NCT07326254

Effect of Chewing Different Flavor Gum on Procedural Pain and Fear

Determining the Effectiveness of Chewing Gums With Different Flavors in Reducing Procedural Pain and Fear in Children Aged 7 to 12

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Muş Alparslan University · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Pain Management

Interventions

Type	Name	Description
BEHAVIORAL	Sugared Gum Chewing	Chewing sugared gum, which began one minute before the procedure, continued until the end of the blood collection. Sugared gum provided a sweet taste stimulus, while sugarless gum served as a non-sweet comparator. Children were continuously monitored to ensure safety and prevent aspiration, and children aged 7-12 were included in the study. No adverse events were reported during the study.
BEHAVIORAL	Sugar-Free Gum Chewing	Participants began chewing sugarless gum one minute before the procedure began, until the blood sample was collected. The purpose of the chewing activity was to reduce pain and fear during the procedure. No other behavioral or pharmacological interventions were administered.
OTHER	Control	No active gum chewing intervention was performed during blood collection

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-01-15
• Completion: 2025-01-30
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Turkey (Türkiye)