Intravenous Catheter Application

Официальное название

The Effect of Stress Ball and Watching Cartoons on Pain and Fear During Intravenous Catheter Application in Children: A Randomised Controlled Study

Обзор

The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion. Hypotheses of the Study Hypothesis 1: Children who watch cartoons during intravenous catheter insertion have lower pain and fear scores than the control group. Hypothesis 2: The pain and fear of children who squeeze a stress ball during intravenous catheter insertion are lower than the control group Hypothesis 3: There is a difference between the pain and fear scores of children who watch cartoons and squeeze a stress ball.

Подробное описание

Explain how you determined the number The population of the study will consist of children admitted to the paediatric clinic of a State Hospital between 01 September 2025 and 01 February 2026. While calculating the sample size, the intergroup G\*Power 3.1.9.4 maximum 10% type II error rate (1 - β = 0.90), maximum 5% type I error rate (α = 0.05), two-way hypothesis minimum sample size was determined as 90. It was planned to have 30 children in each group, with a total sample size of 90.

Implementation of Research:

Groups will be formed by computer-aided randomisation. Explanations will be made in accordance with the developmental level before the procedure. In the study, children will be divided into 3 groups as two intervention and one control group. The intervention groups are "Watching Cartoon Film" and "Squeezing Stress Ball". Cartoon Group: Two minutes before the intravenous catheter is inserted, the cartoon film chosen by the child will be started to be watched on the tablet. As a cartoon film, Puzzle Tower or Z Team on TRT Kids channel will be shown to children. Children will be able to watch the cartoon they want. The cartoons will be watched on a 10.2 inch iPad tablet provided by the researcher. Stress Ball Squeezing: Two minutes before the intravenous catheter is inserted, the stress ball will be squeezed. No intervention will be applied to the control group. Pain and fear scores of the child, parent and researcher will be recorded before, during and after the procedure. While the health professional performing the routine intravenous catheter procedure will intervene, the researcher will record the data before, during and after the procedure. The investigators will never perform the intravenous catheter insertion procedure. The researcher will collect relevant data from the child, parent and researcher during intravenous catheter insertion. The data will be recorded by Dr.Hem.Zühal Artuvan, one of the researchers. Consort Flow Diagram of the study is shown in Figure 1.

Вмешательства

• Поведенческое Stress ball
  The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion.
• Поведенческое Cartoons
  The study was a randomised controlled trial showing the effect of watching cartoons and squeezing a stress ball on pain and fear in children admitted for intravenous catheter insertion.

Первичные конечные точки

• Wong-Baker Pain Scale [Срок оценки: 22 weeks]
• Children's Fear Scale [Срок оценки: 22 weeks]

Критерии участия

Критерии включения

• Those who were admitted to Toros State Hospital, Child service on 01 September 2025- 01.02.2026,
• Children aged 6 to 12 years,
• Children scheduled for intravenous catheterisation,
• Children without mental and developmental retardation,
• Children who can speak and understand Turkish,
• Children and parents who signed an informed consent form.

Критерии исключения

• Children who cannot speak or communicate in Turkish,
• Children whose first attempt to insert an intravenous catheter failed,
• Children and parents who did not sign the informed consent form.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07127081 · Toros University

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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