Trial Review

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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.
Scientific title
A randomized, controlled trial of effects of low and high-frequency transcutaneous electric nerve stimulation (TENS) in Post Episiotomy Pain Relief.
Secondary ID [1] 252099 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain from episiotomy 257653 0
Condition category
Condition code
Reproductive Health and Childbirth 257827 257827 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256723 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 258688 0
To evaluate the effectiveness of TENS low and high-frequency as a pain relief resource applied in puerperal women that present episiotomy.
Timepoint [1] 258688 0
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.
Secondary outcome [1] 264709 0
Evaluate if the pain in the episiotomy to interfere on the development of the daily activities.
Timepoint [1] 264709 0
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.

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.
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
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).

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 2726 0
Brazil
State/province [1] 2726 0
Petrolina/Pernambuco

Funding & Sponsors
Funding source category [1] 257200 0
University
Name [1] 257200 0
University of Pernambuco
Country [1] 257200 0
Brazil
Primary sponsor type
University
Name
University of Pernambuco
Address
BR 203 Km 2 s/n Vila Eduardo, Campus Universitario, zip code: 56300-000, Petrolina, Pernambuco.
Country
Brazil
Secondary sponsor category [1] 256456 0
None
Name [1] 256456 0
Address [1] 256456 0
Country [1] 256456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259230 0
Research Ethics Committee of the University of Pernambuco
Ethics committee address [1] 259230 0
Av. Agamenon Magalhaes s/n Santo Amaro, zipe code: 50100-010, Recife, Pernambuco.
Ethics committee country [1] 259230 0
Brazil
Date submitted for ethics approval [1] 259230 0
Approval date [1] 259230 0
10/07/2009
Ethics approval number [1] 259230 0
1/09/0145

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31337 0
Address 31337 0
Country 31337 0
Phone 31337 0
Fax 31337 0
Email 31337 0
Contact person for public queries
Name 14584 0
Ana Carolina Rodarti Pitangui
Address 14584 0
Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
Country 14584 0
Brazil
Phone 14584 0
+55 87 38666496
Fax 14584 0
Email 14584 0
carolpitangui@hotmail.com
Contact person for scientific queries
Name 5512 0
Ana Carolina Rodarti Pitangui
Address 5512 0
Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
Country 5512 0
Brazil
Phone 5512 0
+55 87 38666496
Fax 5512 0
Email 5512 0
carolpitangui@hotmail.com

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
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Documents added automatically
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