Acupuncture for Pain Relief During Induced Labour in Nulliparae: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- the rate of intrapartum epidural analgesia
研究概览
简要总结
The study was primarily designed to assess the role of acupuncture in reducing the need for epidural analgesia for pain relief during induced labour. The other outcomes of labour were to be observed in addition.
详细描述
The study was limited to women in their first pregnancy having labour induced for prolonged pregnancy or mild hypertension. The study involved randomised groups managed with manual acupuncture, electro acupuncture, sham acupuncture and a no-treatment control group.
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, 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
- •nulliparae
- •having labour induced for prolonged pregnancy or mild hypertension
- •no previous experience of acupuncture
- •give written informed consent
排除标准
- •all who do not meet the inclusion criteria
研究组 & 干预措施
manual acupuncture
Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were manually manipulated during this time. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used.
干预措施: acupuncture (Procedure)
electro acupuncture
Sterile needles were inserted intramuscularly to a depth of 15-20mm until an unusual (De-Qi) sensation developed and remained inserted for 30-60 minutes and were either electronically simulated withm2 Hz pulses of 0.5 msec duration for 30 minutes sufficient to cause non-painful muscle contractions. The following bilateral acupoints on the hands and feet at Hegu (LI 4), Sanyinjiao (Sp 6) Kunlun (BL 60) and Zhiyin (BL 67)were used.
干预措施: acupuncture (Procedure)
Sham manual or electro acupuncture
Sterile needles were inserted adjacent to the specific acupuncture sites identified for the manual and electro groups to a depth of 1-1.5mm only and insufficient to provoke an unusual sensation and left in position for a 30-60 minutes. Those randomised to 'sham-manual' received no stimulation and those randomised to 'sham-electro' were connected to the electrical stimulator but the current not activated.
干预措施: acupuncture (Procedure)
control group
Following randomisation to be control group, no specific treatment was organised at this time.
结局指标
主要结局
the rate of intrapartum epidural analgesia
时间窗: within 72 hours of trial entry
epidural analgesia administered during labour
次要结局
- the outcome of labour(within 72 hours of trial entry)
研究者
Ian Mackenzie
Principle investigator
University of Oxford