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Breathing Toy for Pain Relief in Pediatric Venipuncture

NCT07430514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-24

No results posted yet for this study

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.

Conditions

  • Procedural Pain
  • Acute Pain
  • Pediatric Pain

Interventions

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

Sponsors & Collaborators

  • Koç University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430514 on ClinicalTrials.gov