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临床试验/NCT06370910
NCT06370910已完成不适用

Comparison of Low-Level Laser Therapy With Cryotherapy in Postpartum Women With Laceration and/or Episiotomy on Perineal and Vulvar Pain Reduction

Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
To compare two techniques: Low-level laser and cryotherapy

研究概览

简要总结

The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.

Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.

Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.

Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery.

详细描述

Faced with the scarcity of evidence indicating the best approach to reducing edema and relieving pain in the postpartum period, there is a need to evaluate new methods for pain relief during this time to ensure better well-being for women in the postpartum period.

Lacerations and episiotomies, which can occur during vaginal delivery, exacerbate this pain, making it even more necessary to utilize resources to alleviate discomfort and perineal and vulvar edema, which can consequently worsen pain.

The postpartum period is challenging, with numerous adjustments, and pain can be debilitating, making this period particularly challenging. However, it is possible to minimize it with non-pharmacological interventions.

Cryotherapy has proven to be a valuable resource already utilized in the immediate postpartum period, and low-intensity laser therapy has also demonstrated effectiveness in pain relief, both with low associated risks and costs.

Therefore, it is crucial to compare which therapeutic approach is most effective during the immediate postpartum period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient who underwent vaginal delivery;
  • Had a grade 1 or grade 2 laceration;
  • Have undergone episiotomy;

排除标准

  • Patient who underwent cesarean section;
  • With Help Syndrome;
  • They presented immediate postpartum hemorrhage;
  • They had unstable vital signs in the immediate postpartum period;

结局指标

主要结局

To compare two techniques: Low-level laser and cryotherapy

时间窗: 24 horas

The use of low-level laser therapy or cryotherapy to alleviate pain. Cryotherapy was performed using a glove containing crushed ice, applied to the perineal region for 20 minutes, initiated within 12 hours postpartum. Patients were evaluated before the application, immediately after the application, and 24 hours after the application. Low-level laser therapy, as well as cryotherapy, was applied within 12 hours after delivery, targeting the site of the injury with red radiation. The applied dose was 3 joules, administered in a punctual manner, using a non-contact technique, with a distance of 2 cm between each point. Subsequently, infrared laser therapy was applied using conventional contact technique around the extent of the injury, with a punctual application of 6 joules, also maintaining a distance of 2 cm between each point.

次要结局

  • Evaluate reduction of swelling using the REEDA scale.(24 hours)
  • Pain reduction assessed by McGill Pain Scale(24 hours)
  • Pain reduction assessed by the Visual Analog Scale (VAS).(24 hours)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elen Cristine Boniatti Constant

Investigador Principal

Federal University of Rio Grande do Sul

研究点 (2)

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