Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000644066
Ethics application status
Approved
Date submitted
5/08/2010
Date registered
9/08/2010
Date last updated
9/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of transcutaneous electrical nerve stimulation for painful postpartum uterine contraction during brestfeeding
Scientific title
Application of transcutaneous electrical nerve stimulation (TENS) in multiparous for pain relief of uterine contractionduring breastfeeding in immediate postpartum: a randomized controlled trial
Secondary ID [1] 252389 0
NONE
Universal Trial Number (UTN)
U1111-1116-3983
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
painful uterine contraction 257890 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258051 258051 0 0
Physiotherapy
Reproductive Health and Childbirth 258065 258065 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcutaneous electrical nerve stimulation (TENS) - frequency of 80 Hz, pulse duration of 100 microseconds and intensity adjusted by the participant as strong and tolerable, producing a tingling sensation. This intervention happens once every participant in the TENS group, for a continuous period of 40 minutes during breastfeeding.
Intervention code [1] 256942 0
Treatment: Devices
Comparator / control treatment
For the treatment control, no treatment was given to the control group participants.
Control group
Active

Outcomes
Primary outcome [1] 258927 0
Primary outcome 1: 2-point reduction in pain scores by the numeric rating scale after use of TENS.
Timepoint [1] 258927 0
Timepoints 1: evolution after breastfeeding.
Secondary outcome [1] 265075 0
Secondary outcomes 1: satisfaction with TENS treatment through a questionnaire of satisfaction (very satisfied, satisfied, little satisfied, unsatisfied).
Timepoint [1] 265075 0
Timepoints 1: after use of TENS for the participants.
Secondary outcome [2] 265076 0
Secondary outcomes 2: use of TENS in the next brestfeedings through a questionnarie (yes ou no).
Timepoint [2] 265076 0
Timepoints 2: after use of TENS for the participants.
Secondary outcome [3] 265077 0
Secondary outcomes 3: discomfort produced by TENS through a questionnaire of discomfort (no discomfort, mild discomfort, moderate discomfort, severe discomfort, discomfort worst possible).
Timepoint [3] 265077 0
Timepoints 3: after use of TENS for the participants.

Eligibility
Key inclusion criteria
The inclusion criteria of the research are: women after vaginal delivery, multiparity, without complications postpartum, pain level greater than "one" by Numeric Rating Scale Pain, literate, capable of understanding the pain scales used and follow the procedures of motherhood.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for research are: intolerance stimulus generated by the use of electrical stimulation and allergy to the use of electrode, pacemaker, complications that require medical intervention, such as bleeding, infection and others.

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)
Women were selected in the immediate postpartum during breastfeeding that reported pain level greater "one" by numeric rating scale and who agree to participate of the research. The participants were designated to the TENS group or control group according to the randomization plan previously generated by computer program. After accept to participate in research, the participants was informed by the researcher which group was entered.The allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The groups are randomly assigned by a computer program generating randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 2804 0
Brazil
State/province [1] 2804 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257393 0
University
Name [1] 257393 0
Escola de Enfermagem de Ribeirao Preto da Universidade de Sao Paulo
Country [1] 257393 0
Brazil
Primary sponsor type
Individual
Name
Ligia de Sousa
Address
Avenida dos bandeirantes, 3900. Monte Alegre. Ribeirao Preto/SP. CEP:14040-030.
Country
Brazil
Secondary sponsor category [1] 256629 0
Individual
Name [1] 256629 0
Ana Marcia Spano Nakano
Address [1] 256629 0
Avenida dos bandeirantes, 3900. Monte Alegre. Ribeirao Preto/SP. CEP:14040-030.
Country [1] 256629 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259416 0
Ethics committee of the School of Nursing at Ribeirao Preto
Ethics committee address [1] 259416 0
Ethics committee country [1] 259416 0
Brazil
Date submitted for ethics approval [1] 259416 0
Approval date [1] 259416 0
Ethics approval number [1] 259416 0

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

Contacts
Principal investigator
Name 31475 0
Address 31475 0
Country 31475 0
Phone 31475 0
Fax 31475 0
Email 31475 0
Contact person for public queries
Name 14722 0
Ligia de Sousa
Address 14722 0
Acre, 751. Sao Francisco. Catanduva/SP. CEP: 15.806-155
Country 14722 0
Brazil
Phone 14722 0
55-17-81217975
Fax 14722 0
none
Email 14722 0
[email protected]
Contact person for scientific queries
Name 5650 0
Ana Marcia Sapno Nakano
Address 5650 0
Avenida dos Bandeirantes, 3900. Monte Alegre. Ribeirao Preto/SP. CEP: 14049-902
Country 5650 0
Brazil
Phone 5650 0
55-16-36023405
Fax 5650 0
Email 5650 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.