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Application of Auriculotherapy on Nursing Professional Stress Levels

Primary Purpose

Stress

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
auriculotherapy by needles
auriculotherapy by seeds
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Stress

Eligibility Criteria

23 Years - 61 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Universitário da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group without treatment

Auriculotherapy by needles

Auriculotherapy by seeds

Arm Description

Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group

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.

The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 4, 2010
Last Updated
January 17, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01141374
Brief Title
Application of Auriculotherapy on Nursing Professional Stress Levels
Official Title
Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group without treatment
Arm Type
No Intervention
Arm Description
Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Arm Title
Auriculotherapy by needles
Arm Type
Experimental
Arm Description
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.
Arm Title
Auriculotherapy by seeds
Arm Type
Experimental
Arm Description
The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
Intervention Type
Other
Intervention Name(s)
auriculotherapy by needles
Other Intervention Name(s)
auricular acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
auriculotherapy by seeds
Other Intervention Name(s)
Auricular acupuncture by seeds
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Julia P Silva
Organizational Affiliation
Escola de Enfermagem da Universidade de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitário da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

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Application of Auriculotherapy on Nursing Professional Stress Levels

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