Determining the Effectiveness of Chewing Gums With Different Flavors in Reducing Procedural Pain and Fear in Children Aged 7 to 12
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Procedural Pain - Visual Analog Scale (VAS)
研究概览
简要总结
Needle-related pain and anxiety present persistent challenges in pediatric clinical procedures. This study aims to investigate the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. A randomized controlled design will be used with 144 children aged 7-12 years to be recruited between November 2024 and January 2025. Participants will be randomly assigned to control, sugared gum, or sugar-free gum groups. Pain and fear will be assessed using the Visual Analog Scale (VAS), Pen Pain Scale (PPS), and Children's Fear Scale (CFS). Crying duration will be recorded as a behavioral indicator. Data will be analyzed using Kruskal-Wallis, chi-square, and Spearman correlation tests with a significance level of p < .05. The study is intended to evaluate whether chewing gum can serve as a simple, low-cost, and non-invasive method to improve comfort and cooperation during pediatric venipuncture procedures.
详细描述
Needle-related procedures such as venipuncture are among the most common sources of pain, anxiety, and fear in pediatric clinical care. Negative experiences during these procedures may reduce cooperation, increase procedural difficulty, and contribute to long-term avoidance of healthcare settings. Identifying simple, low-cost, and non-pharmacological strategies to improve children's comfort during venipuncture is therefore an important clinical priority.
Chewing gum has been proposed as a potential method for modulating pain and anxiety through mechanisms such as distraction, rhythmic oral motor activity, and sensory engagement. Different gum types, including sugared and sugar-free varieties, may influence children's sensory experience differently. However, evidence regarding the use of chewing gum during pediatric procedures remains limited.
This randomized controlled study is designed to examine the effects of chewing sugared and sugar-free gum on pain, anxiety, and fear in children undergoing venipuncture. A total of 144 children aged 7-12 years will be recruited from outpatient clinical units between November 2024 and January 2025. Participants will be randomly assigned to one of three groups: a control group (no gum), a sugared gum group, or a sugar-free gum group. Children in the intervention groups will chew their assigned gum prior to and during venipuncture.
Pain will be measured using the Visual Analog Scale (VAS) and the Pen Pain Scale (PPS). Fear will be assessed using the Children's Fear Scale (CFS). Crying duration will be recorded as a behavioral indicator of distress. Demographic and clinical variables will also be collected to control for potential confounders.
Data will be analyzed using appropriate non-parametric and categorical statistical tests, including the Kruskal-Wallis test, chi-square test, and Spearman correlation analysis, with a predefined significance level of p < .05. The findings of this study are expected to contribute to the growing body of literature on non-pharmacological interventions for pediatric procedural support and may provide evidence for the integration of chewing gum as a practical technique to improve children's comfort and cooperation during venipuncture.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants were randomly assigned to three groups: control (no gum), sugared gum, and sugar-free gum (n = 48 each) . Randomization was performed using sealed opaque envelopes labeled with group codes. Each child selected one envelope in the presence of a parent. The nurse who performed the blood draw and the researcher responsible for data collection were blinded to group allocation. Complete participant blinding was not feasible due to the visible nature of the intervention.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 7-12 years of age
- •Children requiring venous blood sampling
- •Children able to chew gum safely
- •Children who provide assent, with parental, legal guardian consent
排除标准
- •Children with fever
- •Children experiencing acute pain at the time of assessment
- •Children who used analgesic medication within the previous four hours
- •Children with medical conditions contraindicating gum chewing (e.g., jaw disorders)
- •Children with allergy to gum ingredients
- •Children with communication difficulties related to neurodevelopmental, hearing, visual impairments
- •Children currently taking analgesic, sedative medications before the procedure
结局指标
主要结局
Procedural Pain - Visual Analog Scale (VAS)
时间窗: Immediately following the blood collection procedure (within a few minutes)
Pain will be assessed using the Visual Analog Scale (VAS) to measure the severity of procedural pain during venipuncture in children assigned to control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-10). Higher scores indicate worse pain
Procedural Pain - Pen Pain Scale (PPS)
时间窗: Immediately following the blood collection procedure (within a few minutes)
Pain will be assessed using the Pen Pain Scale (PPS) to measure the severity of procedural pain during venipuncture in children assigned to control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-5): Higher scores indicate worse pain.
Procedural Fear - Children's Fear Scale (CFS)
时间窗: Immediately following the blood collection procedure (within a few minutes)
Fear will be assessed using the Children's Fear Scale (CFS) to measure the level of fear experienced by children during venipuncture in control, sugared gum, or sugar-free gum groups. Units on a Scale. Minimum-Maximum Value: (0-4). Higher scores indicate greater fear
次要结局
- Duration of Crying During Venipuncture(From needle insertion until completion of venipuncture, with crying duration recorded in seconds, assessed for up to 5 minutes.)
- Parent Satisfaction With Child's Blood Collection Experience(Immediately after completion of venipuncture (within 5 minutes).)
研究者
Emine Beyaz
Principal Investigator
Muş Alparslan University