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

Not Applicable

Completed

• Conditions: Anxiety; Stress Disorders, Post-Traumatic
• Interventions: Device: BB Box available; Other: No BB Box

• Registration Number: NCT01566058
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Study Start: 2013-01
• Primary Completion: 2014-01
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With BB Box	BB Box available	The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby.
Without BB Box	No 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)

Primary Outcome Measures

Name	Time	Method
Questionnaire HADS	Day 3 post-partum	Score ranging from 0 - 21

Secondary Outcome Measures

Name	Time	Method
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)	includes bradycardia \< 100/min and O2 saturation \< 60%
Questionnaire HADS	Day of hospital discharge for the baby (expected average of 4 weeks)	score ranging from 0 to 21
Questionnaire PPQ (post traumatic stress disorder)	12 months post partum	score ranging from 0 to 14

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France