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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management; Breathing Exercise; Non-Pharmacological Interventions; Venipuncture Pain
• Intervention / Treatment: Other: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture); Device: Video Game-Based Breathing Exercise Device

Detailed Description

Venipuncture is a common invasive procedure in children and is often associated with pain, fear, and anxiety. Non-pharmacological interventions, particularly distraction and breathing exercises, are recommended to reduce these negative experiences. In this context, this randomized controlled prospective study will 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. The study will be conducted between May 2026 and May 2027 in pediatric blood collection units of hospitals authorized by the Istanbul Provincial Health Directorate. Participants who meet the inclusion criteria and whose parents or legal guardians provide informed consent will be randomly assigned to either an intervention group or a control group. While the intervention group will receive a video game-based breathing exercise using a non-invasive, game-based breathing system in addition to standard care, the control group will receive routine venipuncture procedures only. The system includes a total of 14 different breathing games, such as balloon inflation, candle blowing, and similar activities designed to promote prolonged exhalation. For each child, one game appropriate to their age, developmental level, and preference will be selected, and each game consists of 10 breathing cycles (inhalation and exhalation). The intervention will be implemented using a game selected from a video game-based breathing application according to the child's age, developmental level, interests, and preferences, with expert consultation. The selected game will be displayed on a computer and performed using a breathing exercise headset integrated with a mouthpiece that detects exhalation. Each game will consist of 10 inhalation-exhalation cycles, and the game will automatically end once the 10 exhalations are completed. The mouthpiece used for the breathing exercise will be individually assigned to each participant. Prior to the procedure, children will be instructed to perform slow, deep inhalation through the nose followed by controlled exhalation through a mouthpiece. Accordingly, each child will first perform the breathing exercise for one minute, followed by a two-minute rest period during which preparations for venipuncture will be completed. The breathing exercise will be resumed one minute before the procedure and will continue throughout the venipuncture. Overall, each child will perform the breathing exercise for approximately three minutes during the procedure. Pain, fear, and anxiety levels will be assessed 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). Data will be analyzed using appropriate statistical methods, and the effectiveness of the intervention will be evaluated by comparing outcomes between the groups.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşenur AKKAYA GÜL, Assistant Professor; Phone Number: (0216) 910 19 07; Email: aysenurakkaya006@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group (Standard Venipuncture Procedure); Children in the control group will undergo the standard venipuncture procedure, including an explanation of the procedure and the use of reassuring expressions.
Experimental: 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. 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain management; Breathing exercise; Non-pharmacological intervention; Pediatric venipuncture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: GAMEBREATH-2026/AAKKAYAGUL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) may be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No