Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- Pain scores-30
研究概览
简要总结
ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases.
Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4x0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.
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)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-35
- •37-42 weeks of gestation
- •Expecting vaginal delivery
- •Cephalic presentation
- •Single, healthy fetus
- •Spontaneous onset of labor
- •Active phase of first stage of labor (3-7 cm cervical dilatation)
- •Severe low back pain (VAS>7cm)
- •Required pain relief
排除标准
- •Gestation <37 weeks
- •Multiple pregnancy
- •Malpresentation
- •Second stage labour
- •Pharmacological analgesia prior to SWI
- •Back pain assessed by VAS <7
- •Women whose labour would be considered high risk
结局指标
主要结局
Pain scores-30
时间窗: at 30 mins after interventions
In pain scoring Visual Analog Scale was used
次要结局
- Pain scores-60(at 60 mins after interventions)
- Pain scores-90(at 90 mins after interventions)
- Pain scores-120(at 120 mins after interventions)
- Pain scores-180(at 180 mins after interventions)
- APGAR score of neonate(at 5 mins after birth)
- Rates of breastfeeding-1(at 1 hour after birth)
- Pain scores-10(at 10 mins after interventions)
- Maternal satisfaction(at 1 hour after birth)
- Rates of breastfeeding-24(at 24.hours after birth)
研究者
refika genç koyucu
assist.prof.
University of Beykent