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English Lavender

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.

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

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

Lavender essential oil

Water

Bryan Carroll, MD, PhD

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.

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

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.

Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery

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

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

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

Case Comprehensive Cancer Center

Ginger

Orange

Ginger essential oil (GIN-106) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.

Orange essential oil (ORG-114) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.

Lavender essential oil (LAV-110) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.

Jojoba oil in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. One drop of jojoba oil is on the other three aromatherapy inhalers. Jojoba oil is a "carreir oil" for essential oils which will be used as a comparator and placebo in this study.

Three sniffs of aromatherapy inhaler four times daily for seven days.

Ginger aromatherapy

Orange aromatherapy

Lavender aromatherapy

Jojoba aromatherapy

Julie Ryan Wolf, PhD, MPH

The purpose of this clinical trial is to determine the feasibility and effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy. Aromatherapy is a noninvasive, minimal risk intervention that could potentially alleviate the severity of treatment-related symptoms. This study will evaluate the ability of four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep difficulties, and lack of appetite). Jojoba oil is a " carrier oil" and will act as a placebo comparator in this study. Jojoba oil is present in small amount (1 drop) in the ginger, lavender, and orange aromatherapy inhalers. As part of the study, the participants will be asked to use an aromatherapy inhaler, which resembles a lipstick container, during three chemotherapy cycles. The participants will use the aromatherapy inhaler for 7 consecutive days. The investigators will ask the participants questions regarding demographics, clinical information, current severity of symptoms, and current methods of symptom management. There is a non-intervention baseline cycle during which subjects rate the severity of the seven different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy study cycle. The next two study cycles are intervention cycles using the randomized aromatherapy. The participants will rate the severity of seven different symptoms from 0 to 10 each day the aromatherapy inhaler during one or two chemotherapy cycles (i.e., 7 consecutive days during each chemotherapy cycle). At the end of the study, the participants will be asked about his/her satisfaction with the aromatherapy used during the study. All of these measurements will provide a better understanding of the effectiveness of aromatherapy for symptom management.

This study will evaluate the ability of four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep difficulties, and lack of appetite). Subjects will participate in the study for two or three chemotherapy cycles. The first cycle is a non-intervention baseline cycle during which subjects rate the severity of the seven different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy study cycle. The next one or two cycles are intervention cycle(s) using the assigned randomized aromatherapy. The subjects will rate the severity of seven different symptoms from 0 to 10 each day the aromatherapy inhaler during one or two chemotherapy cycles (i.e., 7 consecutive days during each chemotherapy cycle) and report if they felt the aromatherapy was helping with symptoms compared to the previous cycle. At the end of the study, the participants will be asked about his/her satisfaction with the aromatherapy used during the study. All of these measurements will provide a better understanding of the effectiveness of aromatherapy for symptom management.

Aromatherapy for Integrated Cancer Care

Aromatherapy: An Integrative Option for Symptom Management in Cancer Care

We do not currently have a plant to share individual participant data with other researchers. However, de-identified data will be shared upon request. The data shared will not contain any personal identifiers and will not be able to be linked to study subjects. Study protocol and analysis plans can be shared with other investigators upon request.

Retention rate will be determined by arm.

The compliance rate is the percentage of participants that report using the aromatherapy as described in protocol (i.e., at least three sniffs four times daily).

A composite symptom severity score will be calculated for each day during each Study Cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.

The maximum composite symptom severity score will be the highest severity score across the 6 days for that cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery	NCT06167096	Skin Cancer Skin Carcinoma	Lavender essent... Water	18 Years -	Case Comprehensive Cancer Center
Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery	NCT06167096	Skin Cancer Skin Carcinoma	Lavender essent... Water	18 Years -	Case Comprehensive Cancer Center
Aromatherapy for Integrated Cancer Care	NCT03449511	Cancer	Ginger aromathe... Orange aromathe... Lavender aromat... Jojoba aromathe...	8 Years -	University of Rochester

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