Effect of Game-Based Breathing Exercise on Pain, Fear, and Anxiety in Children During Venipuncture (NCT07550062)
Summary
A randomized controlled trial (NCT07550062) registered on ClinicalTrials.gov will evaluate the effects of a video game-based breathing exercise using the BREATHING+ system on pain, fear, and anxiety levels in children aged 7-12 years undergoing routine venipuncture procedures. The intervention group receives the game-based breathing exercise in addition to standard care, while the control group receives routine venipuncture only. Pain, fear, and anxiety will be assessed at three time points: before, during, and immediately after the procedure using the Visual Analog Scale (VAS), Children's Anxiety Scale-State (CAS-S), and Children's Fear Scale (CFS).
“This randomized controlled study will aim to evaluate the effects of a video game-based breathing exercise intervention on pain, fear, and anxiety levels in children aged 7-12 years undergoing routine venipuncture.”
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What changed
This ClinicalTrials.gov study registration describes a randomized controlled trial protocol evaluating a video game-based breathing exercise intervention (BREATHING+ system) for reducing procedural pain, fear, and anxiety in children during venipuncture. The study will randomly assign participants aged 7-12 years to either an intervention group receiving the game-based breathing exercise plus standard care, or a control group receiving standard care only, with assessments conducted at three time points using validated pediatric pain and anxiety scales.
Healthcare providers and clinical investigators conducting pediatric procedural pain research should note this registration represents a non-pharmacological intervention approach that may inform future clinical practice guidelines for managing venipuncture-related distress in young children.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture
N/A NCT07550062 Kind: NA Apr 24, 2026
Abstract
Venipuncture is one of the most common invasive procedures in children and is often associated with significant pain, fear, and anxiety.This randomized controlled study will aim to evaluate the effects of a video game-based breathing exercise intervention on pain, fear, and anxiety levels in children aged 7-12 years undergoing routine venipuncture. While the intervention group will receive a video game-based breathing exercise using the BREATHING+ system in addition to standard care, the control group will receive routine venipuncture procedures only. The study population will consist of children aged 7-12 years who meet the inclusion criteria and whose parents/legal guardians provide informed consent. Participants will be randomly assigned to intervention and control groups. Pain, fear, and anxiety levels will be assessed at three time points: before the procedure, during the procedure, and immediately after the procedure. Data will be collected using the Visual Analog Scale (VAS), Children's Anxiety Scale-State (CAS-S), and Children's Fear Scale (CFS), along with a structured questionnaire form. All assessments will be conducted at the predefined time points.
Conditions: Non-Pharmacological Interventions, Breathing Exercise, Venipuncture Pain, Pain Management
Interventions: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture), Video Game-Based Breathing Exercise Device
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