Effect of Buzzy®, Cognitive Behavioral Intervention, and Kaleidoscope During SC Injection in Children With Cancer
Buzzy®, a Cognitive-Behavioral Intervention Package, and a Kaleidoscope for Reducing Pain, Fear, and Anxiety During Subcutaneous Injections in Children With Cancer: A Three-Arm Randomized Controlled Trial
Subcutaneous injections are commonly used in pediatric oncology care and may cause pain, fear, and anxiety in children. Repeated exposure to needle-related procedures may increase procedural distress and affect children's cooperation and coping during treatment. Therefore, simple, safe, and feasible non-pharmacological interventions are needed to improve children's comfort during routine procedures.
This randomized parallel trial was designed to compare three clinically feasible non-pharmacological approaches with different mechanisms during subcutaneous injections in children with cancer. Buzzy® provides cold and vibration as a sensory-based method, the cognitive behavioral intervention package supports preparation and coping, and the kaleidoscope provides visual distraction. By comparing these approaches within the same procedural context, the study aimed to provide practical evidence for pediatric oncology nurses when selecting interventions to reduce procedural distress.
All procedures were conducted in the routine clinical procedure area of a pediatric oncology clinic. The same subcutaneous injection procedure was used for all participants, and standardized assessment time points were applied before and immediately after the procedure.
Обзор исследования
Статус
Подробное описание
This study was conducted as a randomized, parallel-group clinical trial in children with cancer undergoing routine subcutaneous injection. Participants were assigned to one of three intervention groups: Buzzy®, a cognitive-behavioral intervention package, or kaleidoscope distraction.
All interventions were delivered in the same clinical setting and within the same procedural context. Before the injection, baseline levels of procedural fear and state anxiety were assessed. The assigned intervention was then applied according to the group allocation during the subcutaneous injection procedure. Pain, fear, and state anxiety were evaluated immediately after the procedure using standardized pediatric assessment tools.
The trial was designed to compare three non-pharmacological strategies that are practical for use in pediatric oncology nursing care. The purpose was to determine whether sensory stimulation, cognitive-behavioral preparation and coping support, or visual distraction differed in their effects on procedural pain, fear, and anxiety during subcutaneous injection.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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İzmit
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Kocaeli, İzmit, Турция (Туркие), 41001
- Kocaeli University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Children aged 6 to 12 years
- Diagnosis of cancer
- Having received chemotherapy at least once
- Willingness of both the child and parent to participate in the study
Exclusion Criteria:
- Visual, auditory, verbal, or cognitive impairment preventing participation
- Terminal stage of disease
- Use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
- Baseline pain score of 2 or higher on the Wong-Baker Faces Pain Rating Scale unrelated to the procedure
- Inability to complete the injection in a single attempt
- Withdrawal before completion of the study procedures
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Cognitive-Behavioral Intervention Package Group
Children assigned to this group received the cognitive-behavioral intervention package during the subcutaneous injection procedure.
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The Cognitive Behavioral Intervention Package was delivered by the researcher before, during, and after the subcutaneous injection.
Before the procedure, the child received brief age-appropriate preparation, selected a preferred distraction or coping strategy, and the parent was guided on how to support the child.
During the injection, the researcher provided standardized verbal coaching, encouragement, and coping support, while the parent provided physical and verbal comfort.
The child used the selected coping strategy throughout the injection.
After completion of the outcome assessments, brief positive reinforcement was provided.
The intervention was implemented using a structured checklist to support standardization.
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Активный компаратор: Buzzy® Group
Children assigned to this group received the Buzzy® intervention during the subcutaneous injection procedure.
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The Buzzy® device was used as a cold and vibration intervention during subcutaneous injection.
The device was placed at the injection site 60 seconds before needle insertion, and cold and vibration were initiated.
Immediately before needle insertion, the device was repositioned approximately 3 cm proximal to the injection site.
It remained in place throughout the injection and was removed immediately after the procedure was completed.
No additional distraction or cognitive behavioral coaching was provided beyond standard procedural explanations.
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Активный компаратор: Kaleidoscope Group
Children assigned to this group received kaleidoscope distraction during the subcutaneous injection procedure.
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The kaleidoscope was used as a visual distraction intervention during subcutaneous injection.
