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

NCT06650683 | Recruiting

• 2 other identifiers: RCAPHM22_00372022-A02696-37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hirschsprung Disease

Outcome Measures

Primary Outcomes (1)

• Questionnary to evaluate stress on parents

  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).

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• Auto-Questionnary MIB (Mother Infant Bounding) to evaluate the impact of nursing support

  From enrollment to the end of treatment at 6 months

• Self-Questionnary Burden inventory to evaluate the nursery training provided

  From enrollment to the end of treatment at 6 months

Study Arms (2)

With Hospitalisation at Home (HAH)

EXPERIMENTAL

families living in Marseille, whose parents will be able to return home under the supervision of nursery nurses from the pediatric HAH.

Behavioral: Pediatric HAH

Without Hospitalisation at Home (HAH)

NO INTERVENTION

Families living outside Marseille whose parents will have to carry out nursings at home independently, without the help of pediatric HAH.

Interventions

Pediatric HAH BEHAVIORAL

Pediatric HAH nursing support for home nursery care provided by parents as part of their child's disease.

With Hospitalisation at Home (HAH)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

APHM

Marseille, France

RECRUITING

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Melanie Boulanger

CONTACT

+33491381245; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: August 14, 2023
• Primary Completion: August 13, 2025
• Study Completion: February 12, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

FR (1)