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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo Group | Placebo Comparator | Auriculotherapy 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auriculotherapy | Other | Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliana M Prado | University of Sao Paulo | Principal Investigator |
| Leonice FS Kurebayashi | University of Sao Paulo | Study Director |
| Maria Julia P Silva | University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Real e Benemérita Associação Portuguesa de Beneficência | São Paulo | São Paulo | 01323-001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 22990158 | Derived | 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. |
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No sample size calculation was done for this study because the number of the population was small and it was decided to invite all students to attend nursing school test.
The recruitment of students was conducted between January and July 2011 at the Nursing School of Portuguese Beneficence Hospital. Eighty five people were invited and seventy one subjects were enrolled and randomized into 3 groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Auriculotherapy Group | 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). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological. |
| FG001 | Control Group | Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group |
| FG002 | Placebo Group | Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Auriculotherapy Group | 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). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | It was analysed only the subjects that ended the study. | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
3 months
Tenderness and pain at the auricular point after the treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auriculotherapy Group | 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). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Pain | Non-systematic Assessment | Pain and sensibility at the point after the treatment |
The limitation of the trial was the reduced number of the sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonice Fumiko Sato Kurebayashi | University of São Paulo | (5511 991126023) | fumie_ibez@yahoo.com.br |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D040921 | Stress Disorders, Traumatic |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D055097 | Auriculotherapy |
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
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| Placebo Group | Other | They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points. |
|
|
| 90 days |
| BG001 | Control Group | Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group |
| BG002 | Placebo Group | Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group |
| OG002 | Placebo Group | Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. |
|
|
|
| Secondary | 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. | It was analysed only the number of participants that ended the study. | Posted | Mean | Standard Deviation | units on a scale | 90 days |
|
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Control Group | Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group | 0 | 25 | 0 | 25 |
| EG002 | Placebo Group | Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. | 0 | 22 | 0 | 22 |
|
The copyright of the search results are the exclusive property of the Journal of School Nursing, University of Saint Paul, barring any reproduction, in whole or in part in any form or means of printed or electronic, without the prior and necessary authorization is requested.
|
It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days). Hypothesis: there is at least one difference among the groups (State Anxiety). |
| ANOVA |
| 0.005 |
After ANOVA, the Post Hoc Test was done and the statistical significance was p<0.05. |
| 95 |
| No |
| Superiority or Other |