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

Официальное название

Effectiveness of Low-Level Laser Therapy Compared to Sham Treatment on Pain Intensity and Perineal Wound Healing Quality in the Immediate Postpartum Period: A Randomized Clinical Trial

Обзор

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.

Вмешательства

• Устройство low-level laser therapy
  Low-level laser therapy will be applied to the perineal region of postpartum women with perineal trauma after vaginal birth. The intervention will be performed using a low-level laser device applied directly to the perineal wound area in the immediate postpartum period. The laser will be administered according to predefined parameters (wavelength, energy density, and application time) to promote analgesia and enhance tissue repair.
• Устройство Sham treatment
  Participants allocated to the control group will receive a sham treatment using the same device and procedure; however, the laser emission will be inactive.

Первичные конечные точки

• Perineal pain intensity (VAS) (immediate) [Срок оценки: 30 minutes]
• Perineal Pain Intensity (VAS) - 24 hours [Срок оценки: 24 hours]
• Perineal Pain Intensity (VAS) - 48 Hours [Срок оценки: 48 Hours]
• Assessment of wound healing (REEDA) - immediate [Срок оценки: 30 minutes]
• Assessment of Wound Healing (REEDA) - 24 Hours [Срок оценки: 24 Hours]

Вторичные конечные точки (6)

• Need for Pharmacological Analgesia [Срок оценки: 48 hours]
• Global Change Perception Scale (GCPS) Assessment [Срок оценки: 48 Hours]
• Maternal Satisfaction Level [Срок оценки: 48 Hours]
• Adherence to the Intervention [Срок оценки: 48 Hours]
• Adverse Effects of Laser Therapy [Срок оценки: 48 Hours]
• Complications of Perineal Laceration [Срок оценки: 48 Hours]

Критерии участия

Критерии включения

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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto de Medicina Integral Professor Fernando Figueira - IMIP — Recife

Идентификаторы

NCT: NCT07480083 · LaserPerineal · 92318425.0.0000.5201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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