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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01275989
Other study ID # 848/2009
Secondary ID
Status Terminated
Phase N/A
First received January 12, 2011
Last updated January 12, 2011
Start date March 2010
Est. completion date November 2010

Study information

Verified date June 2010
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority São Paulo: stress and anxiety
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 56
Est. completion date November 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Ear acupuncture


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Santander
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