Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- pain intensity difference between the first analgesic procedure and 30min later
研究概览
简要总结
The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total.
Cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births.
At Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol.
What these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy.
In recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies.
It therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly.
If virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Parturient over 18
- •Parturient who speaks and understands French
- •Parturient hospitalised prior to labour
- •Membranes intact or ruptured
- •Spontaneous or induced labour
- •Parturient in latency phase
- •Term ≥ 37SA
- •Parturient requiring active pain management (medicinal or non-medicinal)
- •Low-risk pregnancy
排除标准
- •Parturient under legal protection
- •Parturient with a hearing impairment
- •Parturient with visual impairment
- •Parturient with epilepsy
- •Parturient with psychiatric problems
- •Pathological pregnancy
- •Parturient with chronic pain
- •Parturient with addiction-related disorders
- •Parturient allergic to paracetamol
- •Parturient allergic to phloroglucinol
- •Parturient allergic to codeine
- •Parturient allergic to nalbuphine
- •Parturient allergic to orozamudol
研究组 & 干预措施
control group
干预措施: painkiller (Drug)
hypnosis group
干预措施: hypnosis group (Other)
结局指标
主要结局
pain intensity difference between the first analgesic procedure and 30min later
时间窗: 30 minutes
Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.
次要结局
- Average consumption of analgesics(12 hours)
