Clinical Trials Directory

Trials / Completed

CompletedNCT01566058

Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
59 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEBB Box availableThe BB Box video system is provided to the mother during the hospitalisation of her premature baby.
OTHERNo BB BoxThe BB Box video system is not provided to the mother during the hospitalisation of her premature baby.

Timeline

Start date
2013-01-01
Primary completion
2014-01-01
Completion
2015-04-01
First posted
2012-03-29
Last updated
2015-04-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01566058. Inclusion in this directory is not an endorsement.