Breathing Toy for Pain Relief in Pediatric Venipuncture (BREATHE)

Effect of a Breathing Toy on Pain During Pediatric Venipuncture: A Randomized Controlled Trial

This randomized controlled trial evaluated the effectiveness of a realistic breathing toy distraction intervention on procedural pain, physiological parameters, and parental anxiety during venipuncture in children aged 1-3 years presenting to a pediatric emergency department.

Eighty children were randomly assigned to receive either a breathing toy distraction (experimental group, n=40) or standard care (control group, n=40) during blood collection. The breathing toy is a realistic plush dog that simulates breathing movements with its abdomen rising and falling while producing breathing sounds.

The primary outcome was pain intensity measured by the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale at 1 minute after the procedure. Secondary outcomes included heart rate, oxygen saturation, crying duration, and parental anxiety measured by the Beck Anxiety Inventory.

Results demonstrated significant reductions in pain scores (51% reduction), heart rate elevation, crying duration (72% reduction), and parental anxiety in the experimental group compared to the control group. No adverse events occurred. This simple, cost-effective intervention can be readily integrated into routine pediatric practice with minimal staff training.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Procedural Pain; Pediatric Pain
• Intervention / Treatment: Behavioral: Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection

Detailed Description

BACKGROUND Young children frequently experience acute procedural pain during blood collection in emergency departments. Non-pharmacological interventions, including distraction techniques, are commonly used approaches for procedural pain management. However, evidence regarding the use of breathing simulation toys in toddlers during blood collection procedures is limited. This study aims to evaluate the effect of a breathing simulation toy on procedural pain and physiological parameters in toddlers undergoing blood sampling.

INTERVENTION The breathing toy (Perfect Petzzz brand) is a plush dog (23×9×17 cm) designed to simulate breathing movements through rhythmic abdominal rise and fall accompanied by breathing sounds. The toy complies with international toy safety standards (ASTM F963, CPSIA) and is made of hypoallergenic materials.

In the experimental group, the toy was introduced approximately 5 minutes before the blood collection procedure. The child was positioned on the parent's lap, with the toy placed on the child's lap. The child's hand was gently placed on the toy's abdomen to perceive the simulated breathing movements throughout the procedure. The researcher provided verbal guidance to help maintain the child's attention on the toy.

In the control group, children received standard care without a specific distraction intervention while positioned on the parent's lap. Parental comfort measures were allowed. Environmental conditions were kept consistent between groups.

METHODOLOGY All blood collections were performed by the same pediatric nurse using a 26-gauge butterfly needle from the antecubital vein. Two independent observers blinded to group allocation assessed pain using the FLACC scale. Physiological parameters were measured using a pulse oximeter at baseline (5 minutes before the procedure) and 1 minute after the procedure.

SAFETY For infection control, the toy's abdominal surface was covered with sterile disposable plastic film, which was replaced after each participant.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34668
      • Zeynep Kamil Maternity and Children's Disease Training and Research Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Parent or legal guardian provided written informed consent
• Child aged 1-3 years
• No blood sampling within the previous 6 months
• Healthy children presenting for routine blood tests
• No analgesic medication within 4 hours prior to the procedure
• Child did not display fear of the breathing toy during initial introduction
• Child had intact sensory and neurological function

Exclusion Criteria:

• Chronic illness requiring regular blood sampling
• Known developmental delay or cognitive impairment
• Previous syncopal episode during blood collection
• Visual impairment
• Inability to obtain blood sample on first venipuncture attempt
• Current acute illness requiring hospitalization
• Use of sedatives or anxiolytics within 24 hours prior to procedure
• Parents unable to provide informed consent in Turkish language
• Participation in another clinical trial within 30 days

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Breathing Toy Distraction; Children received a realistic breathing toy (Perfect Petzzz brand) during venipuncture. The toy was introduced 5 minutes before the procedure. The child was positioned on parent's lap with the toy on their lap. The child's hand was placed on the toy's abdomen to feel simulated breathing movements throughout the blood collection procedure. The researcher provided gentle verbal encouragement to maintain attention on the toy.	Behavioral: Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection; A realistic plush breathing toy (Perfect Petzzz brand, 23×9×17 cm) that simulates the breathing pattern of a sleeping dog. The toy's abdomen rises and falls rhythmically while producing soft breathing sounds, creating a multi-sensory distraction experience (visual, tactile, auditory). The toy was introduced to the child and parent approximately 5 minutes before venipuncture to allow familiarization. During the blood collection procedure, the child was positioned on the parent's lap with the toy placed on the child's lap. The researcher gently placed the child's hand on the toy's abdomen so the child could feel the simulated breathing movements. The researcher provided gentle verbal encouragement (e.g., "Feel the puppy breathing") to maintain the child's attention on the toy throughout the procedure. The toy conforms to international toy safety standards
No Intervention: No Intervention: Standard Care; Children received standard care during venipuncture without specific distraction intervention. The child was positioned on parent's lap. Parental comfort measures (holding, talking to child) were permitted. Environmental conditions (lighting, noise, temperature) were maintained constant with the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale	FLACC Pain Scale: The Face, Legs, Activity, Cry, Consolability (FLACC) scale consists of five behavioral indicators, each scored 0-2 (total range 0-10), with higher scores indicating greater pain. The FLACC Scale consists of five behavioral categories, each scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. The Turkish version has established validity and reliability.	1 minute post-procedure
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale	Pain intensity measured using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain assessment scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity. The scale consists of five behavioral indicators (face, legs, activity, cry, consolability), each scored 0-2 points. Two independent observers, blinded to group allocation, assessed FLACC scores.	1 minute post-procedure

Collaborators and Investigators

• Sponsor: Koç University

Publications and helpful links

General Publications

• Gagnon MM, Hadjistavropoulos T, Williams J. Development and mixed-methods evaluation of a pain assessment video training program for long-term care staff. Pain Res Manag. 2013 Nov-Dec;18(6):307-12. doi: 10.1155/2013/659320. Epub 2013 Aug 16.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Acute Pain
• Other Study ID Numbers: KU-NURSING-2018-152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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