Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit

Recruiting

• Conditions: Postnatal Care
• Interventions: Behavioral: Mother-child bond

• Registration Number: NCT06243861
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

The Kangaroo Unit (UK) takes care of newborns requiring special care or monitoring for a pathology whose clinical situation is stable and whose prognosis is favorable. In order to avoid separating mother and child, these units were created with a care pathway somewhere between that requiring hospitalization in a neonatal unit and that of pathology-free newborns in post-natal care. Theoretically, the mother-child bond created in the UK is as good as that created in conventional post-natal care. However, studies show that there are limits to the quality of the bond in the UK. This study aims to assess whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Study Start: 2024-04-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Patient over 18 years of age, hospitalized in a Kangaroo Unit or in a post-natal unit,
• Affiliated to a social security scheme,
• fluent in French
• no objection of participation

Exclusion Criteria

• Patient who :

  • given birth to a child who was stillborn or died at birth
  • difficulty understanding written French
  • psychological incapacity (psychiatric disorder, too great a vulnerability) or physical incapacity (physical/motor disability) to answer questionnaires,

• Patient under court protection, guardianship or curatorship.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
kangaroo unit	Mother-child bond	-
postnatal care	Mother-child bond	-

Primary Outcome Measures

Name	Time	Method
Mother-infant bonding	Up to 3 days after delivery	Mother-infant bonding score from Taylor's Mother to Infant Bonding Scale (MIBS)

Secondary Outcome Measures

Name	Time	Method
Assessment of mothers' state and trait anxiety levels	Up to 3 days after delivery	using Spielberger's STAY form Y1 and Y2: a self-reported questionnaire with 20 items assessed on a 4 points scale
Assessment of perceived parenting competence	Up to 3 days after delivery	using Gibaud-Wallston's Parenting Sense of Competence Scale (PSOC). The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".
Assessment of patients' quality of life	Up to 3 days after delivery	using the McGill Quality of Life Questionnaire (MQOL). consists of 14 items divided into four domains: The Single-Item Scale (SIS), physical symptoms (three items), feelings and thoughts (seven items), and social (three items).

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital Mercy; 🇫🇷 Metz, France