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Acupuncture in Mothers of Very Low Birth Weight Infants

This study is currently recruiting participants.
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Mariana Haddad, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01627444
First received: June 20, 2012
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Reduced anxiety [ Time Frame: at least 2 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mariana Haddad, Doctorate Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01627444     History of Changes
Other Study ID Numbers: Acupuncture_doctorate
Study First Received: June 20, 2012
Last Updated: June 22, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013