Distraction Methods for Reducing Pain and Fear During Blood Draw in Children

NCT07770191 | Recruiting

• 1 other identifier: KUTMAN-PED-2026-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Parental satisfaction with the care provided during the procedure will also be evaluated. A total of 164 children will be assigned in a 1:1:1:1 ratio to the pinwheel blowing, 3D hologram viewing, gum chewing, or control group using block randomization stratified by age and sex. The interventions will begin one minute before the blood draw and continue until the procedure is completed. Children in the control group will receive the routine blood draw procedure without any additional nonpharmacological intervention. Immediately after the blood draw, the child's pain and fear during the procedure will be independently evaluated by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will also be assessed after the procedure.

Conditions

Pain Management; Fear

Keywords

Distraction; 3D Hologram; Gum Chewing

Outcome Measures

Primary Outcomes (2)

• Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale

  Pain experienced during the blood draw will be assessed by the child using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces scored as 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.

  Immediately after the blood draw, within approximately 5 minutes

• Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale

  Fear experienced during the blood draw will be assessed by the child using the Children's Fear Scale. The scale consists of five facial expressions scored from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear. Higher scores indicate greater fear.

  Immediately after the blood draw, within approximately 5 minutes

Secondary Outcomes (1)

• Parent-Reported Satisfaction With the Blood Draw Procedure

  Immediately after the blood draw, within approximately 5 minutes

Study Arms (4)

3D Hologram Viewing Group

EXPERIMENTAL

Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The intervention will begin one minute before the blood draw and continue until the procedure is completed.

Behavioral: 3D Hologram Viewing

Pinwheel Blowing Group

EXPERIMENTAL

Children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed.

Behavioral: Pinwheel Blowing

Gum Chewing Group

EXPERIMENTAL

Children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue until the procedure is completed.

Behavioral: Gum Chewing

Control Group

NO INTERVENTION

Children will receive the routine blood draw procedure used in the pediatric phlebotomy unit. No additional pharmacological or nonpharmacological pain-relieving intervention will be provided. The accompanying parent will remain with the child and may talk to and maintain eye contact with the child during the procedure.

Interventions

3D Hologram Viewing BEHAVIORAL

Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The holographic display will be positioned approximately 50 cm from the child. The intervention will begin one minute before the blood draw and continue until the procedure is completed.

3D Hologram Viewing Group

Pinwheel Blowing BEHAVIORAL

Children blow a colorful handheld pinwheel with a diameter of 16 cm. The intervention begins one minute before the blood draw and continues until the procedure is completed. Children hold the pinwheel with the hand not used for blood collection; the researcher holds it when necessary.

Pinwheel Blowing Group

Gum Chewing BEHAVIORAL

Children will select a 14.5-g piece of sugar-free flavored gum and begin chewing it one minute before the blood draw. The available flavors will include watermelon, strawberry, orange, and mixed fruit. Children will continue chewing the gum until the procedure is completed.

Gum Chewing Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5 to 10 years
• Scheduled to undergo a blood draw
• No analgesic medication use within 6 hours before the procedure
• No visual, hearing, or speech impairment
• No neurological disorder
• No oral or jaw condition that may prevent gum chewing
• No chronic illness requiring frequent invasive procedures
• Written informed consent provided by the parent or legal guardian
• Verbal assent provided by the children

You may not qualify if:

• Previous history of syncope during blood draw procedures
• Blood draw not completed on the first attempt
• Development of syncope during the procedure
• Inability or unwillingness to complete the assigned intervention
• Withdrawal of consent or assent by the parent or child at any stage of the study

Sponsors & Collaborators

• Gülsev Kutman: lead
• Tekirdağ City Hospital: collaborator

Study Sites (1)

Tekirdağ City Hospital

Tekirdağ, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gülsev Kutman

  Tekirdağ City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülsev Kutman, Rn Msc

CONTACT

0905521392671; glsvktmn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was not possible because the interventions were directly visible to the participants, parents, researcher, phlebotomy nurse, and observer nurse.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Pediatric Nurse

Model Details: Participants are assigned to one of four parallel study groups: 3D hologram viewing, pinwheel blowing, gum chewing, or control.

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 18, 2026
• Study Start: June 15, 2026
• Primary Completion: September 15, 2026
• Study Completion: September 15, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)