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Acupuncture in Mothers of Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT01627444
Recruitment Status : Unknown
Verified June 2012 by Mariana Haddad, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Mariana Haddad, University of Sao Paulo

Brief Summary:
Does ear acupuncture reduce anxiety in mother of very low birth weight infants?

Condition or disease Intervention/treatment Phase
Anxiety Procedure: Ear acupuncture Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants
Study Start Date : August 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ear acupuncture Procedure: 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.
Procedure: Ear acupuncture
Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.



Primary Outcome Measures :
  1. Reduced anxiety [ Time Frame: at least 2 weeks ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • can read and write in portuguese

Exclusion Criteria:

  • breastfeeding contraindication
  • use of lactogogues

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627444


Contacts
Contact: Mariana L Haddad, RN, MSc 55 43 33246030 mari.tradu@gmail.com

Locations
Brazil
Hospital Universitário de Londrina Recruiting
Londrina, Paraná, Brazil, 86038-350
Contact: Mariana L Haddad, RN, MSc    55 43 33246030    mari.tradu@gmail.com   
Principal Investigator: Mariana L Haddad, RN, MSc         
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Mariana Haddad, Doctorate Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01627444     History of Changes
Other Study ID Numbers: Acupuncture_doctorate
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by Mariana Haddad, University of Sao Paulo:
Acupuncture
Anxiety
Human Milk
Very low birth weight infants
Mother of very low birth weight infants

Additional relevant MeSH terms:
Anxiety Disorders
Birth Weight
Mental Disorders
Body Weight
Signs and Symptoms