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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Устройство 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.

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: 1 minute before the intervention, during the intervention, and immediately after the intervention]
• Children's Anxiety Scale-State (CAS-S) [Срок оценки: 1 minute before the intervention, and immediately after the intervention]
• Child Fear Scale (CFS) [Срок оценки: 1 minute before the intervention, during the intervention, and immediately after the intervention]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07550062 · GAMEBREATH-2026/AAKKAYAGUL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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