Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000025932
Ethics application status
Approved
Date submitted
5/01/2011
Date registered
7/01/2011
Date last updated
15/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Ear acupuncture for anxiety in lactating mothers: a randomized controlled trial.
Scientific title
Effect of ear acupuncture for anxiety in very low birth weight infants' mothers compared to standard care.
Secondary ID [1] 253347 0
Approved by the Ethics Commitee of Londrina State University n.o. 379094
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 258883 0
Lactation 258884 0
Condition category
Condition code
Mental Health 259023 259023 0 0
Anxiety
Reproductive Health and Childbirth 259024 259024 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture in five ear points according to the Chinese School - Shen Men, Anxiety 1 and 2, Tension, Muscle Relaxation. Semi-permanent needles will be inserted in an ear weekly, in a procedure the lasts about 5 minutes. The patient should remain with the needles until the next appointment, when the needles will be removed and new ones will be inserted in the other ear. It's expected the acupuncture will present results soon after the first appointment. 2 weeks is the minimum time expected for the participants' babies to start breastfeeding, when that happens it will be no longer possible to measure milk volume, and the study ends for this mother.
Intervention code [1] 257794 0
Treatment: Other
Comparator / control treatment
Placebo acupuncture: tooth pick will be used to simulate needle insertion, without perfurating the skin. Then, a sham needle (semi-permanent needle with blade folded parallel to needle round base) will be placed on ear.
Control group
Placebo

Outcomes
Primary outcome [1] 259876 0
Reduction of anxiety measured by participants' STAI (State-trait anxiety inventory) scores.
Timepoint [1] 259876 0
Before randomization and two weeks after beginning of treatment.
Primary outcome [2] 259877 0
Reduction of anxiety measured by participants' salivary cortisol levels.
Timepoint [2] 259877 0
30 minutes before acupuncture and the morning after acupuncture, at each appointment.
Secondary outcome [1] 268752 0
Increase or maintenance of milk volume produced by participants.
Timepoint [1] 268752 0
Measured daily and weekly.

Eligibility
Key inclusion criteria
Lactating mothers of babies born <1500g (very low birth weight infants) in a school hospital in Londrina.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Important health conditions that counter-indicate breastfeeding, birth complications, multiple gestation, smokers, in use of lactogogues or drugs not-indicated for breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling: mothers of babies born <1500g in a school hospital in Londrina.
Allocation: chronologic order of births, using black envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3118 0
Brazil
State/province [1] 3118 0
Parana

Funding & Sponsors
Funding source category [1] 258263 0
Charities/Societies/Foundations
Name [1] 258263 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 258263 0
Brazil
Primary sponsor type
Individual
Name
Mariana Lourenco Haddad
Address
Rua Alagoas, 1516 apto 4
CEP 86020-430
Londrina - PR
(+55) 43 3324-6030
Country
Brazil
Secondary sponsor category [1] 257431 0
University
Name [1] 257431 0
Escola de Enfermagem de Ribeirao Preto - Universidade de Sao Paulo
Address [1] 257431 0
Av. Bandeirantes, 3900 - Campus Universitario
CEP 14040-902 - Ribeirao Preto - SP
(+55) 16 3602-3394
Country [1] 257431 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260240 0
Human Research Ethics Commitee - Londrina State University
Ethics committee address [1] 260240 0
Rua Robert Koch, 60
Andar Terreo - Predio do Centro de Ciencias da Saude (CSS)Vila Operaria - Londrina- Pr - CEP: 86038440
Ethics committee country [1] 260240 0
Brazil
Date submitted for ethics approval [1] 260240 0
Approval date [1] 260240 0
08/11/2010
Ethics approval number [1] 260240 0
379094

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32052 0
Address 32052 0
Country 32052 0
Phone 32052 0
Fax 32052 0
Email 32052 0
Contact person for public queries
Name 15299 0
Mariana Lourenco Haddad
Address 15299 0
Rua Alagoas, 1526 ap 4
CEP 86020-430
Londrina - Pr - Brasil
Country 15299 0
Brazil
Phone 15299 0
55 43 33246030
Fax 15299 0
Email 15299 0
[email protected]
Contact person for scientific queries
Name 6227 0
Mariana Lourenco Haddad
Address 6227 0
Rua Alagoas, 1526 ap 4
CEP 86020-430
Londrina - Pr - Brasil
Country 6227 0
Brazil
Phone 6227 0
55 43 33246030
Fax 6227 0
Email 6227 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.