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NOT YET RECRUITING
NCT07550062
NA

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

Sponsor: Uludag University

View on ClinicalTrials.gov

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.

Official title: The Effect Of Video Game-Based Breathing Exercise Intervention On Pain, Fear, And Anxiety During Routine Venipuncture In Pediatric Patients: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

7 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-05

Completion Date

2027-05

Last Updated

2026-04-24

Healthy Volunteers

Yes

Interventions

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.

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.