Prospective Double Blind Controlled Trial of Low Level Laser Therapy - Cesarean Section or Vaginal Tear or Episiotomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Prospective randomized double blind study. Intervention 1: Low-level laser therapy ca. 72 Joules vs. Intervention 2: No Low-level laser therapy.
Outcome: Pain score & would healing at discharge, 1 months & 3 months
详细描述
After surgical suture application of low level laser therapy of ca. 72 Joules / cm2.
Evaluation at discharge, after 1 months & 3 months.
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, Care Provider, Investigator)
盲法说明
Blinding of the two laser pens is in place till all patient data has been collected.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Caesarean section or perineal tear grade 1-4 or episiotomy
- •competent in German language
排除标准
- •no caesarean section or birth without perineal tear grad 1-4 / episiotomy
- •No consent given
研究组 & 干预措施
Low-level laser therapy
Laser pen with low-level laser therapy.
干预措施: Low-level laser therapy (Device)
Sham no low-level laser therapy
Identical laser pen without the low-level laser production.
干预措施: "Fake" low-level laser therapy (Device)
结局指标
主要结局
Pain score
时间窗: Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth
Visual analog scale (1= no pain; 10 = severe pain)
次要结局
- subjective would healing(Questionnaire 3 to 4 days after birth, after 1 month after birth & after 3 months after birth)
研究者
Prof. Dr. Joscha Reinhard
Specialist registrar
St. Elisabethen Krankenhaus Frankfurt GmbH