Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture), Video Game-Based Breathing Exercise Device.
- Who it may be relevant to
- Registry conditions: Non-Pharmacological Interventions, Breathing Exercise, Venipuncture Pain, Pain Management. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
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.
Primary outcome measures
- Visual Analog Scale (VAS) [Time frame: 1 minute before the intervention, during the intervention, and immediately after the intervention]
- Children's Anxiety Scale-State (CAS-S) [Time frame: 1 minute before the intervention, and immediately after the intervention]
- Child Fear Scale (CFS) [Time frame: 1 minute before the intervention, during the intervention, and immediately after the intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07550062 · GAMEBREATH-2026/AAKKAYAGUL