The child was shown the kaleidoscope shortly before the procedure and was allowed a brief familiarization period.
The kaleidoscope was introduced approximately 1 minute before needle insertion, and the child continued to look through it throughout the injection.
The intervention ended when the injection was completed.
No additional cognitive behavioral coaching or cold/vibration intervention was provided beyond standard procedural explanations.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Post-Procedural Pain Intensity Assessed Using the Wong-Baker FACES Pain Rating Scale
Временное ограничение: Immediately after subcutaneous injection
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Post-procedural pain intensity will be assessed immediately after subcutaneous injection using the Wong-Baker FACES Pain Rating Scale.
This scale ranges from 0 to 5, with 0 indicating no pain and 5 indicating the worst pain.
Higher scores indicate greater pain intensity.
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Immediately after subcutaneous injection
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Procedural Fear Assessed Using the Children's Fear Scale
Временное ограничение: Before and immediately after subcutaneous injection
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Procedural fear will be assessed before and immediately after subcutaneous injection using the Children's Fear Scale.
This scale ranges from 0 to 4, with 0 indicating no fear and 4 indicating extreme fear.
Higher scores indicate greater procedural fear.
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Before and immediately after subcutaneous injection
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State Anxiety Assessed Using the Children's Anxiety Scale-State
Временное ограничение: Before and immediately after subcutaneous injection
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State anxiety related to subcutaneous injection will be assessed before and immediately after the procedure using the Children's Anxiety Scale-State.
This scale ranges from 0 to 10, with 0 indicating no anxiety and 10 indicating the highest level of anxiety.
Higher scores indicate greater state anxiety.
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Before and immediately after subcutaneous injection
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Birgül Erdoğan, PhD, RN, Kocaeli University
Публикации и полезные ссылки
Общие публикации
- Bekar P, Erkul M, Efe E. The effect of using a kaleidoscope during central venous catheter dressing changes on pain and anxiety in children with cancer: A randomised controlled trial. Eur J Oncol Nurs. 2022 Apr;57:102114. doi: 10.1016/j.ejon.2022.102114. Epub 2022 Feb 25.
- Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.
- Erdogan B, Ercelik ZE, Ozdemir AA. Effects of a cognitive-behavioral intervention package on pain, fear, and anxiety during port catheter needle insertion in children with cancer: A randomized controlled trial. J Pediatr Nurs. 2026 May-Jun;88:98-106. doi: 10.1016/j.pedn.2026.02.017. Epub 2026 Feb 20.
- de la Maza V, Fuentes V, Cabrolier E, Fernandez MS, Saez S, Concha C, Nicklas C, Castro M, Torres JP. Efficacy, Safety, and Pain Level of Subcutaneous Catheter Use for Administration of Granulocyte Colony-Stimulating Factor (G-CSF) in Children With Cancer: A Randomized Pilot Study. J Pediatr Hematol Oncol Nurs. 2023 Sep-Oct;40(5):305-312. doi: 10.1177/27527530231190373. Epub 2023 Nov 3.
- McNeil MJ, Garcia Quintero X, Gonzalez M, Zheng Y, Ugaz Olivares C, Morales R, Boldrini E, Rebollo de Campos D, Ferreira D, Coopasamy K, Caneba J, Padernilla ML, Friedrichsdorf S, Baker JN, Friedrich P. Preventing and Treating Pain and Anxiety during Needle-Based Procedures in Children with Cancer in Low- and Middle-Income Countries. Cancers (Basel). 2024 Mar 1;16(5):1025. doi: 10.3390/cancers16051025.
- Loeffen EAH, Mulder RL, Font-Gonzalez A, Leroy PLJM, Dick BD, Taddio A, Ljungman G, Jibb LA, Tutelman PR, Liossi C, Twycross A, Positano K, Knops RR, Wijnen M, van de Wetering MD, Kremer LCM, Dupuis LL, Campbell F, Tissing WJE. Reducing pain and distress related to needle procedures in children with cancer: A clinical practice guideline. Eur J Cancer. 2020 May;131:53-67. doi: 10.1016/j.ejca.2020.02.039. Epub 2020 Apr 14.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SCINJ-PAIN-2025-01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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