Play Dough and Picture Books: Reducing Anxiety and Fear in 3-6-Year-Olds During Nebulizer Treatment

Официальное название

The Impact of Play Dough and Picture Books on Physiological Parameters, Anxiety, and Fear in 3-6-Year-Old Children During Nebulizer Treatment: a Randomized Controlled Study

Обзор

This randomized controlled trial aims to evaluate the effects of play dough and picture books on physiological parameters, anxiety, and fear levels in children aged 3-6 undergoing nebulizer treatment. The trial will involve two groups: an intervention group engaging with play dough and picture books during treatment and a control group receiving standard care. Physiological data, including heart rate and oxygen saturation, will be monitored alongside behavioral assessments of anxiety and fear. This study seeks to determine whether these non-pharmacological interventions can alleviate distress in young children, contributing to more child-friendly treatment approaches in pediatric healthcare.

Вмешательства

• Другое play dough
  1. Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained. 2. The first part of the Patient Information Form will be completed for children who accept the study. 3. The second part of the Patient Information Form will be completed five minutes before nebulizer treatment. 4. Five minutes before nebulizer treatment, play dough will be given to the child. 5. The child will be allowed to play with the play dough during the nebulize
• Другое picture book reading
  1. Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained. 2. The first part of the Patient Information Form will be completed for children who accept the study. 3. The second part of the Patient Information Form will be completed five minutes before nebulizer treatment. 4. Five minutes before nebulizer treatment, the child will be given a picture book. 5. Picture book will be read to the child during the treatment. 6. The seco

Первичные конечные точки

• Fear [Срок оценки: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment]
• Anxiety [Срок оценки: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment]

Вторичные конечные точки (3)

• Pulse Rate [Срок оценки: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment]
• Respiratory Rate [Срок оценки: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment]
• Saturation rate [Срок оценки: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment]

Критерии участия

Критерии включения

• Being in the 3-6 age group
• Follow-up in the emergency department with upper or lower respiratory tract disease
• Application of nebuliser therapy
• Staying with the parent during the research
• To be able to speak and understand Turkish
• Parents' consent to participate in the study

Критерии исключения

• Having a disease that causes maladaptive behaviours (ADHD, Autism, etc.)
• Having a chronic disease affecting the respiratory tract
• Chronic diseases or serious infections affecting vital signs
• Implementation of droplet or contact isolation
• Having a physical disability that will prevent him/her from playing with playdough
• Having a cognitive disability that prevents reading books

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Başkent University — Ankara

Публикации

• Goralski JL, Davis SD. Breathing easier: addressing the challenges of aerosolizing medications to infants and preschoolers. Respir Med. 2014 Aug;108(8):1069-74. doi: 10.1016/j.rmed.2014.06.004. Epub 2014 Jun 25. PMID 25012949
• Esposito-Festen J, Ijsselstijn H, Hop W, van Vliet F, de Jongste J, Tiddens H. Aerosol therapy by pressured metered-dose inhaler-spacer in sleeping young children: to do or not to do? Chest. 2006 Aug;130(2):487-92. doi: 10.1378/chest.130.2.487. PMID 16899849
• Erzinger S, Schueepp KG, Brooks-Wildhaber J, Devadason SG, Wildhaber JH. Facemasks and aerosol delivery in vivo. J Aerosol Med. 2007;20 Suppl 1:S78-83; discussion S83-4. doi: 10.1089/jam.2007.0572. PMID 17411409
• DiBlasi RM. Clinical Controversies in Aerosol Therapy for Infants and Children. Respir Care. 2015 Jun;60(6):894-914; discussion 914-6. doi: 10.4187/respcare.04137. PMID 26070582
• Supat B, Brennan JJ, Vilke GM, Ishimine P, Hsia RY, Castillo EM. Characterizing pediatric high frequency users of California emergency departments. Am J Emerg Med. 2019 Sep;37(9):1699-1704. doi: 10.1016/j.ajem.2018.12.015. Epub 2018 Dec 12. PMID 30651182
• Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018. PMID 33742204

Идентификаторы

NCT: NCT06668311 · Nebulizer Treatment

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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