Acupuncture in Mothers of Very Low Birth Weight Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
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
  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:


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
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, see Learn About Clinical Studies.

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 September 18, 2014