Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture (NCT07550062) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture
60 participantsStarted 2026-05
Plain-language 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 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.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My child is really scared of blood draws — could a game-based breathing exercise approach like the one in this trial realistically help reduce their pain and fear during venipuncture, or are there already proven techniques your team uses that might work just as well?
2This trial is listed as 'not yet recruiting,' so it isn't open yet — do you know when it might start, and is there any way to get on a waitlist or be notified if my child might be a good fit to discuss later?
3The trial measures anxiety and fear using specific children's scales like the Children's Anxiety Scale and Child Fear Scale — how severe does my child's fear or distress around needles need to be for this kind of research to be worth considering versus just trying standard comfort measures?
4Since this is a Phase N/A study focused on a non-drug intervention like guided breathing through a game, what risks or downsides, if any, should I be aware of for my child compared to simply having them do a standard blood draw without any special intervention?
5Are there similar non-pharmacological techniques your clinic already offers, like distraction tools or guided breathing, that my child could try right now while this trial is still in the planning stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS)
Timeframe: 1 minute before the intervention, during the intervention, and immediately after the intervention
2
Children's Anxiety Scale-State (CAS-S)
Timeframe: 1 minute before the intervention, and immediately after the intervention
3
Child Fear Scale (CFS)
Timeframe: 1 minute before the intervention, during the intervention, and immediately after the intervention