The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- State anxiety by STAI-Y-A scale
研究概览
简要总结
This research investigates the impact of a hypnosis-based intervention in alleviating state anxiety in Preterm Premature Rupture of Membranes (PPROM). Our main hypothesis is that a two-session intervention can decrease anxiety for pregnant women with PPROM compared to usual care. This research also studies the impact of the experience of a PPROM during a pregnancy on several variables such as perinatal depression, pregnancy-related anxiety, bonding and childbirth experience, as well as control and pain perceived during chilbirth. Our hypotheses are that the experience of PPROM negatively influences these variables, and that this impact is alleviated by the hypnosis-based intervention for the experimental group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Being an adult French-speaking woman,
- •primi or multipara,
- •less than 33 weeks and 6 days of amenorrhea
- •having being diagnosed with PPROM
排除标准
- •Women cognitively impaired or with important hearing issues,
- •being placed under protective measures,
- •caring more than one fetus,
- •having a severe, preexisting or triggered during the pregnancy,
- •psychiatric pathology,
- •caring a fetus with an abnormality having required further medical investigations, or participating in another clinical trial comprising an intervention measuring psychological variables
结局指标
主要结局
State anxiety by STAI-Y-A scale
时间窗: between baseline and 3-week (+/- 1 week) prenatal measurement
change in anxiety-status level between baseline and 3-week (+/- 1 week) the STAI-Y-A scale, which is a 20-item self-questionnaire evaluating anxiety at the present time. The measurement is done on a Likert scale from 1 to 4 (each number corresponding to a value, 1 being the lowest and 4 the highest for each item, score ranging from 20 to 80).
次要结局
- Perinatal depression by EPDS(At 3 time points: 2 in the prenatal period (at baseline and 3 weeks after) and 1 in the postnatal period ( at 4 to 6 weeks postpartum))
- postnatal bonding by PPBQ(at 4 to 6 weeks postpartum)
- Labor agentry by LAS ( Labor Agentry Scale)(at one point at 1day to 7 days postpartum)
- Perinatal bonding by PAI(At one point at baseline)
- Childbirth experience by QEVA(At 1 day to 7 days postpartum)
- Pregnancy related anxiety by PSAS(At 4 time points: 2 in the prenatal period (at baseline and 3 weeks after) and 2 in the postnatal period (at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum))
- State anxiety by STAI-Y-A(between the baseline measurement and the postnatal measurements ( at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum))
- Pregnancy related anxiety by PRAQ-R2(1 time at baseline)
- Pain Visual Analog Scale by EVA(At 2 time points in the postnatal period : at 1 day to 7 days postpartum and at 4 to 6 weeks postpartum)