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NCT Number: NCT06650683

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

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

Recruiting

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APHM

Marseille, France

Location status: Recruiting

Location contact

Melanie Boulanger

CONTACT

[email protected]

+33491381245

Melanie Boulanger

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pediatric HAH

Behavioral

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

Primary outcomes

  1. Questionnary to evaluate stress on parents

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Self-Questionnary Burden inventory to evaluate the nursery training provided

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Boulanger

CONTACT

[email protected]

+33491381245

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: HirscHAD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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