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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Perineal pain intensity (VAS) (immediate)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Control
sham treatment
干预措施: Sham treatment (Device)
Experimental group
low-level laser therapy
干预措施: low-level laser therapy (Device)
结局指标
主要结局
Perineal pain intensity (VAS) (immediate)
时间窗: 30 minutes
Perineal pain intensity will be assessed using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest. The assessment will be performed in the immediate postpartum period following the intervention.
Perineal Pain Intensity (VAS) - 24 hours
时间窗: 24 hours
Perineal pain intensity will be assessed 24 hours postpartum using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest at 24 hours after delivery.
Perineal Pain Intensity (VAS) - 48 Hours
时间窗: 48 Hours
Perineal pain intensity will be assessed 48 hours postpartum using the Visual Analog Scale (VAS), a validated instrument ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." Participants will be asked to rate their level of perineal pain at rest 48 hours after delivery.
Assessment of wound healing (REEDA) - immediate
时间窗: 30 minutes
Perineal wound healing will be assessed using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, and Approximation), a validated instrument used to evaluate the healing process of perineal trauma. Each item is scored from 0 to 3, with total scores ranging from 0 to 15, where lower scores indicate better healing. The assessment will be performed in the immediate postpartum period following the intervention.
Assessment of Wound Healing (REEDA) - 24 Hours
时间窗: 24 Hours
Perineal wound healing will be assessed 24 hours postpartum using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, and Approximation), a validated instrument used to evaluate the healing process of perineal trauma. Each item is scored from 0 to 3, with total scores ranging from 0 to 15, where lower scores indicate better healing. The assessment will be performed 24 hours after delivery.
次要结局
- Complications of Perineal Laceration(48 Hours)
- Adverse Effects of Laser Therapy(48 Hours)
- Need for Pharmacological Analgesia(48 hours)
- Global Change Perception Scale (GCPS) Assessment(48 Hours)
- Maternal Satisfaction Level(48 Hours)
- Adherence to the Intervention(48 Hours)
研究者
Leila Katz
PhD
Instituto Materno Infantil Prof. Fernando Figueira