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临床试验/NCT05042778
NCT05042778已完成不适用

Is Auriculotherapy Responsable for Improvements on Anxiety Students' Prior and After Examinations?

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Change on Spielberger's State-Trait-Anxiety Inventory (STAI)

研究概览

简要总结

As the investigators have shown before, there was a tendency for a reduction of anxiety levels on university students after 30 minutes, with auriculotherapy treatment before examinations have started. However, the effect was effective and clinically significant after 48 hours comparing auriculotherapy with placebo and no treatment. In this sense, the investigators intend to perform a new study with a large sample and introduce a new hypothesis. So, this study aims to detect the clinical effect of two auriculotherapy techniques on the anxiety levels of university students.

详细描述

To treat anxiety, conventional medicine relies on medicines such as benzodiazepines, antidepressants, barbiturates, and antihistamines. However, several authors have reported western medicine cannot resolve all anxiety diseases and the risk of side effects, resistance to pharmacological treatments affects approximately one in three patients with anxiety disorders.

Alternatively, auriculotherapy is a technique similar to reflexology. It is speculated the technique might work in anxiety because groups of pluripotent cells contain information from the whole organism creating regional organization centres representing different parts of the body, through the recruitment of more cortex cells dedicated to specific body areas. Thus reflex points in the ear can incite body responses by the stimulation of reticular formation and the sympathetic and parasympathetic nervous systems. The information that comes from the thermal, Algic and proprioceptive stimuli are transmitted from the auricular pavilion by the fibres of the nerves: trigeminal; Auricular magnum and minor occipital (sensitive branch of the cervical plexus) and the vagus nerve. The vagus nerve is responsible for the parasympathetic innervation of the lung, heart, stomach, and small intestine, as well as the pharynx and larynx muscles and it also sends information to important brain regions (e.g., locus coeruleus, orbitofrontal cortex, hippocampus and at amygdala) in the regulation of anxiety. In turn, the trigeminal nerve controls, mainly, the mastication muscles and the facial sensitivity while the cervical plexus nerve is responsible for neck muscles, diaphragm, and thorax.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, 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

  • University students
  • Unfamiliar with auriculotherapy,
  • No psychological disorders measured through Brief Symptom Inventory scale.

排除标准

  • Students having any neurological disease, cardiovascular disease, renal disease or any chronic disease, such as diabetes or hypertension.
  • Pregnants.
  • Under psychiatric medication.

结局指标

主要结局

Change on Spielberger's State-Trait-Anxiety Inventory (STAI)

时间窗: Change from baseline to after 8 and 24 hours.

Was developed by Spielberger and colleagues in 1970, validated for the Portuguese population, with the aim of analyzing anxiety symptoms. STAI is an instrument for measuring the state and trait of anxiety, consisting of two auto-answer questionnaires, each consisting of 20 items. The score ranges from 20 to 80 points on both scales, where 20 to 35 points means not anxious, 36 to 50 points is considered little anxious; 51 to 65 points means moderately anxious; and finally, 66 to 80 points the participant is considered very anxious.

Change on Salivary amylase (U/ml)

时间窗: Change from baseline to after 16 hours.

The method responds to both pancreatic and salivary amylase isoenzymes. Samples will be diluted prior to analysis and all measurements are going to be in compliance with the national legal requirements.

次要结局

  • Change on Visual analogic scale (VAS) for anxiety(Change from one week before baseline to after 8 and 24 hours.)
  • Change on quality of sleep(Change from one week before baseline to after 8 and 24 hours.)
  • Change on Blood Glucose levels(Change from baseline to after 30 minutes and 24 hours.)
  • Test performance(one week after examinations)
  • Adverse effects(up to one week after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreia Vieira

Principal Investigator

Universidade do Porto

研究点 (2)

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