NCT01275989

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
Last Updated

January 13, 2011

Status Verified

June 1, 2010

Enrollment Period

6 months

First QC Date

January 12, 2011

Last Update Submit

January 12, 2011

Conditions

Study Arms (3)

21

SHAM COMPARATOR

sham acupuncture

Other: Ear acupuncture

15

NO INTERVENTION

Control

Other: Ear acupuncture

20

ACTIVE COMPARATOR

intervention

Other: Ear acupuncture

Interventions

152021

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant students. The only contraindication to this treatment is for pregnant women until the 3rd month of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

March 1, 2010

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

January 13, 2011

Record last verified: 2010-06