Идёт набор NCT05702203

Creative Music Therapy in Newborns With Congenital Heart Disease

Без фазы С лечением Congenital Heart Disease Mother Child Interaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Creative Music Therapy.
Кому может быть актуально: Состояния в реестре: Congenital Heart Disease, Mother Child Interaction. Базовые параметры: 1 Minute — 28 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial

Обзор

In the context of a clinical trial, the investigators will evaluate if parent-infant interaction can be improved by a family integrated, individualised, interactive resource- and needs-oriented music therapy approach in the dyads of infants with congenital heart disease and their parents. This intervention will be compared with the standard of care. Infants allocated to the control group will receive standard care during admission. Standard care includes involvement of a multi-professional team consisting of medical and nursing team, psychologists/psychiatrists, social workers, breastfeeding counsellor, speech therapist, nutritional counsellor and physiotherapists.

Подробное описание

Open label single-centre randomised controlled interventional trial. All infants with congenital heart disease (CHD) and age \<28 days admitted to the neonatal and paediatric intensive care unit at the University Children's Hospital in Zurich are eligible. Infants will be allocated 1:1 to creative music therapy (CMT) and standard care using block randomization with stratification by socio-economic score (SES, \<8 vs \>8) and risk of CHD according to the Risk Stratification for Congenital Heart Surgery (RACHS-2). CMT will be conducted 3x/week with a minimum of ten sessions. The primary outcome is mother-infant interaction at age 6 months assessed using a video of a feeding interaction at home, coded in a blinded manner with the Parent-Child Early Relational Assessment.

Вмешательства

Другое Creative Music Therapy
Creative Music Therapy 3x20 minutes per week during admission, at least 10 session during admission, after discharge once every other week until 6 months of age.

Первичные конечные точки

Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1) [Срок оценки: at age 6 months]

Вторичные конечные точки (12)

Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS) [Срок оценки: from baseline to six months of age]
Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ) [Срок оценки: from baseline until six months age]
Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure [Срок оценки: from baseline until six months age]
Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention) [Срок оценки: from baseline until six months age]
Parental mental health as assessed by General health (GHQ-12) [Срок оценки: from baseline until six months age]
Parental mental health as assessed by Patient Health Questionnaire [Срок оценки: from baseline until six months age]
Parental mental health as assessed by Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: from baseline until six months age]
Parental mental health as assessed by Spielberger State Anxiety Scale (STAI) [Срок оценки: from baseline until six months age]
Parental mental health as assessed by Perceived Stress SCale (PSS-10) [Срок оценки: from baseline until six months age]
Parental mental health as assessed by Parental stress scale (PSS:NICU) [Срок оценки: from baseline until six months age]
Parental mental health as assessed by Post traumatic diagnostic scale DSM-5 (PDS) [Срок оценки: from baseline until six months age]
Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU) [Срок оценки: baseline and at six months age]

Критерии участия

Критерии включения

All newborn infants with CHD born >35 weeks of gestational and <28 days at diagnosis of CHD irrespective of severity of the heart disease
Admitted to Neonatal Intensiv Care Unit/Pediatric Intensiv Care Unit (NICU/PICU) at the Children's University Hospital
Infants with syndromes and /or confirmed chromosomal abnormalities