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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Auriculotherapy
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Vagus nerve stimulation, auriculotherapy, students

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ICBAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Auriculotherapy

No intervention

Arm Description

Indwelling fixed semipermanent needles embedded in a skin-colored adhesive tape will be used in active points around the vagus nerve stimulation area.

No auriculotherapy will be applied.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change on Visual analogic scale (VAS) for anxiety
Consists of a horizontal or vertical line, 100 mm long, which has marked the classification "totally calm and relaxed" at one end and, at the other, the classification "Worst fear imaginable". The respondent should mark the point that represents the degree of intensity of his anxiety. The distance between the beginning of the line, which corresponds to zero and the marked location, is then measured in centimeters, thus obtaining a numerical classification. The scale is reliable and correlated with STAI-Y1 (p <0.0001) for the level of anxiety and was used on our previous study
Change on quality of sleep
The participants will be asked about the quality of sleep during the night before as: 1-no change, 2-better or 3- worse than the quality of sleep during the previous week.
Change on Blood Glucose levels
Cortisol acts on two distinct fronts that results in increased amounts of glucose in the bloodstream. It stimulates gluconeogenesis in the liver, and the glucose produced is released into the bloodstream and stored as glycogen. In addition, by potentiating the effects of epinephrine, it elevates glycogenolysis in the liver, thus releasing a large amount of glucose into the bloodstream within minutes.
Test performance
After the exam, the test performance (pass or fail) will also be recorded.
Adverse effects
We will collect data related to auriculotherapy´ adverse effects (e.g, pain, presence of hematoma, vagal reaction, and infection), by replying the Adverse effect questionnaire after the procedure, as well as 1 week after completion of the experimental session.

Full Information

First Posted
August 25, 2021
Last Updated
October 31, 2022
Sponsor
Universidade do Porto
Collaborators
Escola Superior Saúde Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT05042778
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
Collaborators
Escola Superior Saúde Santa Maria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Vagus nerve stimulation, auriculotherapy, students

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auriculotherapy
Arm Type
Experimental
Arm Description
Indwelling fixed semipermanent needles embedded in a skin-colored adhesive tape will be used in active points around the vagus nerve stimulation area.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No auriculotherapy will be applied.
Intervention Type
Other
Intervention Name(s)
Auriculotherapy
Intervention Description
A licensed acupuncturist (holder of civil liability insurance) with more than nine years of experience with this technique will apply auriculotherapy. Indwelling fixed semipermanent needles embedded in a skin-coloured adhesive tape will be used at the actives auricular points around the vagus nerve area.
Primary Outcome Measure Information:
Title
Change on Spielberger's State-Trait-Anxiety Inventory (STAI)
Description
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.
Time Frame
Change from baseline to after 8 and 24 hours.
Title
Change on Salivary amylase (U/ml)
Description
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.
Time Frame
Change from baseline to after 16 hours.
Secondary Outcome Measure Information:
Title
Change on Visual analogic scale (VAS) for anxiety
Description
Consists of a horizontal or vertical line, 100 mm long, which has marked the classification "totally calm and relaxed" at one end and, at the other, the classification "Worst fear imaginable". The respondent should mark the point that represents the degree of intensity of his anxiety. The distance between the beginning of the line, which corresponds to zero and the marked location, is then measured in centimeters, thus obtaining a numerical classification. The scale is reliable and correlated with STAI-Y1 (p <0.0001) for the level of anxiety and was used on our previous study
Time Frame
Change from one week before baseline to after 8 and 24 hours.
Title
Change on quality of sleep
Description
The participants will be asked about the quality of sleep during the night before as: 1-no change, 2-better or 3- worse than the quality of sleep during the previous week.
Time Frame
Change from one week before baseline to after 8 and 24 hours.
Title
Change on Blood Glucose levels
Description
Cortisol acts on two distinct fronts that results in increased amounts of glucose in the bloodstream. It stimulates gluconeogenesis in the liver, and the glucose produced is released into the bloodstream and stored as glycogen. In addition, by potentiating the effects of epinephrine, it elevates glycogenolysis in the liver, thus releasing a large amount of glucose into the bloodstream within minutes.
Time Frame
Change from baseline to after 30 minutes and 24 hours.
Title
Test performance
Description
After the exam, the test performance (pass or fail) will also be recorded.
Time Frame
one week after examinations
Title
Adverse effects
Description
We will collect data related to auriculotherapy´ adverse effects (e.g, pain, presence of hematoma, vagal reaction, and infection), by replying the Adverse effect questionnaire after the procedure, as well as 1 week after completion of the experimental session.
Time Frame
up to one week after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Machado, Ph.D
Organizational Affiliation
Instituto de Ciências Biomédicas Abel Salazar
Official's Role
Study Director
Facility Information:
Facility Name
ICBAS
City
Porto
ZIP/Postal Code
4050-313 Porto
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results can be disseminated through workshops or seminars, or newsletters, to reach the largest number of people. Among educational institutions, a workshop can be held on the importance of implementing strategies to reduce situational anxiety. Communications could be whispered at scientific meetings and publications in journals to contribute about auriculotherapy effects, physiologic mechanisms and safety.
Citations:
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
Results Reference
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Is Auriculotherapy Responsible for Improvements on Anxiety Students' Prior and After Examinations?

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