AnxietyNCT05042778
Is Auriculotherapy Responsible for Improvements on Anxiety Students' Prior and After Examinations?
A study testing Auriculotherapy in people with Anxiety, run by Universidade do Porto at 1 site in Portugal.
Trial summary
As the investigators have shown before, there was a tendency for a reduction of anxiety levels on university students after 30 minutes, with auriculotherapy treatment before examinations have started. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Auriculotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2021to 3 Dec 2021
- 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
- University students
- Unfamiliar with auriculotherapy,
- No psychological disorders measured through Brief Symptom Inventory scale.
Who cannot join
- Students having any neurological disease, cardiovascular disease, renal disease or any chronic disease, such as diabetes or hypertension.
- Pregnants.
- Under psychiatric medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Auriculotherapy Responsable for Improvements on Anxiety Students' Prior and After Examinations?
As the investigators have shown before, there was a tendency for a reduction of anxiety levels on university students after 30 minutes, with auriculotherapy treatment before examinations have started. However, the effect was effective and clinically significant after 48 hours comparing auriculotherapy with placebo and no treatment. In this sense, the investigators intend to perform a new study with a large sample and introduce a new hypothesis. So, this study aims to detect the clinical effect of two auriculotherapy techniques on the anxiety levels of university students.
Read the detailed description
To treat anxiety, conventional medicine relies on medicines such as benzodiazepines, antidepressants, barbiturates, and antihistamines. However, several authors have reported western medicine cannot resolve all anxiety diseases and the risk of side effects, resistance to pharmacological treatments affects approximately one in three patients with anxiety disorders.
Alternatively, auriculotherapy is a technique similar to reflexology. It is speculated the technique might work in anxiety because groups of pluripotent cells contain information from the whole organism creating regional organization centres representing different parts of the body, through the recruitment of more cortex cells dedicated to specific body areas. Thus reflex points in the ear can incite body responses by the stimulation of reticular formation and the sympathetic and parasympathetic nervous systems. The information that comes from the thermal, Algic and proprioceptive stimuli are transmitted from the auricular pavilion by the fibres of the nerves: trigeminal; Auricular magnum and minor occipital (sensitive branch of the cervical plexus) and the vagus nerve. The vagus nerve is responsible for the parasympathetic innervation of the lung, heart, stomach, and small intestine, as well as the pharynx and larynx muscles and it also sends information to important brain regions (e.g., locus coeruleus, orbitofrontal cortex, hippocampus and at amygdala) in the regulation of anxiety. In turn, the trigeminal nerve controls, mainly, the mastication muscles and the facial sensitivity while the cervical plexus nerve is responsible for neck muscles, diaphragm, and thorax.
- Conditions
- Anxiety
- Being tested
- Auriculotherapy
- Keywords
- Anxiety, Vagus nerve stimulation, auriculotherapy, students
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriculotherapyOther
A licensed acupuncturist (holder of civil liability insurance) with more than nine years of experience with this technique will apply auriculotherapy. Indwelling fixed semipermanent needles embedded in a skin-coloured adhesive tape will be used at the actives auricular points around the vagus nerve area.
| Study group | Role | What they receive |
|---|---|---|
| Auriculotherapy | Experimental | Indwelling fixed semipermanent needles embedded in a skin-colored adhesive tape will be used in active points around the vagus nerve stimulation area. Receives: Other: Auriculotherapy |
| No intervention | No intervention | No auriculotherapy will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Spielberger's State-Trait-Anxiety Inventory (STAI)
Was developed by Spielberger and colleagues in 1970, validated for the Portuguese population, with the aim of analyzing anxiety symptoms. STAI is an instrument for measuring the state and trait of anxiety, consisting of two auto-answer questionnaires, each consisting of 20 items. The score ranges from 20 to 80 points on both scales, where 20 to 35 points means not anxious, 36 to 50 points is considered little anxious; 51 to 65 points means moderately anxious; and finally, 66 to 80 points the participant is considered very anxious.
Measured: Change from baseline to after 8 and 24 hours.
Change on Salivary amylase (U/ml)
The method responds to both pancreatic and salivary amylase isoenzymes. Samples will be diluted prior to analysis and all measurements are going to be in compliance with the national legal requirements.
