Pilot Study Evaluating the Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and the Establishment of a Mother-child Relationship in the Context of a Premature Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Questionnaire HADS
研究概览
简要总结
The main objective of this study is to compare the degree of maternal anxiety at Day 3 postpartum in mothers who did or did not have access to a video communication system (BB-Box system) from the time of initial separation with their baby.
详细描述
The secondary objectives of the study are to compare the following between the two arms of the study:
A. The degree of postpartum maternal anxiety at day 1, day 7 and at hospital discharge. Anxiety will be compared point by point but also via kinetics.
B. The incidence maternal post traumatic stress disorder at 6 and 12 months.
C. The incidence of mother-child relationship disorders at 6 and 12 months.
D. Infant vital signs during the hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow up
- •The patient has given birth this day to a premature child (< 36 weeks of gestation and/or < 2 kg birthweight)
- •Separation of child and mother since birth
排除标准
- •The patient or baby is participating in another study, excepting the studies "OASIS" or "PROM8736"
- •The patient or baby is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient or father refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Preexisting maternal psychiatric pathology
- •Major or lethal poly-malformation syndrome
- •Severe pathologies that threaten child survival: pulmonary hypertension, septic shock, anoxic-ischemic brain
- •Any emergency situation preventing patient involvement
- •Mother and/or child not hospitalized at the Nîmes University Hospital
- •Death of the patient or child during the study
研究组 & 干预措施
With BB Box
The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby.
干预措施: BB Box available (Device)
Without BB Box
The mothers in this arm of the study will not have access to a "BB Box" video system to maintain contact with their premature baby. (Standard care)
干预措施: No BB Box (Other)
结局指标
主要结局
Questionnaire HADS
时间窗: Day 3 post-partum
Score ranging from 0 - 21
次要结局
- Massie Campbell scale for mother-child relationships(12 months post partum)
- Number of infant cardiovascular events(base line to day of hospital discharge for the baby (expected average of 4 weeks))
- Questionnaire HADS(Day of hospital discharge for the baby (expected average of 4 weeks))
- Questionnaire PPQ (post traumatic stress disorder)(12 months post partum)
- Questionnaire HADS(baseline; day 0)
- Questionnaire HADS(Day 1 post partum)
- Questionnaire HADS(Day 7 post partum)
- Questionnaire PPQ (post traumatic stress disorder)(6 months post partum)
- Massie Campbell scale for mother-child relationships(Day of hospital discharge for the baby (expected average of 4 weeks))
- Massie Campbell scale for mother-child relationships(6 months post partum)