- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01275989
Ear Acupuncture Effectiveness In Reducing The Signs And Symptoms Of Stress And Anxiety (EAEIRTSOSAA)
January 12, 2011 updated by: University of Sao Paulo
EAR ACUPUNCTURE EFFECTIVENESS IN REDUCING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: 21
sham acupuncture
|
|
NO_INTERVENTION: 15
Control
|
|
ACTIVE_COMPARATOR: 20
intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
January 12, 2011
First Submitted That Met QC Criteria
January 12, 2011
First Posted (ESTIMATE)
January 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 13, 2011
Last Update Submitted That Met QC Criteria
January 12, 2011
Last Verified
June 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 848/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inclusion Criteria:
-
Sanoculis LtdCompletedThis Study is Obtained Under Inclusion/ Exclusion CriteriaArmenia
-
Sanoculis LtdCompletedThis Study is Conducted Under Inclusion/ Exclusion CriteriaArmenia
-
UPECLIN HC FM Botucatu UnespUnknownAdult | Inclusion Criteria: | No Pregnancy | No Lactation | No MorbidityBrazil
-
Poitiers University HospitalCompletedDevelopment Abnormalies | Inclusion on Clinical Criteria of the SyndromeFrance
-
Rabin Medical CenterUnknown
-
Sorin Group CanadaCompletedAny Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA GuidelinesCanada
-
Novartis PharmaceuticalsCompletedSporadic Inclusion Body Myositis (sIBM)United States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University of Southern DenmarkOdense University HospitalCompleted
-
University of Kansas Medical CenterCompletedInclusion Body Myositis | Sporadic Inclusion Body MyositisUnited States
Clinical Trials on Ear acupuncture
-
Taipei City HospitalNational Yang Ming UniversityCompleted
-
University of Sao PauloUnknown
-
Samueli Institute for Information BiologyCompletedMusculoskeletal PainGermany
-
Icahn School of Medicine at Mount SinaiCompletedLow Back PainUnited States
-
Universität Duisburg-EssenKarl and Veronica Carstens FoundationCompletedBreast NeoplasmGermany
-
Samueli Institute for Information BiologyU.S. Army Medical Research and Development Command; Defense Centers of Excellence...CompletedHeadache | Traumatic Brain InjuryUnited States
-
Tianjin Medical University Cancer Institute and...UnknownPancreaticoduodenectomy | Delayed Gastric Emptying | Auricular Acupoint EmbeddingChina
-
Universidade do Sul de Santa CatarinaUniversity of Sao PauloRecruitingDepression | Quality of Life | Insomnia | Anxiety | Depressive SymptomsBrazil
-
Taipei Medical University WanFang HospitalCompletedGastroesophageal Reflux Disease (GERD) | NeurologyTaiwan
-
Universidade Cruzeiro do SulUnknown