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

May 29, 2020 updated by: Poitiers University Hospital

Impact of Daily Videoconference Updates in Neonatal Intensive Care Unit on Parental Stress of Preterm Infants : a Pilot Study

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).

Study Overview

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Poitiers, France
        • Chu de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 preterm infants and their parents (15 in each group)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Videoconference group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of inclusion until the date of discharge, assessed up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of inclusion until the date of discharge, assessed up to 1 month
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.
From the date of inclusion until the date of discharge, assessed up to 1 month
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.
Through study completion, an average of 2 months
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.
Through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Denis Oriot, Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Actual)

August 18, 2018

Study Completion (Actual)

September 7, 2018

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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