Application of Auriculotherapy on Nursing Professional Stress Levels

Stress Clinical Trial

Official title:

Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141374
• Other study ID #: SISNEP
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2010
• Last updated: January 17, 2013
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 23 Years to 61 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	after 30 days	No
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.	after 60 and 75 days	No