Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000471088
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
9/06/2010
Date last updated
9/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effect of the transcutaneous electric nerve stimulation (TENS) in the relief of post-episiotomy pain in primiparous new mothers submitted to the spontaneous vaginal delivery.
Scientific title
High-Frequency transcutaneous electric nerve stimulation (TENS) in Post Episiotomy Pain Relief in Primiparous Puerperae: A randomized, controlled trial.
Secondary ID [1] 251939 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain from episiotomy 257513 0
Condition category
Condition code
Reproductive Health and Childbirth 257673 257673 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. TENS is applied with 100Hz frequency and 75 microseconds pulse for 60 minutes. This is a one off intervention.
Forty puerperae were randomly set into two groups: TENS and control.
Intervention code [1] 256607 0
Treatment: Other
Comparator / control treatment
A control group was composed from primiparous puerperae with episiotomy and feeling perineal pain. The control group that was submitted to the routine procedures (eg. drugs such as dipyrone) the institution. Pain assessment through numerical rating scale (NRS) will be performe in at the beginning of the study, after TENS and 60 minutes later.
Control group
Active

Outcomes
Primary outcome [1] 258578 0
To evaluate the effectiveness of TENS as a pain relief resource applied in puerperal women that present episiotomy.
Timepoint [1] 258578 0
Post episiotomy pain was assessed while resting, sitting and ambulating through a Numeric Rating Scale (NRS) and the McGill pain questionnaire (MPQ). Pain assessment through NRS was be performed in both groups at the beginning of the study, after TENS and 60 minutes later.
Secondary outcome [1] 264446 0
To characterized the painful complaint and evaluate if the pain in the episiotomy to interfere on the development of the daily activities.
Timepoint [1] 264446 0
The Brazilian version of the McGill pain questionnaire (MPQ) was employed before and after TENS to characterize the pain. To check functional capacity, at the beginning of the study, puerperae was asked about their limite, or not daily activities and about the activities they had not yet performed. These activities were: sitting, ambulating, urinating, bowel movement, personal hygiene, eating, sleeping and breast-feeding.

Eligibility
Key inclusion criteria
Low risk pregnancy primiparous, older than 18 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
18 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, single-blind, randomized clinical study that compares two study groups; high-frequency TENS and control. Forty primiparous puerperae submitted to natural childbirth with episiotomy in a Brazilian Maternity took part in this study. 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. The number of patients in each group was equal.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pain assessment through NRS was performed in both groups at the beginning of the study, after TENS and 60 minutes later. MPQ will be employe before and after TENS. TENS with 100Hz frequency and 75 microsecond pulse for 60 minutes was employe without causing any pain. Four electrodes was place near the episiotomy, in the pudendal and genitofemoral nerves that supplied the perineal area.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2679 0
Brazil
State/province [1] 2679 0

Funding & Sponsors
Funding source category [1] 257101 0
Government body
Name [1] 257101 0
The national council for scientific and tecnological development (CNPq)
Country [1] 257101 0
Brazil
Primary sponsor type
University
Name
Escola de Enfermagem de Ribeirao Preto da Universidade de Sao Paulo
Address
Av. dos Bandeirantes, 3900 - Monte Alegre - Ribeirao Preto, SP - Zip code: 14.040-902
Country
Brazil
Secondary sponsor category [1] 256361 0
None
Name [1] 256361 0
Address [1] 256361 0
Country [1] 256361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259134 0
Ethics Committee of the Nursing School of Ribeirao Preto in the University of Sao Paulo, USP, Brazil.
Ethics committee address [1] 259134 0
Ethics committee country [1] 259134 0
Brazil
Date submitted for ethics approval [1] 259134 0
Approval date [1] 259134 0
04/07/2006
Ethics approval number [1] 259134 0
0665/2006

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

Contacts
Principal investigator
Name 31255 0
Address 31255 0
Country 31255 0
Phone 31255 0
Fax 31255 0
Email 31255 0
Contact person for public queries
Name 14502 0
Ana Carolina Rodarti Pitangui
Address 14502 0
Jose Francisco de Almeida Street, no 216, ap 202, zip code: 56330-545, Petrolina, Pernambuco.
Country 14502 0
Brazil
Phone 14502 0
+55 87 3866-6496
Fax 14502 0
Email 14502 0
[email protected]
Contact person for scientific queries
Name 5430 0
Ana Carolina Rodarti Pitangui
Address 5430 0
Jose Francisco de Almeida Street, no 216, ap 202, zip code: 56330-545, Petrolina, Pernambuco.
Country 5430 0
Brazil
Phone 5430 0
+55 87 3866-6496
Fax 5430 0
Email 5430 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.