Anxiety, Stress
Conditions
Keywords
stress disorders, anxiety disorders
Brief 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.
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.
Interventions
OTHERAuriculotherapy
Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.
OTHERPlacebo 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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Average and high score by the List of Stress Symptoms * Voluntary participation in the study * Availability of time for submission to the sessions
Exclusion criteria
* Pregnancy * Medical license or vacation during the period * Low score of stress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Students Stress Levels | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Students Anxiety Levels | 90 days | 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. |
Countries
Brazil
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Control Group Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group | 25 |
| Placebo Group Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety. | 22 |
| Total | 71 |
Baseline characteristics
| Characteristic | Control Group | Placebo Group | Auriculotherapy Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 22 Participants | 24 Participants | 71 Participants |
| Age Continuous | 28.68 years STANDARD_DEVIATION 6.57 | 30.91 years STANDARD_DEVIATION 8.34 | 27.21 years STANDARD_DEVIATION 5.97 | 28.93 years STANDARD_DEVIATION 6.96 |
| Region of Enrollment Brazil | 25 participants | 22 participants | 24 participants | 71 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 20 Participants | 64 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 24 | 0 / 25 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 | 0 / 22 |
Outcome results
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.
Time frame: 90 days
Population: It was analysed only the subjects that ended the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auriculotherapy Group | Students Stress Levels | 75.62 units on a scale | Standard Deviation 26.5 |
| Control Group | Students Stress Levels | 67.72 units on a scale | Standard Deviation 22.38 |
| Placebo Group | Students Stress Levels | 72.45 units on a scale | Standard Deviation 25.65 |
Comparison: It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.p-value: 0.006ANOVA
Comparison: It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days).p-value: 0.023ANOVA
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.
Time frame: 90 days
Population: It was analysed only the number of participants that ended the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auriculotherapy Group | Students Anxiety Levels | Trait Anxiety | 52.58 units on a scale | Standard Deviation 9.29 |
| Auriculotherapy Group | Students Anxiety Levels | State Anxiety | 54.04 units on a scale | Standard Deviation 10.74 |
| Control Group | Students Anxiety Levels | Trait Anxiety | 49.48 units on a scale | Standard Deviation 7.57 |
| Control Group | Students Anxiety Levels | State Anxiety | 50.16 units on a scale | Standard Deviation 10.79 |
| Placebo Group | Students Anxiety Levels | Trait Anxiety | 51.18 units on a scale | Standard Deviation 10.32 |
| Placebo Group | Students Anxiety Levels | State Anxiety | 51.59 units on a scale | Standard Deviation 11.7 |
Comparison: It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)p-value: 0.012ANOVA
Comparison: 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).p-value: 0.005ANOVA