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Effect of Chewing Different Flavor Gum on Procedural Pain and Fear

NCT07326254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Pain Management

Interventions

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

Sponsors & Collaborators

  • Muş Alparslan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-01-15
Completion
2025-01-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326254 on ClinicalTrials.gov