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Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward

17. července 2026 aktualizováno: Mervi Hakala

Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward: A Mixed Methods Feasibility Study

Neonatal jaundice is a common condition among newborns and may require phototherapy during the early postnatal period. Although phototherapy is an effective treatment for hyperbilirubinemia, it may be associated with maternal stress, anxiety, concern and disruption of closeness between the mother and newborn. This mixed methods feasibility study evaluates a mothers' heartbeat intervention designed to support maternal well-being and newborn comfort during phototherapy in a maternity ward setting.

The intervention uses a multisensory sleep pad placed under the newborn's mattress during phototherapy. At the beginning of the intervention, each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel these individually recorded maternal sounds and vibrations while lying on the mattress. The intervention is intended to provide womb-like auditory and tactile stimulation and to promote calmness, comfort and a sense of closeness during treatment.

The study includes mothers whose term newborns require phototherapy for jaundice at a maternity ward in Finland. A total of 40 mothers and newborns are included: 20 in the intervention group and 20 in the control group. Data are collected before and after phototherapy. Maternal outcomes include anxiety, stress and experience of phototherapy. The feasibility, usability and acceptability of the intervention are assessed among mothers in the intervention group. In addition, semi-structured interviews are conducted to explore mothers' experiences of successful factors related to the intervention.

The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is acceptable, usable and feasible in a maternity ward during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. The findings will be used to inform the planning of a future larger randomized controlled trial.

Přehled studie

Postavení

Dokončeno

Detailní popis

Neonatal jaundice is one of the most common conditions requiring treatment during the early postnatal period. Phototherapy is an effective and widely used treatment for neonatal hyperbilirubinemia, but the treatment situation may be stressful for mothers. During phototherapy, the newborn may need to remain under phototherapy lights or on a phototherapy blanket for prolonged periods, which may limit normal closeness, skin-to-skin contact and uninterrupted interaction between the mother and newborn. Mothers may experience stress, anxiety, concern and uncertainty related to their newborn's condition, treatment procedures and the need to maintain effective phototherapy exposure.

This mixed methods feasibility study evaluates a mothers' heartbeat intervention during newborn phototherapy in a maternity ward setting. The intervention is designed to provide individually recorded maternal auditory and tactile stimulation to the newborn during phototherapy and to support maternal well-being, newborn comfort and maternal-newborn closeness. The intervention uses a multisensory sleep pad placed under the newborn's mattress. At the beginning of the intervention, the mother's heartbeat, breathing sounds and chest vibrations are recorded. These individually recorded maternal sounds and vibrations are transferred to the sleep pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress.

The intervention is intended to create womb-like auditory and tactile stimulation and to provide a familiar maternal sensory environment during treatment. The newborn receives usual phototherapy care according to standard clinical practice, and the mothers' heartbeat intervention is used as an additional supportive intervention. The newborn remains in phototherapy as much as possible to achieve the intended treatment effect, and usual care activities such as feeding, diaper changing and drying are carried out according to normal maternity ward routines.

The study is conducted as a mixed methods feasibility study with a quasi-experimental pilot design and qualitative interviews. A total of 40 mothers and their term newborns requiring phototherapy for jaundice are included. The intervention group includes 20 mothers and newborns who receive the mothers' heartbeat intervention in addition to usual phototherapy care. The control group includes 20 mothers and newborns who receive usual phototherapy care only. Data are collected in two consecutive periods from June 2024 to January 2025 in a university hospital maternity ward in Finland.

The study population consists of mothers whose newborns are born at 37+0 to 41+6 gestational weeks and require phototherapy for jaundice during postnatal care in the maternity ward. Phototherapy is provided in a normal patient room or family room where the mother or parents room-in with the newborn. Phototherapy may be delivered using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need and standard care.

The feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale after phototherapy. Maternal anxiety is measured before and after phototherapy using the State-Trait Anxiety Inventory, state anxiety form. Maternal stress is measured before and after phototherapy using a verbal rating scale for stress. Mothers' experience of phototherapy is assessed after phototherapy using a numerical rating scale. In addition, mothers in the intervention group participate in semi-structured interviews after phototherapy to explore their experiences of the successful factors related to the intervention.

The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is feasible, usable and acceptable in a maternity ward setting during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. Qualitative interview data are used to provide a deeper understanding of how mothers experience the intervention, including its perceived calming effects, user-friendliness and role as a facilitating element during phototherapy.

The findings from this feasibility study will inform the development and planning of a future larger randomized controlled trial. The study may provide preliminary evidence on whether a simple, non-invasive and individually tailored sensory intervention can support mothers and newborns during phototherapy and improve the care experience in maternity ward settings.

