Application of Auriculotherapy on Nursing Professional Stress Levels
Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01141374
Collaborator
(none)
75
1
3
5
15.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels
Study Start Date
:
Jan 1, 2010
Actual Primary Completion Date
:
Apr 1, 2010
Actual Study Completion Date
:
Jun 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: control group without treatment Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group |
|
| Experimental: Auriculotherapy by needles 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. |
Other: auriculotherapy by needles
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.
Other Names:
|
| Experimental: Auriculotherapy by seeds The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. |
Other: auriculotherapy by seeds
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
23 Years
to 61 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitário da Universidade de São Paulo | São Paulo | Brazil | 05508-000 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Study Director: Maria Julia P Silva, Escola de Enfermagem da Universidade de São Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Leonice Fumiko Sato Kurebayashi,
Leonice Fumiko Sato Kurebayashi,
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01141374
Other Study ID Numbers:
- SISNEP
First Posted:
Jun 10, 2010
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Leonice Fumiko Sato Kurebayashi,
Leonice Fumiko Sato Kurebayashi,
University of Sao Paulo
Additional relevant MeSH terms:
Study Results
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 Detail | 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) |
| Arm/Group Title | Auriculotherapy by Seeds | Auriculotherapy by Needles | Control Group |
|---|---|---|---|
| Arm/Group Description | 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. | Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. | untreated group |
| Period Title: Overall Study | |||
| STARTED | 26 | 27 | 22 |
| COMPLETED | 26 | 27 | 22 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Auriculotherapy by Seeds | Auriculotherapy by Needles | Control Group | Total |
|---|---|---|---|---|
| Arm/Group Description | 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. | Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. | untreated group | Total of all reporting groups |
| Overall Participants | 26 | 27 | 22 | 75 |
| Age (Count of Participants) | ||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
26
100%
|
27
100%
|
22
100%
|
75
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
45.57
(6.40)
|
41.37
(8.23)
|
39.25
(13.17)
|
42.06
(9.27)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
25
96.2%
|
25
92.6%
|
21
95.5%
|
71
94.7%
|
| Male |
1
3.8%
|
2
7.4%
|
1
4.5%
|
4
5.3%
|
| Region of Enrollment (participants) [Number] | ||||
| Brazil |
26
100%
|
27
100%
|
22
100%
|
75
100%
|
| score stress (scores on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [scores on a scale] |
63.27
(26.05)
|
66.82
(18.56)
|
54.36
(15.90)
|
61.48
(20.17)
|
Outcome Measures
| Title | Stress Levels After 4 Sessions (2nd Evaluation) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Control Group | Needle Group | Seeds Group |
|---|---|---|---|
| Arm/Group Description | Without intervention | Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation). | They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation). |
| Measure Participants | 22 | 27 | 26 |
| Mean (Standard Deviation) [units on a scale] |
49.68
(17.99)
|
54.69
(27.10)
|
54.00
(25.04)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control Group, Needle Group, Seeds Group |
|---|---|---|
| Comments | Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.352 |
| Comments | The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p<0.05. | |
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -8.0667 | |
| Confidence Interval |
(2-Sided) 95% -76.00 to 23.00 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 17.28 |
|
| Estimation Comments | ||
| Title | Stress Levels(3rd and 4th Evaluation) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 75 participants were assessed |
| Arm/Group Title | Control Group | Needle Group | Seeds Group |
|---|---|---|---|
| Arm/Group Description | Without intervention | Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation). | They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation). |
| Measure Participants | 22 | 27 | 26 |
| 3rd evaluation |
67.87
(25.73)
|
59.84
(23.04)
|
67.10
(23.77)
|
| follow-up |
72.62
(31.51)
|
55.54
(25.26)
|
69.20
(30.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Control Group, Needle Group, Seeds Group |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | It was verified the normality of data distribution and the homogeneity of variance. | |
| Method | ANOVA | |
| Comments | As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -7.9067 | |
| Confidence Interval |
(2-Sided) 95% -67.00 to 37.00 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 19.21 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | one month | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Auriculotherapy by Seeds | Auriculotherapy by Needles | Control Group | |||
| Arm/Group Description | 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. | Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks. | untreated group | |||
All Cause Mortality |
||||||
| Auriculotherapy by Seeds | Auriculotherapy by Needles | Control Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Auriculotherapy by Seeds | Auriculotherapy by Needles | Control Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/27 (0%) | 0/22 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Auriculotherapy by Seeds | Auriculotherapy by Needles | Control Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/26 (3.8%) | 3/27 (11.1%) | 0/22 (0%) | |||
| Psychiatric disorders | ||||||
| abnormal dreams | 1/26 (3.8%) | 1 | 0/27 (0%) | 0 | 0/22 (0%) | 0 |
| increase apettite | 0/26 (0%) | 0 | 1/27 (3.7%) | 1 | 0/22 (0%) | 0 |
| anxiety | 0/26 (0%) | 0 | 1/27 (3.7%) | 1 | 0/22 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| allergy | 0/26 (0%) | 0 | 1/27 (3.7%) | 1 | 0/22 (0%) | 0 |
Limitations/Caveats
Study limitations: small sample size
Bias procedure with auricular seeds: the non-participation of the subject of research in self-massage of the points
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Leonice Fumiko Sato Kurebayashi |
|---|---|
| Organization | University of São Paulo |
| Phone | 55-11-91126023 |
| fumie_ibez@yahoo.com.br |
Responsible Party:
Leonice Fumiko Sato Kurebayashi,
Leonice Fumiko Sato Kurebayashi,
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01141374
Other Study ID Numbers:
- SISNEP
First Posted:
Jun 10, 2010
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013