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Ear Acupuncture Effectiveness In Reducing The Signs And Symptoms Of Stress And Anxiety (EAEIRTSOSAA)

This study has been terminated.
Sponsor:
Collaborator:
Santander
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01275989
First received: January 12, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and effective in reducing these levels. The LSS questionnaire and IDATE state were applied before, two months and two and a half months after the start of the applications, the STAI trait was applied once prior to the sessions. The sample comprised 56 individuals who had higher levels of stress above the average LSS 100 students who answered the questionnaires. Participants were divided randomly into three groups: control group with 15 patients without care, intervention group with 20 individuals using specific points for treatment and Group Sham at 21 points using individuals without indication for treatment of anxiety and stress. The results showed that the sham points decreased anxiety levels of participants.


Condition Intervention
Inclusion Criteria:
Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months.
Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form.
Exclusion Criteria:
Pregnant Students.
 Other: Ear acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: EAR ACUPUNCTURE EFFECTIVENESS IN REDUCING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Enrollment: 56
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 21
sham acupuncture
 Other: Ear acupuncture
No Intervention: 15
Control
 Other: Ear acupuncture
Active Comparator: 20
intervention
 Other: Ear acupuncture

Detailed Description:

After checking the levels of stress and anxiety of students and workers from a school of massage and acupuncture concluded that auricular acupuncture in this study had significant results in reducing anxiety levels with the use of points and Ear Handle, but more studies are necessary so that it can be said that these points have sedating and calming effects for anxiety.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Voluntary participation in the study with available time for submission to the sessions, which occur over two months.
  • Have a score of stress medium, high or very high in the LSS questionnaire, completion of the STAI and general form.

Exclusion Criteria:

  • Pregnant students. The only contraindication to this treatment is for pregnant women until the 3rd month of pregnancy
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University São Paulo
ClinicalTrials.gov Identifier: NCT01275989     History of Changes
Other Study ID Numbers: 848/2009
Study First Received: January 12, 2011
Last Updated: January 12, 2011
Health Authority: São Paulo: stress and anxiety

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on October 18, 2012