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Photobiomodulation for pain relief, edema reduction and perineal laceration healing in the immediate postpartum period

The use of Low Power Laser in pain relief, reducing edema and screening of perineal laceration in the immediate post birth

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-103nwkfy
Enrollment
Unknown
Registered
2022-02-24
Start date
2021-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The treatment will follow safety measures regarding the dosometry used in the study region, based on daily visits to the Barral and Barral polyclinics and scientific studies, the doses used correspond to the safest possible, thus obeying the coloration of the vaginal mucosa, cleaning the portable device with laser therapy, the equipment will be disinfected, and support materials (pillows) will be made with 70% alcohol before and after each application. You will use procedure gloves and EPis duri

Interventions

Postpartum postpartum women who have undergone grade I and II perineal laceration without suture and III, IV with episiorraphy will be selected. Based on a 2019 productivity spreadsheet, the study pop
E02.594.540

Sponsors

cis+ centro integrado de saude
Collaborator
Secretaria Municipal de Saúde de Rio Branco
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: This study will include postpartum women of immediate vaginal birth aged 18 to 40 years, with perineal laceration I and II without suture and III, IV with episiorraphy, without clinical or obstetric complications, without associated pathologies, literate and showing good physical condition and mental.

Exclusion criteria

Exclusion criteria: This study excludes puerperal women undergoing vaginal delivery who have undergone episiotomy.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1 is a randomized controlled clinical trial, which sought to investigate the effectiveness of the applicability of low-level laser therapy in perineal lacerations resulting from vaginal delivery (16). As the primary outcome of this research, it is about verifying the improvement of pain perception after treatment, the instruments needed for the research were: evaluation form prepared by the researcher based on evaluation instruments of the Ministry of Health, and standard evaluation form of postpartum (4); Visual Analog Scale numbered from 0 to 10 (VAS) (18). The therapeutic window of the present study was guided by a study carried out by Pinheiro et al (2015), which used tissue modulation in the infrared aspect (810 nm) with 100 mW of power and a dose of 6 J/cm2, divided into four applications of 1.5 J/cm²: aiming at analgesia showing a significant result when compared to the control group (17). The protocol shown in Table 01 consisted of therapy using low-level laser, using equipment model THERAPY EC serial number: 17514 with calibration certificate No. OS34483SN17514 from the MDC brand, with applicability of VAS in the first hour after vaginal delivery in both groups, experimental and control, followed by application of low-level laser in the experimental group and 20 hours after delivery, VAS was measured in both groups studied. Table 1 – Specification of the treatment protocol. Parameters Red protocol Infrared protocol Wavelength(nm) 660 808 Operating mode Continuous Continuous Peak power (W) 100 100 Joules (area) 2cm2 2 cm2 Application time 20 s 20 s Circular Circular Beam Shape Gaussian beam profile Gaussian Application technique Contact Contact Number of points 08 08 Frequency of sessions 1h after delivery assessed by VAS before therapy and 20h after 1h after delivery, assessed by VAS before therapy and 20h after; Endpoint found 1 Postpartum women aged 18 to 40 years with a mean age of 23.9 ± 6.3 years were included in the study, without cl

Secondary

MeasureTime frame
Seeking to further analyze the variables involved in the perception of pain, a correlation matrix was created to identify which variables may be associated with the explanation of pain. The Laceration Degree (corr = 0.25) stood out for the analysis, considered a weak correlation, but relevant to the study. Describing the attribute under analysis, Degree of Laceration, it has a subdivision into three groups (1 – Mild, 2 – Moderate and 3 – High). Thus, Level 1 = 37 postpartum women, Level 2 = 18, Level 3 = 4, and the experimental group, Level 1 = 35 postpartum women, Level 2 = 18, Level 3 = 4 were observed. homogeneity between groups and that lower degrees of lacerations are more frequent than higher ones. To answer the question whether the degree of laceration influences the perception of pain, a Student's t test was performed for dependent samples. The results showed that people not submitted to LASER did not present differences in the before and after, for any degree of laceration (p > 0.01). In the Experimental group, LASER proved to be useful in reducing pain perception, especially in women with grade 1 laceration. The low numbers of women with grades 2 and 3 did not allow the application of the test to investigate a significant difference between the groups before and after for a cut-off value of 0.01. However, for the cut-off value of 0.05, the groups show a significant difference, with the respective cohen's d (1.23; 0.97; 2.67) being high effect sizes. Investigating the influence of birth position on pain perception, it is noted that the groups are well distributed among each category. Using a Student's t-test for dependent samples, the values ??for the Lateral (p = 0.37) and Semi-sitting (p = 0.81) positions were obtained, and it was not possible to find a significant difference between the groups before and after the application of the test. LASER. It was evidenced that the level of pain perception is independent of the delivery position. Here it was not

Countries

Brazil

Contacts

Public ContactAdna Maia

Secretaria Municipal de Saúde de Rio Branco

adnamaia@hotmail.com+5568992057646

Outcome results

None listed

Source: REBEC (via WHO ICTRP)