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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01566058
First received: March 27, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stress Disorders, Post-Traumatic
Anxiety
Device: BB Box available
Other: No BB Box

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Questionnaire HADS [ Time Frame: Day 3 post-partum ] [ Designated as safety issue: No ]
    Score ranging from 0 - 21


Secondary Outcome Measures:
  • Questionnaire HADS [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
    score ranging from 0 to 21

  • Questionnaire HADS [ Time Frame: Day 1 post partum ] [ Designated as safety issue: No ]
    score ranging from 0 to 21

  • Questionnaire HADS [ Time Frame: Day 7 post partum ] [ Designated as safety issue: No ]
    score ranging from 0 to 21

  • Questionnaire HADS [ Time Frame: Day of hospital discharge for the baby (expected average of 4 weeks) ] [ Designated as safety issue: No ]
    score ranging from 0 to 21

  • Questionnaire PPQ (post traumatic stress disorder) [ Time Frame: 6 months post partum ] [ Designated as safety issue: No ]
    score ranging from 0 to 14

  • Questionnaire PPQ (post traumatic stress disorder) [ Time Frame: 12 months post partum ] [ Designated as safety issue: No ]
    score ranging from 0 to 14

  • Massie Campbell scale for mother-child relationships [ Time Frame: Day of hospital discharge for the baby (expected average of 4 weeks) ] [ Designated as safety issue: No ]
  • Massie Campbell scale for mother-child relationships [ Time Frame: 6 months post partum ] [ Designated as safety issue: No ]
  • Massie Campbell scale for mother-child relationships [ Time Frame: 12 months post partum ] [ Designated as safety issue: No ]
  • Number of infant cardiovascular events [ Time Frame: base line to day of hospital discharge for the baby (expected average of 4 weeks) ] [ Designated as safety issue: Yes ]
    includes bradycardia < 100/min and O2 saturation < 60%


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Standard care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566058

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Fernando Benito-Castro, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01566058     History of Changes
Other Study ID Numbers: LOCAL/2011/FBC-01, 2012-A00327-36
Study First Received: March 27, 2012
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Post partum
mother-child relationships

Additional relevant MeSH terms:
Anxiety Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014