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Набор скоро начнётся NCT07731347

Two Different Therapeutic Interventions Applied During Blood Sampling in Children

Без фазы С лечением Blood Sampling Child, Only Pain Fear

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: experimental group, experiment group, Control Group.
Кому может быть актуально
Состояния в реестре: Blood Sampling, Child, Only, Pain, Fear. Базовые параметры: 5 лет — 7 лет · 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Комбинированный продукт experimental group
    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
  • Комбинированный продукт experiment group
    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
  • Комбинированный продукт Control Group
    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)

Первичные конечные точки

  • FLACC Pain Assessment Scale [Срок оценки: through study completion, an average of 1 year]
  • Children's Fear Scale [Срок оценки: through study completion, an average of 1 year]
  • Child Anxiety Scale [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Igdır University — Iğdır

Идентификаторы

NCT: NCT07731347 · Eda4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