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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Traumatic
Stress Disorders, Post-Traumatic
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014