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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic; Anxiety
• Intervention / Treatment: Device: BB Box available; Other: No BB Box

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: BB Box available; The BB Box video system is provided to the mother during the hospitalisation of her premature baby.
Active Comparator: 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)	Other: No BB Box; The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.; Other Names: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire HADS	Score ranging from 0 - 21	Day 3 post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire HADS	score ranging from 0 to 21	baseline; day 0
Questionnaire HADS	score ranging from 0 to 21	Day 1 post partum
Questionnaire HADS	score ranging from 0 to 21	Day 7 post partum
Questionnaire HADS	score ranging from 0 to 21	Day of hospital discharge for the baby (expected average of 4 weeks)
Questionnaire PPQ (post traumatic stress disorder)	score ranging from 0 to 14	6 months post partum
Questionnaire PPQ (post traumatic stress disorder)	score ranging from 0 to 14	12 months post partum
Massie Campbell scale for mother-child relationships		Day of hospital discharge for the baby (expected average of 4 weeks)
Massie Campbell scale for mother-child relationships		6 months post partum
Massie Campbell scale for mother-child relationships		12 months post partum
Number of infant cardiovascular events	includes bradycardia < 100/min and O2 saturation < 60%	base line to day of hospital discharge for the baby (expected average of 4 weeks)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Fernando Benito-Castro, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Post partum; mother-child relationships
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Anxiety Disorders; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: LOCAL/2011/FBC-01; 2012-A00327-36 (Other Identifier: RCB number)