CClinicalTrials.gg
Status unknownNCT01627444Updated Jun 25, 2012

Acupuncture in Mothers of Very Low Birth Weight Infants

A Phase 2 interventional study of Ear acupuncture in Anxiety, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-25.

Sponsored by University of Sao Paulo · Phase 2, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Anxiety

Keywords

  • Acupuncture
  • Anxiety
  • Human Milk
  • Very low birth weight infants
  • Mother of very low birth weight infants
03

In context

Birth Weight

445 studies on the registry are indexed under Birth Weight; 36 are open to participants now.

This study's planned enrollment of 20 is below the median of 110 across 297 interventional studies indexed under Birth Weight.

Browse Birth Weight studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • can read and write in portuguese

Exclusion criteria

Exclusion Criteria:

  • breastfeeding contraindication
  • use of lactogogues
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    ear acupuncture

    Procedure: Ear acupuncture

  • Placebo comparator
    Placebo acupuncture

    No needle insertion, only stickers on acupuncture points.

    Procedure: Ear acupuncture

Interventions

  • ProcedureEar acupuncture

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

06

What researchers measure

Primary outcomes

  1. Reduced anxiety

    Time frame: at least 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitário de Londrina
    Londrina, Paraná 86038-350, Brazil
    • Mariana L Haddad, RN, MSc · Contact · mari.tradu@gmail.com · 55 43 33246030
    • Mariana L Haddad, RN, MSc · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01627444
Lead sponsor
University of Sao Paulo
Responsible party
Mariana Haddad (Doctorate Student, University of Sao Paulo) — Principal investigator
First posted
Jun 25, 2012
Start date
Aug 2011
Primary completion
Aug 2012 (estimated)
Completion
Aug 2012 (estimated)
Last update
Jun 25, 2012

Study contacts

Mariana L Haddad, RN, MSc
Contact
mari.tradu@gmail.com
55 43 33246030
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion