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EFFECTS OF TWO PAİN MANAGEMENT EDUCATİON METHODS DURİNG HEEL PRİCK PROCEDURES ON MATERNAL ANXİETY AND NEONATAL PAİN

16 de junho de 2026 atualizado por: Sinem Öztürkler, Kocaeli University

THE EFFECT OF TWO DİFFERENT PAİN MANAGEMENT EDUCATİON METHODS PROVİDED FOR HEEL PRİCK PROCEDURES ON MOTHERS' USE OF NONPHARMACOLOGİCAL METHODS, ANXİETY LEVELS, AND NEONATAL PAİN

The aim of this research is to evaluate the effects of two different methods of education (verbal instruction + written brochure and verbal instruction + AI-assisted video presentation) given to new mothers on neonatal pain management, their use of non-pharmacological methods, anxiety levels, and neonatal pain, and to examine the relationship between them.

Research Questions Do two different pain management education methods affect mothers' use of nonpharmacological methods? Do two different pain management education methods affect mothers' anxiety levels? Do two different pain management education methods affect neonatal pain during heel prick procedures? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of mothers' use of nonpharmacological methods? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of maternal anxiety levels? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of neonatal pain during heel prick procedures? Is there a relationship between mothers' use of nonpharmacological methods and their anxiety levels? Is there a relationship between mothers' use of nonpharmacological methods and neonatal pain levels?

Visão geral do estudo

Descrição detalhada

The International Association for the Study of Pain has defined pain as "an unpleasant sensory and emotional experience associated with actual or potential injury" (IASP, 1979). However, it has been noted that this definition is insufficient in newborns, who lack verbal communication, as they cannot express pain and have no opportunity to refuse treatment (Anand & Craig 1996), and later, pain was redefined as an unpleasant sensory and emotional experience associated with or similar to actual or potential tissue damage (Raja et al. 2020). Newborns are frequently exposed to painful procedures during diagnostic and therapeutic processes such as routine newborn screenings, blood glucose measurement, and immunization (WHO, 2017). It has been reported that painful interventions experienced in early childhood can lead to short-term physiological changes as well as neurodevelopmental consequences (AAP 2016; Hatfield & Ely, 2015). Furthermore, it has been shown that exposure to painful stimuli in early life may be associated with stress responses and behavioral changes later in life (Taddio et al. 1997). The first step in pain management is the accurate assessment of pain. Therefore, it is important to use validated scales in the assessment of pain in newborns and to apply appropriate pain management methods (Costa et al. 2017; Rocha et al. 2021). Although pharmacological methods are frequently used in pain management in infants, interest in non-pharmacological methods has increased in recent years due to the physiological immaturity of newborns and possible side effects of drugs (Allegaert and van den Anker, 2017). Methods such as holding, non-nutritive sucking, breastfeeding, sucrose/glucose solutions, skin-to-skin contact, and swaddling are reported to be effective in reducing pain scores during short-term painful procedures (Mangat et al. 2018). The American Academy of Pediatrics recommends that families be actively involved in the prevention and management of pain in newborns (American Academy of Pediatrics, 2016). Within the framework of the family-centered care approach, parental participation in the care of their babies is encouraged, and it is reported that the education given to parents increases the use of pain management methods (Taddio et al. 2013; Campbell-Yeo et al. 2017; Chambers et al. 2020). However, studies that evaluate the effects of different education methods given to mothers during heel prick blood sampling, one of the frequently performed painful procedures in newborns, on mothers' anxiety levels, non-pharmacological method use, and newborn pain are limited. Therefore, this study aimed to determine mothers' approaches to pain management during heel prick blood sampling performed within the scope of newborn screening and to evaluate the effects of two different education methods given before the procedure on mothers' use of non-pharmacological methods, anxiety levels, and newborn pain.

Tipo de estudo

Intervencional

Inscrição (Real)

75

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

    • İ̇zmi̇t
      • Kocaeli, İ̇zmi̇t, Turquia (Türkiye)
        • Kocaeli University

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

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

Being 19 years of age or older Being a primiparous mother Voluntarily agreeing to participate in the study Not having a psychiatric diagnosis Having a healthy term newborn baby (born at 38-42 gestational weeks) Having a blood sample taken for the Guthrie screening test

Exclusion Criteria:

Lack of Turkish reading and comprehension skills in the participant Incomplete completion of the survey form Having a baby with a congenital anomaly Having received any analgesia before the procedure Refusal to have a blood sample taken for the Guthrie screening test History of the baby staying in intensive care

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: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control Group
The mothers underwent the clinic's routine procedure.
Experimental: verbal and brochure-based education
Mothers were given training on non-pharmacological pain management through verbal and brochure education.
Non-pharmacological pain management methods for newborns were explained to mothers verbally and through brochures during heel prick blood tests.
Experimental: verbal and AI-assisted video training
Mothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training.
Non-pharmacological pain management methods for newborns were explained to mothers through verbal and AI-supported video training during heel prick blood sampling.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
mothers' anxiety
Prazo: between 24 and 72 hours after birth
Those scoring between 20 and 80 points indicate anxiety.
between 24 and 72 hours after birth

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Newborn Pain Scale (NIPS)
Prazo: between 24 and 72 hours after birth
The scale consists of six parameters: facial expression, crying, breathing, arm movements, leg movements, and sleep-wake status.
between 24 and 72 hours after birth

Colaboradores e Investigadores

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

Patrocinador

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)

1 de fevereiro de 2025

Conclusão Primária (Real)

1 de abril de 2026

Conclusão do estudo (Real)

1 de maio de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2024/256

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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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