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Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture

NCT07550062 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-24

No results posted yet for this study

Summary

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

DEVICE

Video Game-Based Breathing Exercise Device

The system consists of a head-mounted headset unit and a mouthpiece sensor that detects expiration. It operates the game through a mouthpiece that senses the child's exhalation via the oral route and does not involve any medication, electrical stimulation, or invasive procedures.

OTHER

Intervention Group (Video Game-Based Breathing Exercise During Venipuncture)

Children in the intervention group will receive a video game-based breathing exercise in addition to standard venipuncture.

Sponsors & Collaborators

  • Uludag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31

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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 NCT07550062 on ClinicalTrials.gov