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Impact of Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants (VISIO-NEONAT)

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ClinicalTrials.gov Identifier: NCT03438071
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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Brief Summary:
The aim of the study is to test the effect of daily videoconference updates between parents of preterm newborns and health care providers which also offer them the possibility of seeing their child on the parental stress in a neonatal intensive care unit (NICU).

Condition or disease Intervention/treatment
Preterm Infants Parent-Child Relations Parental Stress Post Partum Depression Neonatal Intensive Care Units Videoconferencing Other: Videoconferencing

Study Design
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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Daily Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants : a Pilot Study
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : August 18, 2018
Actual Study Completion Date : September 7, 2018

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Control group
Videoconference group Other: Videoconferencing
Daily videoconference updates using Skype between parents of preterm infants hospitalized in NICU and the nurse taking care of their child, lasting 5 to 10 minutes, to check with her for the daily news and then see their child through the camera.


Outcome Measures
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Primary Outcome Measures :
  1. Level of stress of the mothers [ Time Frame: From date of inclusion until the date of discharge, assessed up to 1 month ]
    Mean score of the mothers of preterm infants hospitalized in NICU on the PSS-NICU (Parental Stressor Scale NICU), measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups.


Secondary Outcome Measures :
  1. Level of stress of the fathers [ Time Frame: From date of inclusion until the date of discharge, assessed up to 1 month ]
    Mean score of the fathers of preterm infants hospitalized in NICU on the PSS-NICU, measured once a week during all the last of their child's hospitalization in the unit, in the 2 groups.

  2. Parental stress evolution [ Time Frame: From the date of inclusion until the date of discharge, assessed up to 1 month ]
    Evolution of the PSS-NICU score of both parents between the inclusion in the study and the last evaluation before their child's discharge of the NICU, in the 2 groups.

  3. Post-partum depression rate of the mothers [ Time Frame: Through study completion, an average of 2 months ]
    Score of the mothers of preterm infants hospitalized in NICU on the EPDS (Edinburgh Post-natal Depression Scale), measured at the inclusion, at discharge and a month later, in the 2 groups.

  4. Quality of the relationship between the parents and their child [ Time Frame: Through study completion, an average of 2 months ]
    Mean score of both parents of preterm infants hospitalized in NICU on the PBQ (Post-partum Bonding Questionnaire), measured once a week during all the last of their child's hospitalization in the unit and a month after his discharge, in the 2 groups.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 preterm infants and their parents (15 in each group)
Criteria

Inclusion Criteria:

  • Parents with a preterm child born between 24 weeks and 34 weeks and 6 days of gestational age, hospitalized in our NICU during recrutment period
  • Which agreed participating to the study after having complete information about it and sign a consent.

Exclusion Criteria:

  • Parents with a preterm child with another pathology than prematurity or with a lenght of stay in the NICU less than 7 days
  • Parents refusing to participate to the study
  • Parents not having videoconference equipment or internet access at home
  • Parents not understanding or speaking good enough French.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438071


Locations
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France
CHU DE Poitiers
Poitiers, France
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Denis Oriot Poitiers University Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03438071    
Other Study ID Numbers: VISIO-NEONAT
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Depression, Postpartum
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Puerperal Disorders
Depressive Disorder
Mood Disorders
Mental Disorders