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

NCT ID: NCT01566058

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-04-30

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.

Conditions

Stress Disorders, Post-Traumatic; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BB Box available

Intervention Type: DEVICE

The BB Box video system is provided to the mother during the hospitalisation of her premature baby.

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)

Group Type: ACTIVE_COMPARATOR

No BB Box

Intervention Type: OTHER

The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.

Interventions

BB Box available

The BB Box video system is provided to the mother during the hospitalisation of her premature baby.

Intervention Type: DEVICE

No BB Box

The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.

Intervention Type: OTHER

Other Intervention Names

Standard care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Benito-Castro, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2012-A00327-36

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/FBC-01

Identifier Type: -

Identifier Source: org_study_id