NCT06442826

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

Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students: A Pilot 3-arm Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fundació Tecnocampus Mataró-Maresme · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Anxiety
• Stress
• Insomnia

Interventions

Type	Name	Description
OTHER	Non-invasive auricular stimulation	Single session TniAS stimulation will be achieved by applying four stimulation patches. These patches consist of stainless steel spheres with a diameter of 1.2 mm, covered with adhesive circular paper measuring 8 mm in diameter. Point 1. Located in the Triangular Fossa, upper and central level at the vertex of the Fossa, at junction between the upper root and the lower root of the Antihelix. Point 2. Located in the inner part of the Cymba (upper) conchae, in the angle formed by the lower root of the antihelix and the ascending branch of the Helix. Point 3. Located in the middle depression of the Cavum (lower) conchae. Poinit 4. It is located at the inner superior quadrant of Lobe, below the external curve of the Intertragus notch, in a depression 3-4 mm from the insertion of the lobe to the face.
OTHER	Sham auricular stimulation (SAS)	Sham intervention will be conducted following the exact same procedure as the TniAS group, with the only difference being the use of sham stimulation patches. These sham patches will consist of the same patches utilized in the TniAS group, except for the absence of the stainless steel spheres. During the application of these sham patches, the investigator will adhere to the identical process as in the TniAS group, with the exception that no palpation will be performed to locate the exact points, and only minimal pressure required for patch adherence will be applied to minimize any substantial stimulation. Participants in the SAS group will also be explicitly instructed not to stimulate the points until the removal of the patches. The removal of the sham stimulation patches will follow the precise protocol applied in the TniAS group, ensuring consistency in the study procedures across both groups.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2024-06-04
• Last updated: 2024-11-22

Locations

1 site across 1 country: Spain