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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress Disorders, Post-Traumatic, Anxiety

Intervention / Treatment
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* Device: BB Box available
* Other: No BB Box


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With BB Box<br>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<br>* The BB Box video system is provided to the mother during the hospitalisation of her premature baby.<br>|
| Active Comparator: Without BB Box<br>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<br>* The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.<br>* Other names: Standard care;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post partum, mother-child relationships