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

NCT07550062 | Not Yet Recruiting

• 1 other identifier: GAMEBREATH-2026/AAKKAYAGUL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pediatric venipuncture; Pain management; Breathing exercise; Non-pharmacological intervention

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale (VAS)

  It consists of a 10 cm long straight line. The point "0" indicates "no pain" and the point "10" indicates "unbearable pain". It can be used in children aged 7 years and older. The child is asked to mark the point that represents the severity of their pain. It has been stated that this scale is more sensitive and reliable than other unidimensional scales. The VAS has been found to be a reliable scale in the evaluation of acute pain.

  1 minute before the intervention, during the intervention, and immediately after the intervention

• Children's Anxiety Scale-State (CAS-S)

  The Children's Anxiety Scale-State (CAS-S) was adapted into Turkish by Özalp Gerçeker et al. in 2018, and its validity and reliability were established for children aged 4-10 years (validity index: 1.00). This scale will be used to assess children's state anxiety during venipuncture. It consists of a thermometer-like visual format in which children indicate their anxiety level by marking a point on the scale. Children who are not cognitively appropriate will be excluded from the assessment. Scores range from 0 to 10, evaluated in 0.5-point increments and rounded to the nearest whole number.

  1 minute before the intervention, and immediately after the intervention

• Child Fear Scale (CFS)

  The Children's Anxiety Scale is used to assess the child's level of anxiety. It is a single-item scale consisting of five gender-neutral facial expressions ranging from a neutral face (0 = no anxiety) to a fearful face (4 = severe anxiety), scored between 0 and 4.

  1 minute before the intervention, during the intervention, and immediately after the intervention

Study Arms (2)

Control Group (Standard Venipuncture Procedure)

NO INTERVENTION

Children in the control group will undergo the standard venipuncture procedure, including an explanation of the procedure and the use of reassuring expressions.

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

EXPERIMENTAL

Children in the intervention group will receive a video game-based breathing exercise in addition to standard venipuncture. The game, selected from the "Breathing Games" application based on the child's age and preferences, will be delivered via the BREATHING+ device with an expiratory-sensitive mouthpiece. Children and parents will be briefly instructed on device use. The child will be guided to inhale through the nose and exhale into the mouthpiece. The exercise will be performed for 1 minute, followed by 2 minutes of rest for procedure preparation, then resumed 1 minute before and continued during venipuncture, totaling approximately 3 minutes.

Other: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture); Device: Video Game-Based Breathing Exercise Device

Interventions

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

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

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

Video Game-Based Breathing Exercise Device 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.

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

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being between 7-12 years of age
• Undergoing a venipuncture procedure
• Able to understand and speak Turkish
• Having written informed consent from the parent/legal guardian and age-appropriate verbal assent from the child

You may not qualify if:

• History of epilepsy or recurrent seizures
• Presence of severe congenital chronic disease, congenital anomaly, or behavioral disorder
• Presence of visual or hearing impairment, or cognitive/developmental delay
• Use of psychoactive medications
• Presence of oral, lip, or orofacial anomalies that may interfere with breathing exercises

Sponsors & Collaborators

• Uludag University: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ayşenur AKKAYA GÜL, Assistant Professor

CONTACT

(0216) 910 19 07; aysenurakkaya006@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician performing the data analysis was blinded to the participants' group assignments to prevent bias. No masking was applied; both participants and researchers were aware of the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Children will be randomly assigned to either an intervention group receiving a video game-based breathing exercise in addition to standard care and a control group receiving standard venipuncture procedures only.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share