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临床试验/NCT06167096
NCT06167096已完成不适用

Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery

Case Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2024年7月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Change in participant anxiety levels as measured by VAS assessment scale

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Lavender essential oil (Other)

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

干预措施: Water (Other)

结局指标

主要结局

Change in participant anxiety levels as measured by VAS assessment scale

时间窗: After MMS procedure post 1 layer

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

Change in participant anxiety levels as measured by STAI assessment scale

时间窗: After MMS procedure post 1 layer

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

Change in participant anxiety levels as measured by STAI assessment scale

时间窗: Before MMS procedure

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

Change in participant anxiety levels as measured by VAS assessment scale

时间窗: Before MMS procedure

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

次要结局

  • Perception of unpleasant smells(After MMS procedure post 1 layer)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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