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Acupuncture in Mothers of Very Low Birth Weight Infants

Primary Purpose

Anxiety

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ear acupuncture
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Acupuncture, Anxiety, Human Milk, Very low birth weight infants, Mother of very low birth weight infants

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • can read and write in portuguese

Exclusion Criteria:

  • breastfeeding contraindication
  • use of lactogogues

Sites / Locations

  • Hospital Universitário de LondrinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ear acupuncture

Placebo acupuncture

Arm Description

No needle insertion, only stickers on acupuncture points.

Outcomes

Primary Outcome Measures

Reduced anxiety

Secondary Outcome Measures

Full Information

First Posted
June 20, 2012
Last Updated
June 22, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01627444
Brief Title
Acupuncture in Mothers of Very Low Birth Weight Infants
Official Title
Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Acupuncture, Anxiety, Human Milk, Very low birth weight infants, Mother of very low birth weight infants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ear acupuncture
Arm Type
Experimental
Arm Title
Placebo acupuncture
Arm Type
Placebo Comparator
Arm Description
No needle insertion, only stickers on acupuncture points.
Intervention Type
Procedure
Intervention Name(s)
Ear acupuncture
Intervention Description
Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.
Primary Outcome Measure Information:
Title
Reduced anxiety
Time Frame
at least 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: can read and write in portuguese Exclusion Criteria: breastfeeding contraindication use of lactogogues
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana L Haddad, RN, MSc
Phone
55 43 33246030
Email
mari.tradu@gmail.com
Facility Information:
Facility Name
Hospital Universitário de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86038-350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana L Haddad, RN, MSc
Phone
55 43 33246030
Email
mari.tradu@gmail.com
First Name & Middle Initial & Last Name & Degree
Mariana L Haddad, RN, MSc

12. IPD Sharing Statement

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Acupuncture in Mothers of Very Low Birth Weight Infants

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