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

NCT06442826 | Completed

• 1 other identifier: 8/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Stress; Insomnia

Outcome Measures

Primary Outcomes (2)

• Recruitment strategy effectiveness

  o evaluate the effectiveness of our recruitment strategy, we will analyze several key metrics, including the number of eligible participants, the number who expressed interest by completing the initial form, the participants who proceeded to the initial interview, and finally, the number of students who enrolled in the study. Additionally, we will carefully examine the reasons provided by students who declined to participate, allowing us to refine our recruitment approach.

  Week 0

• Safety and Tolerability

  Any side effects that may arise during the study will be meticulously monitored, and their frequency and severity will be assessed based on patients' self-reports. These side effects will be categorized as either minor, relevant, or important according to the patients' descriptions and assessments. Additionally, we will maintain a record of the number of participants who chose to remove at least one of the patches due to the side effects they experienced

  Week 2

Secondary Outcomes (10)

• Exclusion rate

  Week 0

• Dropout rate

  Week 2

• Compliance to the intervention protocol

  Week 2

• Data collection feasibility

  Week 2

• Participant blinding success:

  Week 2

Study Arms (3)

True non-invasive auricular stimulation (TniAS)

EXPERIMENTAL

Ear stimulation using true ear patches

Other: Non-invasive auricular stimulation

Sham auricular stimulation (SAS)

PLACEBO COMPARATOR

Ear stimulation using sham ear patches

Other: Sham auricular stimulation (SAS)

No-intervention group (NI)

NO INTERVENTION

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

Interventions

Non-invasive auricular stimulation OTHER

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.

True non-invasive auricular stimulation (TniAS)

Sham auricular stimulation (SAS) OTHER

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.

Sham auricular stimulation (SAS)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Tecnocampus Mataró-Maresme: lead

Study Sites (1)

Tecnocampus

Mataró, Barcelona, 08302, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 4, 2024
• Study Start: May 1, 2024
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)