Clinical trial NCT06442826: Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students
Official title: Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students: A Pilot 3-arm Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Insomnia
Lead sponsor: Fundació Tecnocampus Mataró-Maresme
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Personal pronouns have been removed

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment strategy effectiveness
timeFrame: Week 0
measure: Safety and Tolerability
timeFrame: Week 2
Secondary outcomes:
measure: Exclusion rate
timeFrame: Week 0
measure: Dropout rate
timeFrame: Week 2
measure: Compliance to the intervention protocol
timeFrame: Week 2
measure: Data collection feasibility
timeFrame: Week 2
measure: Participant blinding success:
timeFrame: Week 2
measure: Outcome assessor blinding success
timeFrame: Week 2
measure: Anxiety
timeFrame: Week 2
measure: Stress
timeFrame: Week 2
measure: Depression
timeFrame: Week 2
measure: Insomnia
timeFrame: Week 2
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Tecnocampus
state: Barcelona
Study officials:
References: