Stress Disorders, Post-TraumaticBBBoxNCT01566058
Impact of the BB Box System on Postpartum Maternal Anxiety, Post Traumatic Stress and Mother-child Relationships
A study testing BB Box available and No BB Box in people with Stress Disorders, Post-Traumatic and Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Anxiety
- What is being tested?
- BB Box available and No BB Box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The secondary objectives of the study are to compare the following between the two arms of the study:
- 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.
- The incidence maternal post traumatic stress disorder at 6 and 12 months.
- The incidence of mother-child relationship disorders at 6 and 12 months.
- Infant vital signs during the hospital stay.
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety
- Being tested
- BB Box available, No BB Box
- Keywords
- Post partum, mother-child relationships
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB Box availableDevice
The BB Box video system is provided to the mother during the hospitalisation of her premature baby.
No BB BoxOther
Also called Standard care
The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BB Box available |
| 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) Receives: Other: No BB Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire HADS
Score ranging from 0 - 21
Measured: Day 3 post-partum
Secondary outcomes (10)
Questionnaire HADS
score ranging from 0 to 21
Measured: baseline; day 0
Questionnaire HADS
score ranging from 0 to 21
Measured: Day 1 post partum
Questionnaire HADS
score ranging from 0 to 21
Measured: Day 7 post partum
Questionnaire HADS
score ranging from 0 to 21
Measured: Day of hospital discharge for the baby (expected average of 4 weeks)
Questionnaire PPQ (post traumatic stress disorder)
score ranging from 0 to 14
Measured: 6 months post partum
Questionnaire PPQ (post traumatic stress disorder)
score ranging from 0 to 14
Measured: 12 months post partum
Massie Campbell scale for mother-child relationships
Measured: Day of hospital discharge for the baby (expected average of 4 weeks)
Massie Campbell scale for mother-child relationships
Measured: 6 months post partum
Massie Campbell scale for mother-child relationships
Measured: 12 months post partum
Number of infant cardiovascular events
includes bradycardia < 100/min and O2 saturation < 60%
Measured: base line to day of hospital discharge for the baby (expected average of 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Benito-Castro, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566058
- Sponsor's protocol ID
- LOCAL/2011/FBC-01
- Other IDs
- 2012-A00327-36
- Acronym
- BBBox
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2012
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01566058
- Acronym / sponsor ID
- BBBox / LOCAL/2011/FBC-01
- Conditions
- Stress Disorders, Post-Traumatic, Anxiety
- Keywords
- Post partum, mother-child relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The incidence maternal post traumatic stress disorder at 6 and 12 months.
- The incidence of mother-child relationship disorders at 6 and 12 months.
- Infant vital signs during the hospital stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With BB Box | Experimental | Device: BB Box availableThe 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 | Other: No BB BoxThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB Box availableThe BB Box video system is provided to the mother during the hospitalisation of her premature baby. | Device | With BB Box |
| No BB BoxAlso: Standard careThe BB Box video system is not provided to the mother during the hospitalisation of her premature baby. | Other | Without BB Box |
Primary outcome
Questionnaire HADS
Time frame: Day 3 post-partum
Score ranging from 0 - 21
10 secondary outcomes
Questionnaire HADS
Time frame: baseline; day 0
Questionnaire HADS
Time frame: Day 1 post partum
Questionnaire HADS
Time frame: Day 7 post partum
Questionnaire HADS
Time frame: Day of hospital discharge for the baby (expected average of 4 weeks)
Questionnaire PPQ (post traumatic stress disorder)
Time frame: 6 months post partum
Questionnaire PPQ (post traumatic stress disorder)
Time frame: 12 months post partum
Massie Campbell scale for mother-child relationships
Time frame: Day of hospital discharge for the baby (expected average of 4 weeks)
Massie Campbell scale for mother-child relationships
Time frame: 6 months post partum
Massie Campbell scale for mother-child relationships
Time frame: 12 months post partum
Number of infant cardiovascular events
Time frame: base line to day of hospital discharge for the baby (expected average of 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Benito-Castro, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BB Box available and No BB Box in people with Stress Disorders, Post-Traumatic and Anxiety, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire HADS (time frame: Day 3 post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.