Impact of Providing Nursing Support on Parental Stress Related to Preoperative Care of a Newborn with Hirschsprung's Disease

Not Applicable

Recruiting

• Conditions: Hirschsprung Disease

• Registration Number: NCT06650683
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Impact of providing nursing support on parental stress related to preoperative care of a newborn with Hirschsprung's disease

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-14
• Status Verified: 2024-10
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-08-13
• Study Completion: 2026-02-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Families (one or two parents) with a newborn or infant under 2 months with confirmed or suspected Hirschsprung disease, for whom nursings are effective and performed 1 to 2 times a day while waiting for surgery.
• With a possible return home before surgery
• With an information leaflet and non-opposition form signed by one or both parent(s) or by the legal representative.

Exclusion Criteria

• The absence of daily nursings
• Initial ineffectiveness of nursings requiring a digestive stoma
• Failure to return home before surgery
• Refusal of one or both parent(s) or legal representative(s)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Questionnary to evaluate stress on parents	From enrollment to the end of treatment at 6 months	Evaluation of the impact on parental stress of nursing support by pediatric HAH in nursery care performed at home by parents as part of their child with Hirschsprung using Perinatal Posttraumatic Stress Disorder Questionnaire (PPQ).

Secondary Outcome Measures

Name	Time	Method
Auto-Questionnary MIB (Mother Infant Bounding) to evaluate the impact of nursing support	From enrollment to the end of treatment at 6 months	Estimate the impact of nursing support by pediatric HAH in nursery care performed at home by parents on the development of the parent-child bond, the burden felt by parents in relation to their child's illness, the length of pre-operative hospital stay (initial and re-hospitalization), the pre-operative complications (recurrent occlusion, enterocolitis) and the home nursing care provided by parents (quality of nursings, pace of nursings, difficulties encountered, child's tolerance)
Self-Questionnary Burden inventory to evaluate the nursery training provided	From enrollment to the end of treatment at 6 months	Evaluate nursery training provided by the paramedical team (feedback from parents) : parent training (nursing, understanding illness, understanding illness-related risks) and training aids (sheet, video)

Trial Locations

Locations (1)

APHM; 🇫🇷 Marseille, France