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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Stress Disorders, Post-Traumatic; Anxiety

Treatments: Device: BB Box available; Other: No BB Box

Study type: Interventional

Funder types: Other

Identifiers

NCT01566058

LOCAL/2011/FBC-01

2012-A00327-36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

With BB Box

Experimental group

Description:

The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby.

Treatment:

Device: BB Box available

Without BB Box

Active Comparator group

Description:

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)

Treatment:

Other: No BB Box