NCT07430514

Breathing Toy for Pain Relief in Pediatric Venipuncture

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Koç University · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Procedural Pain
• Acute Pain
• Pediatric Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)