The Effect of the Popit Toy and Stress Ball on Anxiety, Fear, Emotional State, and Satisfaction Levels During Inhaler Medication Administration in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Anxiety levels
研究概览
简要总结
The goal of this clinical trial is to evaluate whether using a popit toy and a stress ball as distraction methods during inhaled medication administration can reduce anxiety, fear, and negative emotional responses and improve satisfaction in children aged 4-6 years receiving treatment in a pediatric emergency unit.
The main questions it aims to answer are:
- Does using a popit toy or a stress ball during inhaled medication administration reduce children's anxiety, fear, and negative emotional responses?
- Does using a popit toy or a stress ball improve children's satisfaction with the procedure?
- Do these distraction methods affect physiological parameters? To determine the effects of these non-pharmacological methods, researchers will compare the Popit toy group, the stress ball group, and the standard control group, which receives no intervention.
Researchers compared a pop-it toy group, a stress ball group, and a control group to determine the effects of these non-pharmacological methods.
Participants:
- Participants were randomly assigned to one of three groups: the pop-it toy group, the stress ball group, or the control group.
- They received inhalation therapy according to the standard treatment protocol.
- Assessments of anxiety, fear, emotional state, and satisfaction were conducted before and/or after the procedure.
- Physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were measured before and after the administration of the inhalation medication.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 6 years.
- •Presentation to the pediatric emergency unit with a respiratory disease requiring inhaled medication (nebulizer or inhaler therapy).
- •Oxygen saturation (SpO₂) of 90% or higher before the procedure.
- •No congenital anomalies.
- •Not crying before the inhaled medication procedure.
- •Parent or legal guardian able to provide written informed consent.
- •Child willing to participate in the study.
排除标准
- •The child being younger than 4 or older than 6 years of age
- •Having communication, cognitive, or neurological issues
研究组 & 干预措施
Popit toy group
Before starting the inhaler administration, the child's attention was diverted by introducing a "Popit" toy. The child was encouraged to play with the Popit for 2 minutes before starting inhaler treatment and to continue playing throughout the procedure.
干预措施: Intervention 1 Popit toy (Behavioral)
Stress ball group
To divert the child's attention before starting the procedure, a stress ball was introduced to the child who was to receive the inhaler treatment. The child was encouraged to play with the stress ball two minutes before starting inhaler treatment, and this activity was continued throughout the procedure
干预措施: Intervention 2 Stress ball (Behavioral)
Control group
No distraction methods were used during the intervention.
结局指标
主要结局
Anxiety levels
时间窗: 1 day
State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.
Fear levels
时间窗: 1 day
Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.
Emotional State levels
时间窗: 1 day
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS). Higher scores indicate more negative emotional responses
次要结局
- Satisfaction levels(1 day)
- The child's heart rate(1 day)
- The child's respiratory rate(1 day)
- The child's Oxygen Saturation (SpO₂)(1 day)
- The child's body temperature(1 day)
研究者
Pınar Dogan
Asst. Prof.
Izmir Katip Celebi University