience during MMS. The findings could contribute to the development of evidence-based interventions to alleviate patient anxiety and improve the overall surgical process for those undergoing MMS

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants with lavender allergies

• Participants with aroma sensitivities

• Participants with anosmia

• Participants with cold or flu symptoms

Related Conditions & MeSH terms

• Skin Cancer
• Skin Carcinoma
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Perception of unpleasant smells	Perception of unpleasant smells will be assessed using a participant satisfaction survey administered post-1 layer with a scale from 0 to 10, 0 being rated as poor/week and 10 being rated as excellent/strong	After MMS procedure post 1 layer