Effect of Chewing Different Flavor Gum on Procedural Pain and Fear (Gum-Pain)

Muş Alparslan University

Status: Completed

Conditions: Pain Management

Treatments: Behavioral: Sugar-Free Gum Chewing; Other: Control; Behavioral: Sugared Gum Chewing

Study type: Interventional

Funder types: Other

Identifiers

NCT07326254

MusAl

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 3 patient groups, including a placebo group

Sugared Gum

Experimental group

Description:

Participants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over.

Treatment:

Behavioral: Sugared Gum Chewing

Sugar-Free Gum

Experimental group

Description:

Participants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over.

Treatment:

Behavioral: Sugar-Free Gum Chewing

Control

Placebo Comparator group

Description:

This group did not receive any gum chewing intervention during the blood collection procedure. Standard procedures were followed. The parent was present with the child during the procedure.

Treatment:

Other: Control