The Effect of Buzzy® and a Stress Ball on Reducing Pain and Fear During Peripheral Intravenous Cannulation in Children

NCT07851909 | Completed

• 1 other identifier: F_Ergezen_YL
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of Buzzy®, a device that applies cold and vibration, and a stress ball on pain and fear during intravenous catheter insertion in children aged 7-12 years. It seeks to answer whether one method is more effective than the other in reducing children's pain and fear during the procedure.

Conditions

Pain; Fear; Pain Management

Outcome Measures

Primary Outcomes (2)

• Fear-Children's Fear Scale (CFS)

  Children's Fear Scale (CFS): Developed by McMurtry and colleagues in 2011 and adapted into Turkish by Özalp Gerçeker and colleagues in 2018, the scale measures children's fear and anxiety. It has five facial expressions scored from 0 (no fear) to 4 (severe fear). In this study, the scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.

  The Children's Fear Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.

• Pain-Wong-Baker FACES Pain Rating Scale

  Wong-Baker FACES Pain Rating Scale: Developed by Donna Wong and Connie Baker in 1981 and revised in 2012, this scale uses six faces to help children rate their pain. Scores range from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain. In this study, children will use the scale to rate their pain during intravenous catheter insertion.

  The Wong-Baker FACES Pain Rating Scale was completed 5 minutes before and 5 minutes after intravenous catheter insertion.

Study Arms (3)

Intervention:Buzzy

EXPERIMENTAL

Behavioral: Buzzy

Intervention:Stress Ball

EXPERIMENTAL

Behavioral: Stress Ball

Control

NO INTERVENTION

Interventions

Buzzy BEHAVIORAL

Before intravenous catheter insertion, the Buzzy® device was placed approximately 5 cm above the insertion site on the child's arm. After 15 seconds of cold and vibration, a research nurse inserted the catheter. The device remained in place until 5 minutes after the procedure and was disinfected before and after each use.

Intervention:Buzzy

Stress Ball BEHAVIORAL

Before intravenous catheter insertion, children were given a stress ball to hold in the hand opposite the insertion site. A few seconds after they began squeezing the ball, the procedure started. Children were asked to continue squeezing and releasing the ball until catheter insertion was complete. The stress ball was disinfected before and after each use.

Intervention:Stress Ball

Eligibility Criteria

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

You may qualify if:

• Children aged 7-12 years
• No chronic illness or intellectual or neurological disability
• No acute pain at hospital admission
• No neurodevelopmental disorder or life-threatening condition, such as sepsis, shock, or respiratory or cardiac arrest
• No analgesic medication within 6 hours before the procedure
• Both the child and parent able to speak and understand Turkish
• No intravenous catheter insertion within the previous year

You may not qualify if:

• Hearing, visual, or cognitive impairment
• Not accompanied by a primary caregiver (mother or father)
• Unconscious upon hospital admission
• More than one attempt required for intravenous catheter insertion in the emergency department

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (7)

• Guillari A, Giordano V, Catone M, Gallucci M, Rea T. Non-pharmacological interventions to reduce procedural needle pain in children (6-12 years): A systematic review. J Pediatr Nurs. 2024 Sep-Oct;78:e102-e116. doi: 10.1016/j.pedn.2024.06.025. Epub 2024 Jul 16.

  PMID: 39013701 RESULT

• Sonmez Duzkaya D, Uysal G, Siktas O, Karakul A, Acikgoz A. Effects of the Helfer skin tap technique and Buzzy(R) application on the levels of pain and fear experienced by children during vaccination: A randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:e278-e284. doi: 10.1016/j.pedn.2024.10.037. Epub 2024 Nov 2.

  PMID: 39489632 RESULT

• Duzkaya DS, Bozkurt G, Ulupinar S, Uysal G, Ucar S, Uysalol M. The Effect of a Cartoon and an Information Video About Intravenous Insertion on Pain and Fear in Children Aged 6 to 12 Years in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2021 Jan;47(1):76-87. doi: 10.1016/j.jen.2020.04.011. Epub 2020 Jul 18.

  PMID: 32690314 RESULT

• Cho YH, Chiang YC, Chu TL, Chang CW, Chang CC, Tsai HM. The Effectiveness of the Buzzy Device for Pain Relief in Children During Intravenous Injection: Quasirandomized Study. JMIR Pediatr Parent. 2022 Apr 29;5(2):e15757. doi: 10.2196/15757.

  PMID: 35486419 RESULT

• Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.

  PMID: 30829735 RESULT

• Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.

  PMID: 27112434 RESULT

• Ali S, Manaloor R, Ma K, Sivakumar M, Beran T, Scott SD, Vandermeer B, Beirnes N, Graham TAD, Curtis S, Jou H, Hartling L. A randomized trial of robot-based distraction to reduce children's distress and pain during intravenous insertion in the emergency department. CJEM. 2021 Jan;23(1):85-93. doi: 10.1007/s43678-020-00023-5. Epub 2020 Dec 10.

  PMID: 33683608 RESULT

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)