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

NCT05042778 | Completed DMC

• 1 other identifier: ESSSMUporto
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Vagus nerve stimulation; auriculotherapy; students

Outcome Measures

Primary Outcomes (2)

• 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 from baseline to after 8 and 24 hours.

• 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.

  Change from baseline to after 16 hours.

Secondary Outcomes (5)

• 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

Study Arms (2)

Auriculotherapy

EXPERIMENTAL

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

Other: Auriculotherapy

No intervention

NO INTERVENTION

No auriculotherapy will be applied.

Interventions

Auriculotherapy OTHER

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.

Auriculotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Porto: lead
• Escola Superior Saúde Santa Maria: collaborator

Study Sites (1)

ICBAS

Porto, 4050-313 Porto, Portugal

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Auriculotherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jorge Machado, Ph.D

  Instituto de Ciências Biomédicas Abel Salazar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 13, 2021
• Study Start: September 1, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)