Typ studie

Intervenční

Zápis (Aktuální)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Oulu, Finsko, 90220
        • Oulu University Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • The mother has given birth at the study hospital.
  • The mother's newborn requires phototherapy for neonatal jaundice during postnatal care in the maternity ward.
  • The newborn is born at term, between 37+0 and 41+6 gestational weeks.
  • Phototherapy is provided in a normal patient room or family room in the maternity ward where the mother or parents room-in with the newborn.
  • The mother is able to understand Finnish.
  • The mother is able to provide informed consent.
  • The mother is willing to participate in the study.

Exclusion Criteria:

Mothers are excluded if any of the following criteria apply:

  • Sensory impairment affecting participation, including significant visual or hearing impairment.
  • Inability to understand Finnish.
  • Postpartum complications requiring special attention or care, including pre-eclampsia, complicated infection or spinal headache.

Newborns are excluded if any of the following criteria apply:

  • Phototherapy is started within 24 hours after birth.
  • Phototherapy is started at night.
  • The newborn receives home phototherapy.
  • The newborn is born before 37+0 gestational weeks or after 41+6 gestational weeks.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Mothers' Heartbeat Intervention
Participants in this arm receive the mothers' heartbeat intervention in addition to usual phototherapy care. The intervention uses a multisensory Nucu Pad placed under the newborn's mattress. Each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress.
The mothers' heartbeat intervention consists of individually recorded maternal heartbeat, breathing sounds and chest vibrations delivered to the newborn through a multisensory Nucu Pad placed under the mattress during phototherapy. The intervention is used in addition to usual phototherapy care.
Žádný zásah: Usual Phototherapy care
Participants in this arm receive usual phototherapy care only according to standard maternity ward practice. Phototherapy may be provided using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility, usability and acceptability of the mothers' heartbeat intervention
Časové okno: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale (SUS). The SUS includes 10 items rated on a 5-point Likert scale from "strongly disagree" to "strongly agree". The total SUS score ranges from 0 to 100, with higher scores indicating better usability and acceptability.
After completion of phototherapy, approximately 24 hours after the start of phototherapy

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maternal anxiety
Časové okno: Baseline -Before phototherapy
Maternal anxiety is assessed using the State-Trait Anxiety Inventory, state anxiety form (STAI-Y1). The measure includes 20 items assessing the mother's current anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety. Anxiety is classified as low, moderate or high according to the total score.
Baseline -Before phototherapy
Maternal stress
Časové okno: Baseline -Before phototherapy
Maternal stress is assessed using a verbal rating scale for stress (VRSS). Mothers rate their stress on a 0-5 scale ranging from "I did not feel any stress at all" to "I felt the worst stress I can think of". Higher scores indicate higher perceived stress.
Baseline -Before phototherapy
Maternal experience of phototherapy
Časové okno: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Mothers evaluate their overall experience of newborn phototherapy using a numerical rating scale (NRS) from 0 to 10, where 0 indicates a very negative experience and 10 indicates a very positive experience. Higher scores indicate a more positive phototherapy experience.
After completion of phototherapy, approximately 24 hours after the start of phototherapy
Maternal anxiety
Časové okno: After completion of phototherapy, approximately 24 hours after the start of phototherapy.
Maternal anxiety is assessed using the State-Trait Anxiety Inventory, state anxiety form (STAI-Y1). The measure includes 20 items assessing the mother's current anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety. Anxiety is classified as low, moderate or high according to the total score.
After completion of phototherapy, approximately 24 hours after the start of phototherapy.
Maternal stress
Časové okno: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Maternal stress is assessed using a verbal rating scale for stress (VRSS). Mothers rate their stress on a 0-5 scale ranging from "I did not feel any stress at all" to "I felt the worst stress I can think of". Higher scores indicate higher perceived stress.
After completion of phototherapy, approximately 24 hours after the start of phototherapy

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mothers' experiences of successful factors related to the intervention
Časové okno: After completion of phototherapy, approximately 24 hours after the start of phototherapy
Mothers in the intervention group participate in semi-structured interviews after newborn phototherapy. The interviews explore mothers' experiences of successful factors related to the mothers' heartbeat intervention, including perceived calming effects, user-friendliness and the role of the intervention as a facilitating element during phototherapy.
After completion of phototherapy, approximately 24 hours after the start of phototherapy

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Ředitel studie: Tarja Pölkki, Professor, University of Oulu

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. července 2024

Primární dokončení (Aktuální)

30. ledna 2025

Dokončení studie (Aktuální)

30. ledna 2025

Termíny zápisu do studia

První předloženo

13. července 2026

První předloženo, které splnilo kritéria kontroly kvality

17. července 2026

První zveřejněno (Aktuální)

20. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • EETTMK: 12/2024
  • 181/2024 (Identifikátor registru: Pohteen tutkimusdiaarinumero)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared because the study includes a small sample of mothers and newborns and contains sensitive maternal and neonatal health-related data. The qualitative interview data may include contextual information that could increase the risk of participant identification, even after anonymization.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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