Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students (AURITEST)

Fundació Tecnocampus Mataró-Maresme

Status: Completed

Conditions: Insomnia; Anxiety; Stress

Treatments: Other: Sham auricular stimulation (SAS); Other: Non-invasive auricular stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06442826

8/2023

Details and patient eligibility

About

In Spain, depression, anxiety, and stress are highly prevalent in the general population as well as in college students. In college students, Ramón Arbués et al. found a moderate prevalence of depression (18.4%), anxiety (23.6%) and stress (34.5%). It is essential to take responsibility for promoting health education, disease prevention, protection and care for young people.

Academic performance can be altered due to the stressful nature of exam situations, which can lead to increased anxiety and decrease expected performance, mainly due to effects such as decreased attention span, concentration and retention of information.

Modulation of vagal tone is a therapeutical strategy to heightened parasympathetic activity and withdrawal sympathetic activity. Auricular transcutaneous VNS (ATVNS) by which parasympathetic nerve system is modulated by means of the stimulation of the auricular branch of the vagus nerve that provides somatosensory innervation to the external ear.

It has been shown that there are different effective interventions to reduce the symptoms of stress, depression, anxiety and insomnia in university students, but they are based on psychological interventions or face-to-face and cognitive-behavioral therapeutic approach, so this study proposal incorporates noninvasive atrial stimulation as an alternative to traditional treatments, which apart from being cost-effective, is easy to apply, well tolerated and presumably can have beneficial effects in the short term.

In the present pilot study, authors propose to investigate the degree of depression, anxiety and stress on crucial dates of final exams of 1st year students of the Double Degree Physiotherapy - Physical Activity and Sport Sciences of the Health Department of the TecnoCampus.

Investigators will also evaluate the feasibility of a study to assess the efficacy of a non-pharmacological intervention, through a neuroreflex stimulation of vagal tone, with a non-invasive atrial stimulation protocol.

Full description

Personal pronouns have been removed

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years old
• Tecnocampus undergraduate students from Physical Therapy and Sports Science Double Degree of 1rst course.
• To sign the informed consent
• Understand Catalan or Spanish language
• With the intention to attend to the first call exams of the 2nd trimester.

Exclusion criteria

• Receiving pharmacological medication for anxiety or mental disorders
• Receiving psychological treatment
• Pregnancy or breastfeeding
• Participants with part-time enrolment
• With skin lesions in both auricula,
• Participating in another study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

True non-invasive auricular stimulation (TniAS)

Experimental group

Description:

Ear stimulation using true ear patches

Treatment:

Other: Non-invasive auricular stimulation

Sham auricular stimulation (SAS)

Placebo Comparator group

Description:

Ear stimulation using sham ear patches

Treatment:

Other: Sham auricular stimulation (SAS)

No-intervention group (NI)

No Intervention group

Description:

Participants in the No-Intervention group (NI) will not receive any active intervention as part of the trial.