CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
NCT Number: NCT01566058
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Nîmes, 30029, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The BB Box video system is provided to the mother during the hospitalisation of her premature baby.
The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.
Other names: Standard care
Time frame: Day 3 post-partum
Score ranging from 0 - 21
Time frame: baseline; day 0
score ranging from 0 to 21
Time frame: Day 1 post partum
score ranging from 0 to 21
Time frame: Day 7 post partum
score ranging from 0 to 21
Time frame: Day of hospital discharge for the baby (expected average of 4 weeks)
score ranging from 0 to 21
Time frame: 6 months post partum
score ranging from 0 to 14
Time frame: 12 months post partum
score ranging from 0 to 14
Time frame: Day of hospital discharge for the baby (expected average of 4 weeks)
Time frame: 6 months post partum
Time frame: 12 months post partum
Time frame: base line to day of hospital discharge for the baby (expected average of 4 weeks)
includes bradycardia < 100/min and O2 saturation < 60%
Centre Hospitalier Universitaire de Nīmes
Other
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
Acronym: BBBox
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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