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

17 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Oulu, Finlândia, 90220
        • Oulu University Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Feasibility, usability and acceptability of the mothers' heartbeat intervention
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Maternal anxiety
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Mothers' experiences of successful factors related to the intervention
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Diretor de estudo: Tarja Pölkki, Professor, University of Oulu

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de julho de 2024

Conclusão Primária (Real)

30 de janeiro de 2025

Conclusão do estudo (Real)

30 de janeiro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

13 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de julho de 2026

Primeira postagem (Real)

20 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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