Low-level Laser Therapy in Pain and Perineal Healing in the Immediate Postpartum Period: a Randomized Clinical Trial. (LaserPerineal)

Instituto Materno Infantil Prof. Fernando Figueira

Status: Not yet enrolling

Conditions: Perineal Healing; Pain

Treatments: Device: low-level laser therapy; Device: Sham treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07480083

LaserPerineal

92318425.0.0000.5201 (Other Identifier)

Details and patient eligibility

About

This randomized clinical trial aims to evaluate the effectiveness of low-level laser therapy compared with sham treatment on pain intensity and perineal wound healing quality in the immediate postpartum period. The study seeks to determine whether low-level laser therapy can reduce perineal pain and improve healing outcomes in women with perineal trauma after vaginal birth.

Enrollment: 206 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Postpartum women/multiparous women aged 18 years or older;

Postpartum women/multiparous women in the immediate postpartum period after vaginal birth;

Postpartum women/multiparous women with spontaneous perineal laceration (Grade II, III, or IV);

Postpartum women/multiparous women with an average pain score of at least 3 on the Visual Analog Scale (VAS);

Labor duration up to 18 hours.

Exclusion criteria

Postpartum women/multiparous women classified as high-risk during pregnancy due to a diagnosis of gestational diabetes mellitus; type 1 or type 2 diabetes mellitus; chronic or pregnancy-specific hypertension; smoking; alcohol use; use of psychoactive substances, among others;

Postpartum women/multiparous women who present postpartum complications (such as hemorrhage, difficulty in verbal communication, or sepsis);

Postpartum women/multiparous women who develop clinical or hemodynamic complications after childbirth;

Postpartum women/multiparous women whose newborns died or were admitted to a Neonatal Intensive Care Unit (NICU);

Women with communication difficulties (impaired understanding or mental disorders).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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206 participants in 2 patient groups

Experimental group

Experimental group

Description:

low-level laser therapy

Treatment:

Device: low-level laser therapy

Control

Sham Comparator group

Description:

sham treatment

Treatment:

Device: Sham treatment