Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001048279
Ethics application status
Approved
Date submitted
24/11/2009
Date registered
8/12/2009
Date last updated
8/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of low-level laser therapy for relieving pain from episiotomy after birth.
Scientific title
Effectiveness of low-level laser therapy for relieving pain from episiotomy in healthy women after birth .
Secondary ID [1] 1166 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain from episiotomy. 252270 0
Condition category
Condition code
Reproductive Health and Childbirth 252456 252456 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Irradiation with low-level laser in healthy women after episiotomy feeling perineal pain. The irradiation were applied in one single session in the episiotomy in three different points during 10 seconds in each point, using the low level laser with different waves lengths and with the sames doses: 35mW and 8,8J/cm2.
Group one, using low-level laser with wave length infrared (780nm) and Group two using red light (660nm).
Intervention code [1] 241597 0
Treatment: Other
Comparator / control treatment
A control or 'sham' group was composed from healthy women with episiotomy and feeling perineal pain. The sham laser applied to three different points during 10 seconds in each point in one single session.
Control group
Placebo

Outcomes
Primary outcome [1] 253326 0
To evaluate the perineal pain before and after the irradiation with low-level laser. The Visual Analogue Scale (VAS) was applied to assess the perineal pain.
Timepoint [1] 253326 0
The perineal pain were evaluated before and immediately after of the irradiation in the episiotomy in the three groups using the Visual Analogue Scale (VAS).
Secondary outcome [1] 262404 0
To evaluate if the pain in the episiotomy to interfere on the development of the daily activities. A questionnaire indicating if the woman felt pain of 20 until 48 hours after the childbirth to sit, to walk, to evacuate, to urinate and to breastfeed was applied.
Timepoint [1] 262404 0
To evaluate if the pain in the episiotomy to interfere on the development of the daily activities before and after of the irradiation. A questionnaire indicating if the woman felt pain of 20 until 48 hours after the childbirth to sit, to walk, to evacuate, to urinate and to breastfeed was applied.

Eligibility
Key inclusion criteria
Healthy women with perineal pain grater or equal 3 in the Visual Analogue Scale (VAS), with or without previous delivery, with singleton pregnancy, cephalic presentation, gestation greater than or equal to 37 weeks, the women did not receive medication analgesic in the last 6 hours, without hemorrhoids and without evidence of complications clinics.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the woman to use any another product in the perineal, different of water and soap.

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)
The women were randomly distributed into three groups as follows: group infrared (Group 1: the low-level laser with wave length infrared (780nm), group red (group 2: with low-level laser with wave length red (660nm) and control group (no treatment or 'sham'). The subjects was elegible for inclusion in the trial and was blinded. The allocation was done by sealed opaque envelopes before the irradiation. One person was responsible for application and another researcher (blinded) was responsible for the evaluation of perineal pain.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to create the random order for the allocation of subjects into three differents groups was the simple randomisation using a randomisation table created by a computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The treatments were carried once after the episiotomy at three points within the injury area. The dose per point was 8,8J/cm2 in the red and infrared group. The perineal pain was evaluated using the numerical scale for the pain (0 of 10) before and immediatly after the irradiation, for a blinded researcher.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment outside Australia
Country [1] 2337 0
Brazil
State/province [1] 2337 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 244076 0
University
Name [1] 244076 0
Escola de Enfermagem da Universidade de Sao Paulo
Country [1] 244076 0
Brazil
Primary sponsor type
Charities/Societies/Foundations
Name
FAPESP - Fundacao de Amparo a Pesquisa de Sao Paulo.
Address
S: Pio XI, 1500 - Alto da Lapa.
CEP 05468-901 - Sao Paulo - SP.
Country
Brazil
Secondary sponsor category [1] 251421 0
None
Name [1] 251421 0
Address [1] 251421 0
Country [1] 251421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258173 0
Comite de Etica em Pesquisa da Escola de Enfermagem da Universidade de Sao Paulo.
Ethics committee address [1] 258173 0
Ethics committee country [1] 258173 0
Brazil
Date submitted for ethics approval [1] 258173 0
Approval date [1] 258173 0
22/12/2008
Ethics approval number [1] 258173 0
778/2008

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

Contacts
Principal investigator
Name 30545 0
Address 30545 0
Country 30545 0
Phone 30545 0
Fax 30545 0
Email 30545 0
Contact person for public queries
Name 13792 0
Jaqueline de Oliveira Santos
Address 13792 0
Avenida Conselheiro Rodrigues Alves, 127.
CEP 04014-010. Vila Mariana, Sao Paulo - SP.
Country 13792 0
Brazil
Phone 13792 0
+55 11 8100 0111
Fax 13792 0
Email 13792 0
[email protected]
Contact person for scientific queries
Name 4720 0
Sonia Maria Junqueira Vasconcellos de Oliveira
Address 4720 0
Escola de Enfermagem da Universidade de Sao Paulo
Avenida Doutor. Eneas de Carvalho Aguiar, 419 - 05403-000 - Sao Paulo - SP
Country 4720 0
Brazil
Phone 4720 0
+55 11 3061 7602
Fax 4720 0
Email 4720 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.