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

NCT01566058 | Completed

• 2 other identifiers: LOCAL/2011/FBC-012012-A00327-36
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Anxiety

Keywords

Post partum; mother-child relationships

Outcome Measures

Primary Outcomes (1)

• Questionnaire HADS

  Score ranging from 0 - 21

  Day 3 post-partum

Secondary Outcomes (10)

• Questionnaire HADS

  baseline; day 0

• Questionnaire HADS

  Day 1 post partum

• Questionnaire HADS

  Day 7 post partum

• Questionnaire HADS

  Day of hospital discharge for the baby (expected average of 4 weeks)

• Questionnaire PPQ (post traumatic stress disorder)

  6 months post partum

Study Arms (2)

With BB Box

EXPERIMENTAL

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

Without BB Box

ACTIVE COMPARATOR

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

Interventions

BB Box available DEVICE

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

With BB Box

No BB Box OTHER

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

Also known as: Standard care

Without BB Box

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient or baby is participating in another study, excepting the studies "OASIS" or "PROM8736"
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fernando Benito-Castro, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

FR (1)