NCT01627444

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 anxiety

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 20, 2012

Last Update Submit

June 22, 2012

Conditions

Anxiety

Keywords

AcupunctureAnxietyHuman MilkVery low birth weight infantsMother of very low birth weight infants

Outcome Measures

Primary Outcomes (1)

  • Reduced anxiety

    at least 2 weeks

Study Arms (2)

ear acupuncture

EXPERIMENTAL
Procedure: Ear acupuncture

Placebo acupuncture

PLACEBO COMPARATOR

No needle insertion, only stickers on acupuncture points.

Procedure: Ear acupuncture

Interventions

Ear acupuncturePROCEDURE

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

Placebo acupunctureear acupuncture

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • can read and write in portuguese

You may not qualify if:

  • breastfeeding contraindication
  • use of lactogogues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário de Londrina

Londrina, Paraná, 86038-350, Brazil

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Central Study Contacts

Mariana L Haddad, RN, MSc

CONTACT

55 43 33246030mari.tradu@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorate Student

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 25, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

BR(1)