Measured: Change from baseline to after 16 hours.
Secondary outcomes (5)
Change on Visual analogic scale (VAS) for anxiety
Consists of a horizontal or vertical line, 100 mm long, which has marked the classification "totally calm and relaxed" at one end and, at the other, the classification "Worst fear imaginable". The respondent should mark the point that represents the degree of intensity of his anxiety. The distance between the beginning of the line, which corresponds to zero and the marked location, is then measured in centimeters, thus obtaining a numerical classification. The scale is reliable and correlated with STAI-Y1 (p <0.0001) for the level of anxiety and was used on our previous study
Measured: Change from one week before baseline to after 8 and 24 hours.
Change on quality of sleep
The participants will be asked about the quality of sleep during the night before as: 1-no change, 2-better or 3- worse than the quality of sleep during the previous week.
Measured: Change from one week before baseline to after 8 and 24 hours.
Change on Blood Glucose levels
Cortisol acts on two distinct fronts that results in increased amounts of glucose in the bloodstream. It stimulates gluconeogenesis in the liver, and the glucose produced is released into the bloodstream and stored as glycogen. In addition, by potentiating the effects of epinephrine, it elevates glycogenolysis in the liver, thus releasing a large amount of glucose into the bloodstream within minutes.
Measured: Change from baseline to after 30 minutes and 24 hours.
Test performance
After the exam, the test performance (pass or fail) will also be recorded.
Measured: one week after examinations
Adverse effects
We will collect data related to auriculotherapy´ adverse effects (e.g, pain, presence of hematoma, vagal reaction, and infection), by replying the Adverse effect questionnaire after the procedure, as well as 1 week after completion of the experimental session.
Measured: up to one week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Escola Superior Saúde Santa Maria
- Responsible party
- Principal investigator, Andreia Vieira, Universidade do Porto
- Investigators
- Jorge Machado, Ph.D, Study director, Instituto de Ciências Biomédicas Abel Salazar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042778
- Sponsor's protocol ID
- ESSSMUporto
- Status last verified
- Oct 2022
- First submitted
- 25 Aug 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results can be disseminated through workshops or seminars, or newsletters, to reach the largest number of people. Among educational institutions, a workshop can be held on the importance of implementing strategies to reduce situational anxiety. Communications could be whispered at scientific meetings and publications in journals to contribute about auriculotherapy effects, physiologic mechanisms and safety.
Publications
Vieira, A., Hinzmann, M., Silva, K., Santos, M., & Machado, J. (2018). Clinical effect of auricular acupuncture in anxiety levels of students prior to the exams: A randomized controlled trial. European Journal of Integrative Medicine, 20, 188-192. doi:https://doi.org/10.1016/j.eujim.2018.05.012
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Auriculotherapy Responsable for Improvements on Anxiety Students' Prior and After Examinations?
- ClinicalTrials.gov ID
- NCT05042778
- Acronym / sponsor ID
- ESSSMUporto
- Conditions
- Anxiety
- Keywords
- Anxiety, Vagus nerve stimulation, auriculotherapy, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Escola Superior Saúde Santa Maria
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 13 Sep 2021 (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.
As the investigators have shown before, there was a tendency for a reduction of anxiety levels on university students after 30 minutes, with auriculotherapy treatment before examinations have started. However, the effect was effective and clinically significant after 48 hours comparing auriculotherapy with placebo and no treatment. In this sense, the investigators intend to perform a new study with a large sample and introduce a new hypothesis. So, this study aims to detect the clinical effect of two auriculotherapy techniques on the anxiety levels of university students.
Detailed description
To treat anxiety, conventional medicine relies on medicines such as benzodiazepines, antidepressants, barbiturates, and antihistamines. However, several authors have reported western medicine cannot resolve all anxiety diseases and the risk of side effects, resistance to pharmacological treatments affects approximately one in three patients with anxiety disorders.
