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Two Different Therapeutic Interventions Applied During Blood Sampling in Children

3 de setembro de 2026 atualizado por: Eda Gulbetekin, Igdir University

The Effect of Two Different Therapeutic Interventions on Pain, Anxiety and Fear During Venipuncture in Children

This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.

Children participating in the study will be randomly divided into three groups:

  1. Group (Experiment 1): Distraction method using betta fish observation
  2. Group (Experiment 2): Distraction method using hand puppets
  3. Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.

Visão geral do estudo

Descrição detalhada

This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.

Children participating in the study will be randomly divided into three groups:

  1. Group (Experiment 1): Distraction method using betta fish observation
  2. Group (Experiment 2): Distraction method using hand puppets
  3. Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.

The obtained data will be compared using statistical analysis methods. The population of the study will consist of children aged 5-7 years who apply to the Pediatric Emergency Unit of Iğdır Dr. Nevruz Erez State Hospital and undergo venous blood sampling. The sample of the study will consist of children and their parents who meet the inclusion criteria and voluntarily agree to participate in the study. Children selected using an appropriate sampling method will be randomly assigned to three groups.

Tipo de estudo

Intervencional

Inscrição (Estimado)

105

Estágio

  • Fase 1

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.

Contato de estudo

Locais de estudo

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

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Being between 5 and 7 years old,
  • Having a scheduled venous blood sampling procedure in the Pediatric Emergency Unit,
  • Having a level of consciousness suitable for communication,
  • The child and their parents agreeing to participate in the study,
  • Being able to communicate in Turkish.

Exclusion Criteria:

Inability to participate in the application due to visual or hearing problems,

  • Inability to administer the scales due to a developmental or neurological disease,
  • Being under the influence of sedative or analgesic medication,
  • Inability to complete the application during the research process,
  • Lack of parental consent.

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: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental: experimental group

Distraction method using betta fish observation Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.

355 This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling using two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 1 (Experiment 1): Distraction method using betta fish observation

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.

The obtained data will be compared using statistical analysis methods. Group 1 (Experiment 1): Distraction method using betta fish observation

Experimental: Experimental: experimental 2 group
Hand puppet distraction method This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 2 (Experiment 2): Hand puppet distraction method

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.

The obtained data will be compared using statistical analysis methods. Group 2 (Experiment 2): Distraction method using hand puppets

Experimental: Experimental: Experimental: Control Group

Standart of care This research is a carefully planned, three-group, randomized controlled trial to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions.

The working children will be randomly assigned to three groups:

Group 3 (Control): Routine clinical practice (without any therapeutic intervention)

Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.

The obtained data will be compared using statistical analysis methods. Group 3 (Control): Routine clinical practice (without any therapeutic intervention)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
FLACC Pain Assessment Scale
Prazo: through study completion, an average of 1 year
This scale is a pain scale assess pain in children aged 2 months to 7 years.It evaluates leg movements, facial expression, crying, and soothing ability and activity behaviors in relation to the pain experienced by the child. These behaviors are scored using a scale of 0, 1, and 2 points. A score of '0' indicates the absence of pain, '1-3' indicates mild pain, '4-6' indicates moderate pain, and '7-10' indicates the presence of severe pain.
through study completion, an average of 1 year
Children's Fear Scale
Prazo: through study completion, an average of 1 year

The scale is designed for children aged 5 to 10 years. A talented graphic artist developed visual depictions showing changes in facial muscles associated with fear, using photographs of individuals with anxious facial expressions.

The scale can be used by parents, children, or researchers to assess children's fear levels. The child is presented with a scale consisting of five facial expressions, each scored between "0" and "4". A score of "0" indicates a fearless, neutral expression, while "4" represents the highest level of fear. The scores progress as follows: "0" (neutral statement/no fear), "1" (very little fear), "2" (some fear), "3" (more fear) and "4" (highest possible fear). This scale can be used to measure fear both before and during the procedure.

through study completion, an average of 1 year
Child Anxiety Scale
Prazo: through study completion, an average of 1 year
The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years. When the scale is introduced to the child, it is stated that there is no anxiety, that anxiety increases as the scale moves upwards, and that the anxiety level is very high at the top. Then, the child is asked to indicate the level of anxiety or tension they feel with a line. The scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, had its Turkish validity and reliability study conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018). The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years.
through study completion, an average of 1 year

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 agosto de 2026

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2026

Primeira postagem (Real)

28 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

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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