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Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group without treatment | No Intervention | Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group | |
| Auriculotherapy by needles | Experimental | The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. |
|
| Auriculotherapy by seeds | Experimental | The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| auriculotherapy by needles | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after 60 and 75 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Julia P Silva | Escola de Enfermagem da Universidade de São Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário da Universidade de São Paulo | São Paulo | São Paulo | 05508-000 | Brazil |
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)
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Auriculotherapy by Needles | Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. |
| FG002 | Control Group | untreated group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Auriculotherapy by Needles |
| 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 | 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. | 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). | Posted | Jul 2011 | Mean | Standard Deviation | units on a scale | after 30 days |
|
one month
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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 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abnormal dreams | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | nightmares |
Study limitations: small sample size
Bias procedure with auricular seeds: the non-participation of the subject of research in self-massage of the points
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonice Fumiko Sato Kurebayashi | University of São Paulo | 55-11-91126023 | fumie_ibez@yahoo.com.br |
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| ID | Term |
|---|---|
| D020831 | Acupuncture, Ear |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
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|
| auriculotherapy by seeds | Other | 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. |
|
|
Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. |
| BG002 | Control Group | untreated group |
| 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 |
|
| score stress | The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 60 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 above 120, very high level. Participants below 29 points were excluded. | Mean | Standard Deviation | scores on a scale |
|
Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation). |
| OG002 | Seeds Group | They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation). |
|
|
|
| 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. | 75 participants were assessed | Posted | Aug 2010 | Mean | Standard Deviation | units on a scale | after 60 and 75 days |
|
|
|
|
| 0 |
| 26 |
| 1 |
| 26 |
| EG001 | Auriculotherapy by Needles | Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. | 0 | 27 | 3 | 27 |
| EG002 | Control Group | untreated group | 0 | 22 | 0 | 22 |
| allergy | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | itching and redness in the auricular points |
|
| increase apettite | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | anxiety for food |
|
| anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | complaints of anxiety and unrest |
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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.
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| Superiority or Other |