Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients

Официальное название

The Effect of Hand Puppet and Squeeze Toy Techniques on Fear, Emotional Expression, and Procedure Success During Peripheral IV Catheter Placement in Pediatric Hematology-Oncology Patients: A Randomized Controlled Trial

Обзор

This randomized controlled trial investigates hand puppet and squeeze toy techniques to reduce fear, emotional distress, and procedure time, and improve IV catheter placement success in 90 pediatric hematology-oncology patients (ages 6-10). Participants will be randomized into three groups: hand puppet, squeeze toy, or control. Outcomes include fear, emotional expression, procedure duration, number of attempts, and first-attempt success.

Вмешательства

• Другое Performing a Hand Puppet to Music
  Children interact with a hand puppet chosen according to their preference during IV catheter placement. The puppet's playful movements and music aim to distract and reduce fear and emotional distress.
• Другое Hand Squeezing Soft Toy (Squishy)
  Children will receive a soft, colorful squeeze toy in their non-procedure hand during IV catheter placement. They will be encouraged to rhythmically squeeze and release the toy, which engages their attention, reduces fear and distress, and helps them keep the procedure hand still. The toy is chosen by the child, hygienically managed, and given as a gift afterward. This simple, low-cost intervention aims to improve cooperation and IV placement success.

Первичные конечные точки

• Procedure duration [Срок оценки: During procedure]
• Number of IV catheter attempts: [Срок оценки: During the IV procedure]

Вторичные конечные точки (2)

• Children's Fear Scale [Срок оценки: Measured before and immediately after IV catheter placement]
• Children's Emotional Manifestation Scale [Срок оценки: During procedure]

Критерии участия

Критерии включения

Children aged 6-10 years with a pediatric hematology or oncology diagnosis.

Cognitively able to understand instructions during the procedure.

Require peripheral IV catheter placement as determined by the healthcare team.

Difficult Intravenous Access (DIVA) Score ≥4.

Child and parent/guardian willing to participate.

Критерии исключения

Physical condition preventing use of a squeeze toy.

Cognitive or developmental disorders preventing understanding of procedural instructions.

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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.

Публикации

• Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2. PMID 39002409
• Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17. PMID 39293201

Идентификаторы

NCT: NCT07493018 · AkdenizUnOncology

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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