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NCT Number: NCT07550062

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 1 minute before the intervention, during the intervention, and immediately after the intervention

    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.

  2. Children's Anxiety Scale-State (CAS-S)

    Time frame: 1 minute before the intervention, and immediately after the intervention

    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.

  3. Child Fear Scale (CFS)

    Time frame: 1 minute before the intervention, during the intervention, and immediately after the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşenur AKKAYA GÜL, Assistant Professor

CONTACT

[email protected]

(0216) 910 19 07

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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