Non-Pharmacological InterventionsNCT07550062
Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture
A study testing Intervention Group (Video Game-Based Breathing Exercise During Venipuncture) and Video Game-Based Breathing Exercise Device in people with Non-Pharmacological Interventions and Breathing Exercise, run by Uludag University.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Pharmacological Interventions, Breathing Exercise, Venipuncture Pain
- What is being tested?
- Intervention Group (Video Game-Based Breathing Exercise During Venipuncture) and Video Game-Based Breathing Exercise Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- Intervention Group (Video Game-Based Breathing Exercise During Venipuncture), Video Game-Based Breathing Exercise Device
- Keywords
- Pediatric venipuncture, Pain management, Breathing exercise, Non-pharmacological intervention
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture); Device: Video Game-Based Breathing Exercise Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 minute before the intervention, during the intervention, and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Pharmacological InterventionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Akkaya Gul, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550062
- Sponsor's protocol ID
- GAMEBREATH-2026/AAKKAYAGUL
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07550062
- Acronym / sponsor ID
- GAMEBREATH-2026/AAKKAYAGUL
- Keywords
- Pediatric venipuncture, Pain management, Breathing exercise, Non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture), Device: Video Game-Based Breathing Exercise DeviceChildren 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Being between 7-12 years of age
Key exclusion criteria (5 listed)
- • History of epilepsy or recurrent seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention Group (Video Game-Based Breathing Exercise During Venipuncture) |
| Video Game-Based Breathing Exercise DeviceThe 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. | Device | Intervention Group (Video Game-Based Breathing Exercise During Venipuncture) |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group (Video Game-Based Breathing Exercise During Venipuncture) and Video Game-Based Breathing Exercise Device in people with Non-Pharmacological Interventions and Breathing Exercise, run by Uludag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur AKKAYA GÜL, Assistant Professor ((0216) 910 19 07, aysenurakkaya006@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 1 minute before the intervention, during the intervention, and immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.