Breathing Toy for Pain Relief in Pediatric Venipuncture

NCT07430514 | Completed

• 1 other identifier: KU-NURSING-2018-152
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental: Breathing Toy Distraction

EXPERIMENTAL

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

No Intervention: Standard Care

NO INTERVENTION

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.

Interventions

Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection BEHAVIORAL

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

Experimental: Breathing Toy Distraction

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Zeynep Kamil Maternity and Children's Disease Training and Research Hospital

Istanbul, Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 23957021 RESULT

MeSH Terms

Conditions

Pain, Procedural; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 24, 2026
• Study Start: December 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)