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Completed

NCT Number: NCT07326254

Effect of Chewing Different Flavor Gum on Procedural Pain and Fear

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.

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Key information

Conditions

Pain Management Agnosia Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mus State Hospital, Pediatric Blood Collection Unit

Muş, Province, 49000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugared Gum Chewing

Behavioral

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.

Sugar-Free Gum Chewing

Behavioral

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.

Control

Other

No active gum chewing intervention was performed during blood collection

Primary outcomes

  1. Procedural Pain - Visual Analog Scale (VAS)

    Time frame: 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

  2. Procedural Pain - Pen Pain Scale (PPS)

    Time frame: 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.

  3. Procedural Fear - Children's Fear Scale (CFS)

    Time frame: 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

Secondary outcomes

  1. Duration of Crying During Venipuncture

    Time frame: From needle insertion until completion of venipuncture, with crying duration recorded in seconds, assessed for up to 5 minutes.

    Crying duration will be recorded as a behavioral indicator of distress in children during venipuncture in the control, sugared gum, and sugar-free gum groups.

  2. Parent Satisfaction With Child's Blood Collection Experience

    Time frame: Immediately after completion of venipuncture (within 5 minutes).

    Parent satisfaction will be assessed as a Yes/No response to indicate whether the parent was satisfied with their child's experience during the blood collection procedure. Unit of Measure: Yes/No

Sponsors and collaborators

Lead sponsor

Muş Alparslan University

Other

Registry information

Official study title

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

Acronym: Gum-Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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