Anxiety, Stress Disorders, Post-Traumatic
Conditions
Keywords
Post partum, mother-child relationships
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.
Interventions
DEVICEBB Box available
The BB Box video system is provided to the mother during the hospitalisation of her premature baby.
OTHERNo BB Box
The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire HADS | Day 3 post-partum | Score ranging from 0 - 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire HADS | baseline; day 0 | score ranging from 0 to 21 |
| Questionnaire PPQ (post traumatic stress disorder) | 6 months post partum | score ranging from 0 to 14 |
| Massie Campbell scale for mother-child relationships | Day of hospital discharge for the baby (expected average of 4 weeks) | — |
| Number of infant cardiovascular events | base line to day of hospital discharge for the baby (expected average of 4 weeks) | includes bradycardia \< 100/min and O2 saturation \< 60% |
Countries
France
Outcome results
None listed