StressPhase 2NCT01420848
Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student
A Phase 2 study testing Auriculotherapy in people with Stress and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of true and placebo auriculotherapy. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Auriculotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Average and high score by the List of Stress Symptoms
- Voluntary participation in the study
- Availability of time for submission to the sessions
Who cannot join
- Pregnancy
- Medical license or vacation during the period
- Low score of stress
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, São Paulo, 01323-001
About this study
Official title: The Effectiveness of the Auriculotherapy on Reducing Stress and Anxiety in Nursing Student: Randomized Clinical Trial
Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of true and placebo auriculotherapy.
Read the detailed description
Although researches on stress have a strong focus on stress at work,it is very important the evaluation of the stress and its consequences in Nursing students. This allows to understand which stress factors experienced in a negative way could interfere on the adaptive success in school activities. Students can experience symptoms of the alarm phase of stress such as tachycardia, muscle tension, skin and cold extremities, and also the second phase of stress such as headache, sleepiness, irritability and difficulty concentrating. High levels of stress have a substantial effect on attention and can lead to errors, lack of concentration and fluctuations in the level of attention. The auriculotherapy may have an important role as a coping strategy for stress and anxiety. It is a fast, relatively simple, easily performed, safe and without major side effects.
- Being tested
- Auriculotherapy, Placebo Group
- Keywords
- stress disorders, anxiety disorders
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuriculotherapyOther
Also called Auricular acupuncture
Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.
Placebo GroupOther
Also called Sham Group
They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.
| Study group | Role | What they receive |
|---|---|---|
| Auriculotherapy Group | Active comparator | The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). Receives: Other: Auriculotherapy |
| Placebo Group | Placebo comparator | Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. Receives: Other: Placebo Group |
| Control Group | No intervention | Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students Stress Levels
The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.
Measured: 90 days
Secondary outcomes (1)
Students Anxiety Levels
The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
- Investigators
- Juliana M Prado, Principal investigator, University of Sao PauloLeonice FS Kurebayashi, Study director, University of Sao PauloMaria Julia P Silva, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420848
- Sponsor's protocol ID
- SISNEP CAAE 0107.0.360.000-11
- Status last verified
- Jun 2013
- First submitted
- 19 Aug 2011
- Last updated
- 15 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Giaponesi ANL, Leão ER. Auriculotherapy as an intervention to reduce stress reduction among the nursing team in intensive care. Nursing (São Paulo);12(139):575-579, dez. 2009. ilus.
do Prado JM, Kurebayashi LF, da Silva MJ. Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):727-35. doi: 10.1590/s0104-11692012000400013. English, Portuguese, Spanish.
PubMed 22990158
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Auriculotherapy on Reducing Stress and Anxiety in Nursing Student: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01420848
- Acronym / sponsor ID
- SISNEP CAAE 0107.0.360.000-11
- Keywords
- stress disorders, anxiety disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 15 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of true and placebo auriculotherapy.
Detailed description
Although researches on stress have a strong focus on stress at work,it is very important the evaluation of the stress and its consequences in Nursing students. This allows to understand which stress factors experienced in a negative way could interfere on the adaptive success in school activities. Students can experience symptoms of the alarm phase of stress such as tachycardia, muscle tension, skin and cold extremities, and also the second phase of stress such as headache, sleepiness, irritability and difficulty concentrating. High levels of stress have a substantial effect on attention and can lead to errors, lack of concentration and fluctuations in the level of attention. The auriculotherapy may have an important role as a coping strategy for stress and anxiety. It is a fast, relatively simple, easily performed, safe and without major side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auriculotherapy Group | Active comparator | Other: AuriculotherapyThe chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). |
| Placebo Group | Placebo comparator | Other: Placebo GroupAuriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. |
| Control Group | No intervention | –Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Average and high score by the List of Stress Symptoms
- Voluntary participation in the study
- Availability of time for submission to the sessions
Key exclusion criteria (3 listed)
- Pregnancy
- Medical license or vacation during the period
- Low score of stress
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 |
|---|---|---|
| AuriculotherapyAlso: Auricular acupunctureAuriculotherapy stimulates points to achieve better emotional balance, mental and physiological. | Other | Auriculotherapy Group |
| Placebo GroupAlso: Sham GroupThey were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points. | Other | Placebo Group |
Primary outcome
Students Stress Levels
Time frame: 90 days
The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.
1 secondary outcome
Students Anxiety Levels
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGiaponesi ANL, Leão ER. Auriculotherapy as an intervention to reduce stress reduction among the nursing team in intensive care. Nursing (São Paulo);12(139):575-579, dez. 2009. ilus.
- Derived from this study: PubMed 22990158do Prado JM, Kurebayashi LF, da Silva MJ. Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):727-35. doi: 10.1590/s0104-11692012000400013. English, Portuguese, Spanish.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Juliana M Prado principal investigator
University of Sao Paulo
Leonice FS Kurebayashi study director
University of Sao Paulo
Maria Julia P Silva study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auriculotherapy in people with Stress and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
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 15 Jul 2013. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Students Stress Levels (time frame: 90 days). 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 NCT01420848, which also lists 2 linked publications.
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 15 Jul 2013.