Clinical trial NCT05042778: Is Auriculotherapy Responsible for Improvements on Anxiety Students' Prior and After Examinations?
Official title: Is Auriculotherapy Responsable for Improvements on Anxiety Students' Prior and After Examinations?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Vagus nerve stimulation
auriculotherapy
students
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Escola Superior Saúde Santa Maria
First posted: 2021-09-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change on Spielberger's State-Trait-Anxiety Inventory (STAI)
timeFrame: Change from baseline to after 8 and 24 hours.
measure: Change on Salivary amylase (U/ml)
timeFrame: Change from baseline to after 16 hours.
Secondary outcomes:
measure: Change on Visual analogic scale (VAS) for anxiety
timeFrame: Change from one week before baseline to after 8 and 24 hours.
measure: Change on quality of sleep
timeFrame: Change from one week before baseline to after 8 and 24 hours.
measure: Change on Blood Glucose levels
timeFrame: Change from baseline to after 30 minutes and 24 hours.
measure: Test performance
timeFrame: one week after examinations
measure: Adverse effects
timeFrame: up to one week after baseline
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: ICBAS
Study officials:
affiliation: Instituto de Ciências Biomédicas Abel Salazar
name: Jorge Machado, Ph.D
role: STUDY_DIRECTOR
References:
citation: Vieira, A., Hinzmann, M., Silva, K., Santos, M., & Machado, J. (2018). Clinical effect of auricular acupuncture in anxiety levels of students prior to the exams: A randomized controlled trial. European Journal of Integrative Medicine, 20, 188-192. doi:https://doi.org/10.1016/j.eujim.2018.05.012