Stress
Conditions
Keywords
Stress
Brief summary
Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.
Detailed description
Seventy five participants with average and high scores on the Stress Symptoms List (LSS) were divided in 3 groups (control, needles and seeds). They were evaluated at the baseline, fourth and eighth sessions and 15-day follow-up and received 8 sessions through Shenmen, Kidney and Brainstem points.
Interventions
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.
We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
23 Years to 61 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 |
|---|---|---|
| Stress Levels After 4 Sessions (2nd Evaluation) | after 30 days | Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress Levels(3rd and 4th Evaluation) | after 60 and 75 days | Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points. |
Countries
Brazil
Participant flow
Recruitment details
Recruitment was conducted between January and July 2010 at University Hospital. Study participants were professionals from different sectors of the hospital after the invitation and 109 people answered the first questionnaire of stress (LSS). Obeying the exclusion criteria, 75 subjects were enrolled and randomized into three groups.
Pre-assignment details
Withdrawal:employees went on vacation(7),sick leave(2), lost treatment for loss of time, forgetfulness,difficulty of rescheduling (12), withdrawal due to side effects, in this case, nightmares (1); low score (1), not belonging to the nursing staff (3), failure to attend the first session (7) not having completed the questionnaires (1)
Participants by arm
| Arm | Count |
|---|---|
| Auriculotherapy by Seeds Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times. | 26 |
| Auriculotherapy by Needles Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. | 27 |
| Control Group untreated group | 22 |
| Total | 75 |
Baseline characteristics
| Characteristic | Auriculotherapy by Seeds | Auriculotherapy by Needles | Control 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 | 26 Participants | 27 Participants | 22 Participants | 75 Participants |
| Age Continuous | 45.57 years STANDARD_DEVIATION 6.4 | 41.37 years STANDARD_DEVIATION 8.23 | 39.25 years STANDARD_DEVIATION 13.17 | 42.06 years STANDARD_DEVIATION 9.27 |
| Region of Enrollment Brazil | 26 participants | 27 participants | 22 participants | 75 participants |
| score stress | 63.27 scores on a scale STANDARD_DEVIATION 26.05 | 66.82 scores on a scale STANDARD_DEVIATION 18.56 | 54.36 scores on a scale STANDARD_DEVIATION 15.9 | 61.48 scores on a scale STANDARD_DEVIATION 20.17 |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 21 Participants | 71 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants | 4 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 / 26 | 3 / 27 | 0 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 | 0 / 22 |
Outcome results
Primary
Stress Levels After 4 Sessions (2nd Evaluation)
Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points.
Time frame: after 30 days
Population: Of the 109 subjects, four were eliminated for having a low level of stress and 3 for not belonging to nursing staff. Of the 105, 7 didn't appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one did not complete the questionnaire, seven went on vacation or sick leave (2).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Stress Levels After 4 Sessions (2nd Evaluation) | 49.68 units on a scale | Standard Deviation 17.99 |
| Needle Group | Stress Levels After 4 Sessions (2nd Evaluation) | 54.69 units on a scale | Standard Deviation 27.1 |
| Seeds Group | Stress Levels After 4 Sessions (2nd Evaluation) | 54.00 units on a scale | Standard Deviation 25.04 |
Comparison: Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.p-value: 0.35295% CI: [-76, 23]ANOVA
Secondary
Stress Levels(3rd and 4th Evaluation)
Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points.
Time frame: after 60 and 75 days
Population: 75 participants were assessed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Stress Levels(3rd and 4th Evaluation) | follow-up | 72.62 units on a scale | Standard Deviation 31.51 |
| Control Group | Stress Levels(3rd and 4th Evaluation) | 3rd evaluation | 67.87 units on a scale | Standard Deviation 25.73 |
| Needle Group | Stress Levels(3rd and 4th Evaluation) | 3rd evaluation | 59.84 units on a scale | Standard Deviation 23.04 |
| Needle Group | Stress Levels(3rd and 4th Evaluation) | follow-up | 55.54 units on a scale | Standard Deviation 25.26 |
| Seeds Group | Stress Levels(3rd and 4th Evaluation) | 3rd evaluation | 67.10 units on a scale | Standard Deviation 23.77 |
| Seeds Group | Stress Levels(3rd and 4th Evaluation) | follow-up | 69.20 units on a scale | Standard Deviation 30.03 |
Comparison: It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.p-value: 0.02395% CI: [-67, 37]ANOVA