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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Behavioral: Sugared Gum Chewing; Behavioral: Sugar-Free Gum Chewing; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Province
    • Muş, Province, Turkey (Türkiye), 49000
      • Mus State Hospital, Pediatric Blood Collection Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugared Gum; Participants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over.	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.
Experimental: Sugar-Free Gum; Participants start chewing sugared gum one minute before the procedure and continue chewing until the procedure is over.	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.
Placebo Comparator: Control; 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.	Other: Control; No active gum chewing intervention was performed during blood collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Pain - Visual Analog Scale (VAS)	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	Immediately following the blood collection procedure (within a few minutes)
Procedural Pain - Pen Pain Scale (PPS)	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.	Immediately following the blood collection procedure (within a few minutes)
Procedural Fear - Children's Fear Scale (CFS)	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	Immediately following the blood collection procedure (within a few minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Crying During Venipuncture	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.	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	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	Immediately after completion of venipuncture (within 5 minutes).

Collaborators and Investigators

• Sponsor: Muş Alparslan University

Publications and helpful links

General Publications

• Sampallo Pedroza RM, Cardona Lopez LF, Ramirez Gomez KE. Description of oral-motor development from birth to six years of age. Rev Fac Med. 2015;62(4):593-604. Davas S, Kürtüncü M. The effect of three different methods during blood collection on pain level and parental satisfaction in children. Arch Health Sci Res. 2021;8(1):60-68. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17(1):45-56. Beyaz E, Tüfekçi FG. Developing a new one-dimensional scale to measure pain in children: Pencil pain scale. J Pediatr Infants. 2021;4(1):1-10. McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: Preliminary investigation of the Children's Fear Scale. Health Psychol. 2011;30(6):780-788. Gülsoy H, Toru F, Öntürk Akyüz H, Üner FÖ. The impact of kaleidoscope and distraction cards on pain level during blood drawing in children. Med Res Rep. 2024;7(3):120-132.

Helpful Links

• Article on oral-motor development
• Validation of VAS scale
• Distraction methods during pediatric blood draw
• Distraction methods during pediatric blood draw

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 1, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; venipuncture; chewing gum; pain management; pediatric nursing
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Agnosia
• Other Study ID Numbers: MusAl

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be shared in de-identified form upon reasonable request to the Principal Investigator. Data will be available after publication of the main results and will be provided only for research purposes with appropriate ethical approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No