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临床试验/NCT06785649
NCT06785649尚未招募不适用

The Effect of Lavender Herbal Tea on the Mental Health of Individuals With Misophonia: A Randomized Clinical Trial

Sakarya University0 个研究点目标入组 60 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Misophonia Scale

研究概览

简要总结

Misophonia is a disorder characterized by a high level of annoyance with certain sounds. Exposure to these sounds causes physical symptoms characterized by anger, aggression, helplessness, overwhelm, and stimulation of the sympathetic nervous system. These emotional and physical reactions can lead to a decline in family relationships, work and school productivity, withdrawal from social relationships, and even suicide. There is limited empirical evidence evaluating the efficacy of therapeutic approaches to misophonia. This limited empirical evidence consists of pharmacological agents such as selective serotonin reuptake inhibitors, stimulants, antipsychotics, and β-Blockers, as well as cognitive behavioral therapy, acceptance and commitment therapy, and dialectical behavior therapy. Complementary therapies are important because of their potential efficacy, tolerability, possible non-interference, and low cost. The fact that lavender has anxiolytic, antidepressant, neuroprotective, and anti-inflammatory properties may affect the emotional and physical responses elicited by misophonia. Therefore, within the scope of the study, misophonia individuals will be divided into two groups; one group will use lavender tea for 14 days and the other group will form a waiting list. The study data will be collected by 'Information Collection Form', 'Misophonia Scale', 'Beck Depression Inventory-II', 'Anxiety Rating Scale', and 'Trait Anger Scale'. SPSS 25.0 software will be used to analyze the data obtained from the research. Considering the limitations of therapeutic approaches for misophonia, testing the effectiveness of lavender in reducing misophonia symptoms will make an important contribution to the literature.

详细描述

Misophonia is a disorder of vocal sensitivity characterized by unusual discomfort with certain sounds. Typical triggers are sounds produced by humans, particularly oral and nasal sounds. These sounds include chewing, slurping, breathing, keyboard sounds, or pen clicks. When individuals with misophonia are exposed to triggers, stimulation of the sympathetic nervous system and emotional distress are observed. Exposure to triggers creates irritation, desire to avoid stimuli, anger, aggression, helplessness, and overwhelm. Stimulation of the sympathetic nervous system leads to physical symptoms such as hypertonia, sweating, and tachycardia. The discomfort and stress caused by misophonia can lead to increased anxiety levels in individuals. At the same time, the emotional distress and discomfort associated with misophonia can trigger depressive symptoms and increase the risk of depression. Concomitant anxiety and depression can worsen the existing symptoms of misophonia and lead to a reduced quality of life.

There is limited empirical evidence evaluating the efficacy of therapeutic approaches to misophonia. Current treatment approaches include cognitive behavioral therapy, acceptance and commitment therapy, and psychotherapies derived from dialectical behavior therapy. Due to the small number of randomized controlled trials, the efficacy of the protocols used in the treatment of misophonia remains unclear. Due to limited resources, problems such as limited access to psychotherapies and early withdrawal from treatment are also observed. Other treatment approaches include pharmacological agents such as selective serotonin reuptake inhibitors (SSRIs), stimulants, antipsychotics, and β-Blockers. Complementary therapies are used due to their potential efficacy, tolerability, possible non-interference, and low cost. Lavender, a complementary treatment intervention, is considered to have anxiolytic, antidepressant, neuroprotective, and anti-inflammatory properties. Lavender is known to positively affect memory, provide alertness, and improve feelings of well-being. Thus, it is seen as an effective herbal medicine intervention in reducing anxiety and depression. Reducing concomitant anxiety and depression may contribute to the improvement of the symptoms of misophonia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Reporting at least three trigger sounds
  • Assessed by a specialist psychiatric nurse and a psychiatrist as humophonia based on the diagnostic criteria for humophonia established by Schröder et al. (2013)
  • Individuals aged 18 and over

排除标准

  • Allergy to any herbal tea, food or medicine
  • Psychiatric illness or chronic illness
  • Taking psychiatric medication (such as anxiolytics, and antidepressants)
  • Regular use of medication (such as antihypertensive, antidiabetic)
  • Regular use of herbal teas or complementary medicines
  • Tinnitus and/or hyperacusis

结局指标

主要结局

Misophonia Scale

时间窗: Within the first 24 hours after 14 days of lavender tea

It is a 30-item self-report scale aiming to assess the severity of misophonia. The scale is a 5-point Likert-type scale and is graded between 1: Strongly agree and 5: Strongly disagree to 5: Strongly disagree. The total score range is 30 - 150. As the score obtained from the scale decreases, the level of misophonia severity decreases.

次要结局

  • Beck Depression Inventory-II (BDI-II)(Within the first 24 hours after 14 days of lavender tea)
  • Anxiety Assessment Scale(Within the first 24 hours after 14 days of lavender tea)
  • Trait Anger Scale (SL-Anger)(Within the first 24 hours after 14 days of lavender tea)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Sponsor

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