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Набор скоро начнётся NCT07443735

Pinwheel and Bubble Blowing for Pain and Emotional Responses in Children

Без фазы С лечением Pain and Emotional Responses in Children During Venous Blood Sampling

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: Bubble Blowing Group, Pinwheel Group.
Кому может быть актуально
Состояния в реестре: Pain and Emotional Responses in Children During Venous Blood Sampling. Базовые параметры: 3 лет — 6 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effects of Pinwheel and Bubble Blowing on Pain and Emotional Responses in Children During Venous Blood Sampling

Обзор

Venous blood sampling is one of the most frequently performed invasive procedures in children during diagnostic and treatment processes and may lead to pain, fear, and negative emotional responses. Such negative experiences in childhood may contribute to the development of anxiety toward healthcare services and reduced cooperation with healthcare professionals during treatment. Therefore, the use of non-pharmacological interventions aimed at reducing pain levels and emotional responses during procedures is of great importance in pediatric care. The aim of this study is to determine the effects of pinwheel and bubble blowing techniques applied during venous blood sampling on pain levels and emotional states in children. This study will be conducted as a prospective, randomized controlled trial in the Blood Sampling Unit of the Pediatric Outpatient Clinic of a university hospital located in Edirne. A total of 66 children aged 3-6 years who will undergo venous blood sampling will be included in the study (pinwheel group: 22, bubble blowing group: 22, control group: 22). Study data will be collected using the Child and Family Information Form, the Wong-Baker Faces Pain Rating Scale, and the Children's Emotional Indicators Scale. During venous blood sampling, pinwheel or bubble blowing techniques will be applied to the children in the experimental groups, while routine procedures will be performed for the children in the control group. The collected data will be analyzed using appropriate statistical methods. The results of this study are expected to contribute to the dissemination of evidence-based non-pharmacological practices aimed at reducing pain and emotional stress in pediatric nursing care.

Вмешательства

  • Другое Bubble Blowing Group
    The bubble blowing technique will be applied to randomly selected children during blood collection. Prior to the procedure, parents (mothers) will complete a "Child and Family Information Form," and the children's pain and emotional responses will be recorded by the researcher through observation using the Wong-Baker Pain Scale and the Emotional Indicators Scale (EIS). * During the intervention, children will be shown the bubble blowing technique and their attention will be diverted. Compliance
  • Другое Pinwheel Group
    The pinwheel blowing technique will be applied to randomly selected children during blood collection. Before the procedure, parents (mothers) will fill out a "Child and Family Information Form," and the children's pain and emotional responses will be observed by the researcher using the Wong-Baker Facial Pain Scale and EIS. * The use of the pinwheel will be demonstrated during the intervention, and the children's attention will be diverted. Compliance with the intervention will be monitored thr

Первичные конечные точки

  • Children's Pain Level [Срок оценки: The scale will be administered and recorded by the researcher nurse during the procedure and 1 minute after the procedure is completed.]
Вторичные конечные точки (1)
  • Children's Emotional Status [Срок оценки: The scale will be administered and recorded by the observer nurse immediately before the procedure, during venous blood sampling, and immediately after the procedure.]

Критерии участия

Критерии включения

  • Children aged 3-6 years
  • Willingness to undergo intravenous blood collection
  • Children's ability to apply distraction techniques during blood collection
  • No communication problems in children
  • No mental or neurological disability in the child
  • Venous blood collection performed in a single session
  • Parents and children must be willing to participate in the study

Критерии исключения

  • Children not being between the ages of 3 and 6
  • Absence of intravenous blood collection request
  • Communication problems in children
  • Presence of mental or neurological disability in the child
  • Complaints that disrupt the child's comfort, such as pain, nausea, vomiting, etc., due to other reasons
  • Use of analgesic or sedative medication within 6 hours prior to the study
  • Absence of healthy skin integrity
  • Repeated attempts
  • Unexpected events occurring during blood collection
  • Parents or children not volunteering to participate in the study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07443735 · TUTF-SBF-CE-26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