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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00327-36 | Other Identifier | RCB number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With BB Box | Experimental | The mothers in this arm of the study will have access to a "BB Box" video system to maintain contact with their premature baby. |
|
| Without BB Box | Active Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BB Box available | Device | The BB Box video system is provided to the mother during the hospitalisation of her premature baby. |
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| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire HADS | Score ranging from 0 - 21 | Day 3 post-partum |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Benito-Castro, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| No BB Box | Other | The BB Box video system is not provided to the mother during the hospitalisation of her premature baby. |
|
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| 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) |