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

Anxiety Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566058
• Other study ID #: LOCAL/2011/FBC-01
• Secondary ID: 2012-A00327-36
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: April 29, 2015
• Start date: January 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• BB Box available
The BB Box video system is provided to the mother during the hospitalisation of her premature baby.

Other:
• No BB Box
The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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