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Application of Auriculotherapy on Nursing Professional Stress Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01141374
First received: June 4, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.


Condition Intervention Phase
Stress
 Other: auriculotherapy by needles
Other: auriculotherapy by seeds
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Stress Levels After 4 Sessions (2nd Evaluation) [ Time Frame: after 30 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: after 60 and 75 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: auricular acupuncture
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 Name: Auricular acupuncture by 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.

  Eligibility

Ages Eligible for Study:   23 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141374

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01141374     History of Changes
Other Study ID Numbers: SISNEP
Study First Received: June 4, 2010
Results First Received: August 20, 2011
Last Updated: January 17, 2013
Health Authority: Brazil: Ethics Committee
United States: Food and Drug Administration

Keywords provided by University of Sao Paulo:
Stress

ClinicalTrials.gov processed this record on May 16, 2013