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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Fear
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fear
时间窗: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
The scale was developed for the age group of 4-10 years and is used in studies up to 3 years of age. It consists of five facial expressions ranging from neutral (0 points: no anxiety) to frightened face (4 points: severe anxiety). The child is asked to mark the degree of fear by choosing the most appropriate facial expression. As the score obtained from the scale increases, the child's level of fear increases.
Anxiety
时间窗: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
The scale is in the form of a thermometer. The bottom part of the thermometer is labelled as 'Calm: Not tense or anxious (0 points)', and the top part is rated as "Very tense or anxious (10 points)". To assess the child's state of anxiety, the child is asked to mark how he/she feels 'right now' on the thermometer. As the score obtained from the scale increases, the anxiety level of the child increases.
次要结局
- Pulse Rate(5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment)
- Respiratory Rate(5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment)
- Saturation rate(5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment)
研究者
Ilcim Ercan Koyuncu
Lecturer
Baskent University