Effect of Chewing Different Flavor Gum on Procedural Pain and Fear

NCT07326254 | Completed

• 1 other identifier: MusAl
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pain management; chewing gum; pediatric nursing; venipuncture; anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Duration of Crying During Venipuncture

  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

  Immediately after completion of venipuncture (within 5 minutes).

Study Arms (3)

Sugared Gum

EXPERIMENTAL

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

Behavioral: Sugared Gum Chewing

Sugar-Free Gum

EXPERIMENTAL

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

Behavioral: Sugar-Free Gum Chewing

Control

PLACEBO COMPARATOR

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

Interventions

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.

Sugared Gum

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.

Sugar-Free Gum

Control OTHER

No active gum chewing intervention was performed during blood collection

Control

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Mus State Hospital, Pediatric Blood Collection Unit

Muş, Province, 49000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  RESULT

Related Links

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

MeSH Terms

Conditions

Agnosia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants were randomly assigned to three groups: control (no gum), sugared gum, and sugar-free gum (n = 48 each) . Randomization was performed using sealed opaque envelopes labeled with group codes. Each child selected one envelope in the presence of a parent. The nurse who performed the blood draw and the researcher responsible for data collection were blinded to group allocation. Complete participant blinding was not feasible due to the visible nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 8, 2026
• Study Start: November 20, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)