Anxiety Clinical Trial
— BBBoxOfficial 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
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | April 2015 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Questionnaire HADS | Score ranging from 0 - 21 | Day 3 post-partum | No |
Secondary | Questionnaire HADS | score ranging from 0 to 21 | baseline; day 0 | No |
Secondary | Questionnaire HADS | score ranging from 0 to 21 | Day 1 post partum | No |
Secondary | Questionnaire HADS | score ranging from 0 to 21 | Day 7 post partum | No |
Secondary | Questionnaire HADS | score ranging from 0 to 21 | Day of hospital discharge for the baby (expected average of 4 weeks) | No |
Secondary | Questionnaire PPQ (post traumatic stress disorder) | score ranging from 0 to 14 | 6 months post partum | No |
Secondary | Questionnaire PPQ (post traumatic stress disorder) | score ranging from 0 to 14 | 12 months post partum | No |
Secondary | Massie Campbell scale for mother-child relationships | Day of hospital discharge for the baby (expected average of 4 weeks) | No | |
Secondary | Massie Campbell scale for mother-child relationships | 6 months post partum | No | |
Secondary | Massie Campbell scale for mother-child relationships | 12 months post partum | No | |
Secondary | 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) | Yes |
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