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

Primary Purpose

Stress Disorders, Post-Traumatic, Anxiety

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BB Box available
No BB Box
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders, Post-Traumatic focused on measuring Post partum, mother-child relationships

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With BB Box

Without BB Box

Arm Description

The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby.

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)

Outcomes

Primary Outcome Measures

Questionnaire HADS
Score ranging from 0 - 21

Secondary Outcome Measures

Questionnaire HADS
score ranging from 0 to 21
Questionnaire HADS
score ranging from 0 to 21
Questionnaire HADS
score ranging from 0 to 21
Questionnaire HADS
score ranging from 0 to 21
Questionnaire PPQ (post traumatic stress disorder)
score ranging from 0 to 14
Questionnaire PPQ (post traumatic stress disorder)
score ranging from 0 to 14
Massie Campbell scale for mother-child relationships
Massie Campbell scale for mother-child relationships
Massie Campbell scale for mother-child relationships
Number of infant cardiovascular events
includes bradycardia < 100/min and O2 saturation < 60%

Full Information

First Posted
March 27, 2012
Last Updated
April 29, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01566058
Brief Title
Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships
Acronym
BBBox
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Anxiety
Keywords
Post partum, mother-child relationships

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With BB Box
Arm Type
Experimental
Arm Description
The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby.
Arm Title
Without BB Box
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
BB Box available
Intervention Description
The BB Box video system is provided to the mother during the hospitalisation of her premature baby.
Intervention Type
Other
Intervention Name(s)
No BB Box
Other Intervention Name(s)
Standard care
Intervention Description
The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.
Primary Outcome Measure Information:
Title
Questionnaire HADS
Description
Score ranging from 0 - 21
Time Frame
Day 3 post-partum
Secondary Outcome Measure Information:
Title
Questionnaire HADS
Description
score ranging from 0 to 21
Time Frame
baseline; day 0
Title
Questionnaire HADS
Description
score ranging from 0 to 21
Time Frame
Day 1 post partum
Title
Questionnaire HADS
Description
score ranging from 0 to 21
Time Frame
Day 7 post partum
Title
Questionnaire HADS
Description
score ranging from 0 to 21
Time Frame
Day of hospital discharge for the baby (expected average of 4 weeks)
Title
Questionnaire PPQ (post traumatic stress disorder)
Description
score ranging from 0 to 14
Time Frame
6 months post partum
Title
Questionnaire PPQ (post traumatic stress disorder)
Description
score ranging from 0 to 14
Time Frame
12 months post partum
Title
Massie Campbell scale for mother-child relationships
Time Frame
Day of hospital discharge for the baby (expected average of 4 weeks)
Title
Massie Campbell scale for mother-child relationships
Time Frame
6 months post partum
Title
Massie Campbell scale for mother-child relationships
Time Frame
12 months post partum
Title
Number of infant cardiovascular events
Description
includes bradycardia < 100/min and O2 saturation < 60%
Time Frame
base line to day of hospital discharge for the baby (expected average of 4 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Benito-Castro, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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