Alternatively, auriculotherapy is a technique similar to reflexology. It is speculated the technique might work in anxiety because groups of pluripotent cells contain information from the whole organism creating regional organization centres representing different parts of the body, through the recruitment of more cortex cells dedicated to specific body areas. Thus reflex points in the ear can incite body responses by the stimulation of reticular formation and the sympathetic and parasympathetic nervous systems. The information that comes from the thermal, Algic and proprioceptive stimuli are transmitted from the auricular pavilion by the fibres of the nerves: trigeminal; Auricular magnum and minor occipital (sensitive branch of the cervical plexus) and the vagus nerve. The vagus nerve is responsible for the parasympathetic innervation of the lung, heart, stomach, and small intestine, as well as the pharynx and larynx muscles and it also sends information to important brain regions (e.g., locus coeruleus, orbitofrontal cortex, hippocampus and at amygdala) in the regulation of anxiety. In turn, the trigeminal nerve controls, mainly, the mastication muscles and the facial sensitivity while the cervical plexus nerve is responsible for neck muscles, diaphragm, and thorax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auriculotherapy | Experimental | Other: AuriculotherapyIndwelling fixed semipermanent needles embedded in a skin-colored adhesive tape will be used in active points around the vagus nerve stimulation area. |
| No intervention | No intervention | –No auriculotherapy will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- University students
- Unfamiliar with auriculotherapy,
- No psychological disorders measured through Brief Symptom Inventory scale.
Key exclusion criteria (3 listed)
- Students having any neurological disease, cardiovascular disease, renal disease or any chronic disease, such as diabetes or hypertension.
- Pregnants.
- Under psychiatric medication.
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 |
|---|---|---|
| AuriculotherapyA licensed acupuncturist (holder of civil liability insurance) with more than nine years of experience with this technique will apply auriculotherapy. Indwelling fixed semipermanent needles embedded in a skin-coloured adhesive tape will be used at the actives auricular points around the vagus nerve area. | Other | Auriculotherapy |
Primary outcome
Change on Spielberger's State-Trait-Anxiety Inventory (STAI)
Time frame: Change from baseline to after 8 and 24 hours.
Was developed by Spielberger and colleagues in 1970, validated for the Portuguese population, with the aim of analyzing anxiety symptoms. STAI is an instrument for measuring the state and trait of anxiety, consisting of two auto-answer questionnaires, each consisting of 20 items. The score ranges from 20 to 80 points on both scales, where 20 to 35 points means not anxious, 36 to 50 points is considered little anxious; 51 to 65 points means moderately anxious; and finally, 66 to 80 points the participant is considered very anxious.
Change on Salivary amylase (U/ml)
Time frame: Change from baseline to after 16 hours.
The method responds to both pancreatic and salivary amylase isoenzymes. Samples will be diluted prior to analysis and all measurements are going to be in compliance with the national legal requirements.
5 secondary outcomes
Change on Visual analogic scale (VAS) for anxiety
Time frame: Change from one week before baseline to after 8 and 24 hours.
Change on quality of sleep
Time frame: Change from one week before baseline to after 8 and 24 hours.
Change on Blood Glucose levels
Time frame: Change from baseline to after 30 minutes and 24 hours.
Test performance
Time frame: one week after examinations
Adverse effects
Time frame: up to one week after baseline
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 3 Nov 2022.
- BackgroundVieira, A., Hinzmann, M., Silva, K., Santos, M., & Machado, J. (2018). Clinical effect of auricular acupuncture in anxiety levels of students prior to the exams: A randomized controlled trial. European Journal of Integrative Medicine, 20, 188-192. doi:https://doi.org/10.1016/j.eujim.2018.05.012
- Individual participant dataSharing planned: No. Results can be disseminated through workshops or seminars, or newsletters, to reach the largest number of people. Among educational institutions, a workshop can be held on the importance of implementing strategies to reduce situational anxiety. Communications could be whispered at scientific meetings and publications in journals to contribute about auriculotherapy effects, physiologic mechanisms and safety.
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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.
Jorge Machado, Ph.D study director
Instituto de Ciências Biomédicas Abel Salazar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auriculotherapy in people with Anxiety, run by Universidade do Porto at 1 site in Portugal.
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 3 inclusion and 3 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 3 Nov 2022. 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 Portugal. 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. 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?
Change on Spielberger's State-Trait-Anxiety Inventory (STAI) (time frame: Change from baseline to after 8 and 24 hours.). 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?
On the ClinicalTrials.gov record for NCT05042778, which also lists 1 linked publication.
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 3 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.