"connEcted Caesarean Section": Creating a Virtual Link Between MOthers and Their infanTs to ImprOve Maternal Childbirth experieNce: a PILOT Trial (E-motion-pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Childbirth Experience Questionnaire 2 (CEQ-2)
研究概览
简要总结
One third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related posttraumatic stress disorder (CB-PTSD) is of 4.7% and the prevalence of childbirth-related posttraumatic stress symptoms (CB-PTSS) of 12.3%. Skin-to-skin contact is a protective factor against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always feasible and mothers and infants are often separated. In those cases, there is no validated and available solution to substitute this unique protective factor. Based on the results observed in studies using virtual reality (VR) and head-mounted displays (HMDs) and studies on childbirth experience, we hypothesize that enabling the mother to have a visual and auditory contact with her baby could improve her childbirth experience whilst she and her baby are separated. To facilitate this connection, we will use a 2D 360° camera filming the baby linked securely to a head-mounted device (HMD) that the mother can wear during the end of the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Women aged 18 years old or older
- •Planned or unplanned CS at ≥ 34 weeks gestation
- •Gave birth to a healthy baby according to pediatric evaluation (APGAR score ≥ 7 at 5 minutes)
- •Gave oral consent followed by a written confirmation of consent
- •Skin-to-skin contact is not possible or was prematurely interrupted
- •Speaks French well enough to participate in study assessments
- •Eligibility confirmed by an independent physician for the intervention group
- •Partner gave oral consent to be filmed for the intervention group.
排除标准
- •Has an established intellectual disability or psychotic illness
- •Has photosensitive epilepsy
- •Caesarean section under general anesthesia
结局指标
主要结局
Childbirth Experience Questionnaire 2 (CEQ-2)
时间窗: 1 week after the birth
Standardised questionnaire of childbirth experience. This self-reported questionnaire measures the maternal childbirth experience with four different subscales: own capacity, perceived safety, professional support and participation. There are 19 items rated on a 4 point Likert scale ranging from 1=totally disagree to 4=totally agree and 3 items rated on a VAS from 1 to 100. Rating of negatively worded statements are reversed. Higher scores indicates a better childbirth experience. The minimum value is 1 and the maximum is 4 points.
次要结局
- Satisfaction of the intervention(1 week after the caesarean section)
- Mother-infant bonding(1 week after the caesarean section)
- Satisfaction of the birth(1 week after the caesarean section)
- Perceived Pain Item(At the end of the caesarean section)
- Perceived Stress Item(At the end of the caesarean section)
- Maternal symptoms of anxiety or depression(1 month after the caesarean section)
- Maternal symptoms of PTSD(1 month after the caesarean section)
研究者
Antje Horsch
Associate Professor
Centre Hospitalier Universitaire Vaudois