Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442826
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-30
Brief Title:
Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students
Sponsor:
Fundació Tecnocampus Mataró-Maresme
Organization:
Fundació Tecnocampus Mataró-Maresme
Study Overview
Official Title:
Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students A Pilot 3-arm Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AURITEST
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 184 anxiety 236 and stress 345 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None