Acupuncture in Mothers of Very Low Birth Weight Infants

Anxiety Clinical Trial

Official title:

Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01627444
• Other study ID #: Acupuncture_doctorate
• Status: Recruiting
• Phase: Phase 2
• First received: June 20, 2012
• Last updated: June 22, 2012
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: June 2012
• Source: University of Sao Paulo
• Contact: Mariana L Haddad, RN, MSc
• Phone: 55 43 33246030
• Email: mari.tradu[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• can read and write in portuguese

Exclusion Criteria:

• breastfeeding contraindication

• use of lactogogues

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Birth Weight

Intervention

Procedure:
• Ear acupuncture
Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Londrina	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced anxiety		at least 2 weeks	No