- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627444
Acupuncture in Mothers of Very Low Birth Weight Infants
June 22, 2012 updated by: Mariana Haddad, University of Sao Paulo
Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants
Does ear acupuncture reduce anxiety in mother of very low birth weight infants?
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Paraná
-
Londrina, Paraná, Brazil, 86038-350
- Recruiting
- Hospital Universitário de Londrina
-
Contact:
- Mariana L Haddad, RN, MSc
- Phone Number: 55 43 33246030
- Email: mari.tradu@gmail.com
-
Principal Investigator:
- Mariana L Haddad, RN, MSc
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- can read and write in portuguese
Exclusion Criteria:
- breastfeeding contraindication
- use of lactogogues
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ear acupuncture
|
Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.
|
Placebo Comparator: Placebo acupuncture
No needle insertion, only stickers on acupuncture points.
|
Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduced anxiety
Time Frame: at least 2 weeks
|
at least 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2011
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
June 20, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimate)
June 25, 2012
Study Record Updates
Last Update Posted (Estimate)
June 25, 2012
Last Update Submitted That Met QC Criteria
June 22, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acupuncture_doctorate
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.
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