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Trial registered on ANZCTR
Registration number
ACTRN12610000529044
Ethics application status
Approved
Date submitted
25/06/2010
Date registered
30/06/2010
Date last updated
30/06/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of low and high-frequency transcutaneous electric nerve stimulation (TENS) in Post Episiotomy Pain Relief.
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Scientific title
A randomized, controlled trial of effects of low and high-frequency transcutaneous electric nerve stimulation (TENS) in Post Episiotomy Pain Relief.
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Secondary ID [1]
252099
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain from episiotomy
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Condition category
Condition code
Reproductive Health and Childbirth
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
TENS treatment with four silicone-carbon electrodes will placed on the skin next to the episiotomy, i.e. in the puerperae’(mothers who have just given birth), thigh and gluteal muscles region. Puerperae were randomly set into three groups: TENS high-frequency (THF); TENS low-frequency (TLF) and TENS placebo (TP).TENS high-frequency is applied with 100Hz frequency and 100 microseconds pulse. TENS low-frequency is applied with 100Hz frequency and 5 microseconds. The placebo group is identical to the treatment group, but the unit do not provide current. This is a one off intervention with 2 hours the duration.
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Intervention code [1]
256723
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Treatment: Other
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Comparator / control treatment
The placebo group that will submitted the identical to the treatment group, but the TENS unit do not provide current. Pain assessment through numerical rating scale (NRS) will be performe in at the beginning of the study, after TENS and 30 and 60 minutes later.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To evaluate the effectiveness of TENS low and high-frequency as a pain relief resource applied in puerperal women that present episiotomy.
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Assessment method [1]
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Timepoint [1]
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Pain assessment through numerical rating scale (NRS) will be performed in groups at the beginning of the study, after TENS, 30 and 60 minutes later.
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Secondary outcome [1]
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Evaluate if the pain in the episiotomy to interfere on the development of the daily activities.
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Assessment method [1]
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Timepoint [1]
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To check functional capacity, at the beginning of the study, before the TENS, puerperae will be asked about their limite, or not daily activities and about the activities they had not yet performed. These activities will be: sitting, ambulating, urinating, bowel movement, personal hygiene, eating, sleeping and breast-feeding.
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Eligibility
Key inclusion criteria
Low risk pregnancy primiparous, older than 15 years old, literate, understanding the Portuguese Language, aware of time and space, post-natural childbirth, submitted to episiotomy with stitches, presenting pain in the episiotomy, and absence of any genitourinary pathology.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
TENS counter-indications as open wounds, presenting intolerance, irritation or great discomfort on the location where TENS was applied, puerperal relapse or recurrence (increased bleeding requiring intervention, phlogistic signs suggesting infection, fever, anesthesia complications, hypertension, mammary relapse or recurrences, morbid obesity (body weight 100 lb over the ideal weight).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a controlled, double-blind, randomized clinical study that compares three study groups; TENS high-frequency, TENS low-frequency and TENS pacebo. The method in which allocation concealment was performed, i.e. the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed and it was done by central randomization by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table created by a computer software. Randomization was programmed in order to generated a location sequences to endure balance for the number of subjects in each group throughout the study.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
10/08/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Petrolina/Pernambuco
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Pernambuco
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Address [1]
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BR 203 Km 2 s/n Vila Eduardo, Campus Universitario, zip code: 56300-000, Petrolina, Pernambuco.
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Country [1]
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Brazil
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Primary sponsor type
University
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Name
University of Pernambuco
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Address
BR 203 Km 2 s/n Vila Eduardo, Campus Universitario, zip code: 56300-000, Petrolina, Pernambuco.
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Country
Brazil
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Research Ethics Committee of the University of Pernambuco
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Ethics committee address [1]
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Av. Agamenon Magalhaes s/n Santo Amaro, zipe code: 50100-010, Recife, Pernambuco.
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Ethics committee country [1]
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Brazil
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Date submitted for ethics approval [1]
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Approval date [1]
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10/07/2009
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Ethics approval number [1]
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1/09/0145
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Summary
Brief summary
This is a controlled, double-blind, randomized clinical study that compares three study groups; high-frequency TENS, low-frequency TENS and placebo TENS. The objective of this study will be to evaluate the effectiveness of high and low-frequency TENS as a pain relief resource employed in puerperae subjected to natural childbirth with episiotomy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ana Carolina Rodarti Pitangui
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Address
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Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
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Country
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Brazil
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Phone
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+55 87 38666496
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ana Carolina Rodarti Pitangui
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Address
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Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
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Country
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Brazil
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Phone
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+55 87 38666496
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Fax
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Email
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[email protected]
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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.
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