AnxietyAURITESTNCT06442826
Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students
A study testing Non-invasive auricular stimulation in people with Anxiety and Stress, run by Fundació Tecnocampus Mataró-Maresme at 1 site in Spain.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Non-invasive auricular stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students: A Pilot 3-arm Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
Personal pronouns have been removed
- Being tested
- Non-invasive auricular stimulation, Sham auricular stimulation (SAS)
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive auricular stimulationOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| True non-invasive auricular stimulation (TniAS) | Experimental | Ear stimulation using true ear patches Receives: Other: Non-invasive auricular stimulation |
| Sham auricular stimulation (SAS) | Placebo comparator | Ear stimulation using sham ear patches Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment strategy effectiveness
- 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.
Measured: 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
Measured: Week 2
Secondary outcomes (10)
Exclusion rate
The exclusion rate will be analyzed based on the percentage of participants interested in the study who do not fulfill the inclusion criteria. Additionally, reasons for exclusion will be documented.
Measured: Week 0
Dropout rate
We will meticulously record and analyze the percentage of participants who discontinue or withdraw from the study, which means they do not attend the final assessment session. Detailed information about the reasons for dropout will be collected to gain valuable insights into participant retention and engagement throughout the study
Measured: Week 2
Compliance to the intervention protocol
We will assess the percentage of participants who adhere to the treatment protocol. Participants will be considered adherent if at least two out of the four auricular stimulation patches remain in place at the final assessment visit. Adherence will be evaluated based on self-reported information provided by participants during the last assessment interview.
Measured: Week 2
Data collection feasibility
We will evaluate the feasibility of our data collection methods by gauging participants' perceptions of the ease of administration, comprehensibility, and time required for data collection. This assessment will employ a 5-point Likert scale and will be complemented by qualitative feedback. Additionally, outcome assessors will record any difficulties encountered during the data collection process.
Measured: Week 2
Participant blinding success:
To determine the success of participant blinding, we will inquire during the final assessment session whether participants believe they received an active treatment. They will be provided with response options including "Yes," "No," or "I don't know.
Measured: Week 2
Outcome assessor blinding success
he success of outcome assessor blinding will be assessed at the end of the final evaluation of each participant. Assessors will have to choose between 3 possible answers; "the participant was in the intervention group", "the participant was in the sham group", or "I don't know".
Measured: Week 2
Anxiety
We will employ the DASS anxiety subscale to measure participants' anxiety levels. This subscale comprises questions that delve into anxiety-related feelings and experiences, providing a quantitative measure of anxiety symptomatology. Higher scores on this subscale indicate greater levels of anxiety.
Measured: Week 2
Stress
The DASS instrument includes a stress subscale that helps us assess participants' stress levels. Participants will respond to items that reflect stress-related experiences, allowing us to quantify their perceived stress. Higher scores on this subscale indicate elevated stress levels.
Measured: Week 2
Depression
The DASS also contains a depression subscale that enables us to assess depressive symptoms. Participants will provide responses related to their mood and emotional well-being, allowing us to gauge the extent of their depressive symptomatology. Higher scores on this subscale indicate a greater level of depressive symptoms.
Measured: Week 2
Insomnia
The ISI consists of seven items that assess the severity of sleep-onset and sleep-maintenance difficulties, satisfaction with current sleep patterns, interference with daily functioning, noticeability of impairments attributed to sleep problems, and the level of distress caused by the sleep difficulties. Higher scores indicates greater insomnia severity.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 May 2024
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Tecnocampus Mataró-Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442826
- Sponsor's protocol ID
- 8/2023
- Acronym
- AURITEST
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students: A Pilot 3-arm Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06442826
- Acronym / sponsor ID
- AURITEST / 8/2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundació Tecnocampus Mataró-MaresmeUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True non-invasive auricular stimulation (TniAS) | Experimental | Other: Non-invasive auricular stimulationEar stimulation using true ear patches |
| Sham auricular stimulation (SAS) | Placebo comparator | Other: Sham auricular stimulation (SAS)Ear stimulation using sham ear patches |
| No-intervention group (NI) | No intervention | –Participants in the No-Intervention group (NI) will not receive any active intervention as part of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive auricular stimulationSingle 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 | True non-invasive auricular stimulation (TniAS) |
| 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. | Other | Sham auricular stimulation (SAS) |
Primary outcome
Recruitment strategy effectiveness
Time frame: Week 0
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.
Safety and Tolerability
Time frame: Week 2
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
10 secondary outcomes
Exclusion rate
Time frame: Week 0
Dropout rate
Time frame: Week 2
Compliance to the intervention protocol
Time frame: Week 2
Data collection feasibility
Time frame: Week 2
Participant blinding success:
Time frame: Week 2
Outcome assessor blinding success
Time frame: Week 2
Anxiety
Time frame: Week 2
Stress
Time frame: Week 2
Depression
Time frame: Week 2
Insomnia
Time frame: Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive auricular stimulation in people with Anxiety and Stress, run by Fundació Tecnocampus Mataró-Maresme at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment strategy effectiveness (time frame: Week 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.