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Acupuncture in Mothers of Very Low Birth Weight Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Mariana Haddad, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627444
First Posted: June 25, 2012
Last Update Posted: June 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mariana Haddad, University of Sao Paulo
  Purpose
Does ear acupuncture reduce anxiety in mother of very low birth weight infants?

Condition Intervention Phase
Anxiety Procedure: Ear acupuncture Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mariana Haddad, University of Sao Paulo:

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

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Mariana Haddad, Doctorate Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01627444     History of Changes
Other Study ID Numbers: Acupuncture_doctorate
First Submitted: June 20, 2012
First Posted: June 25, 2012
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