An interventional study of Virtual Reality-Based Guided Breathing Exercise in Anxiety and Angiocardiography, sponsored by Gazi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Gazi University · Not applicable, Interventional, and Supportive care
hildren undergoing angiography frequently experience anxiety before the procedure, which may negatively affect physiological parameters and procedural cooperation. Although pharmacological approaches are commonly used to reduce anxiety, they may be associated with adverse effects and are not always necessary. Virtual reality (VR)-based guided breathing exercises offer a non-pharmacological approach that combines immersive distraction with breathing techniques to promote relaxation.
This randomized controlled trial aims to evaluate the effect of a VR-based guided breathing exercise administered before angiography on anxiety and physiological parameters in children aged 9-18 years. A total of 60 participants will be randomly assigned to either a VR-based guided breathing exercise group or a standard care group. Anxiety and physiological parameters, including heart rate, blood pressure, respiratory rate, oxygen saturation, and body temperature, will be assessed before and after the intervention. The findings of this study may provide evidence for the use of VR-based guided breathing exercises as a safe and effective nursing intervention to reduce pre-procedural anxiety in pediatric patients.
Children undergoing angiography frequently experience anxiety before the procedure because of unfamiliar hospital environments, uncertainty about the procedure, and fear of invasive interventions. Increased pre-procedural anxiety may negatively affect physiological parameters, procedural cooperation, and the overall treatment experience. Therefore, effective and safe non-pharmacological interventions are needed to improve children's psychological well-being before angiography.
Virtual reality (VR) has emerged as an effective non-pharmacological intervention for reducing anxiety by providing immersive distraction and promoting relaxation. Combining VR with guided breathing exercises may further enhance relaxation through activation of the parasympathetic nervous system and improvement of emotional regulation. Although VR and breathing exercises have separately demonstrated beneficial effects in pediatric populations, evidence regarding their combined use before pediatric angiography remains limited.
The aim of this randomized controlled trial is to evaluate the effect of a VR-based guided breathing exercise administered before angiography on anxiety and physiological parameters in children aged 9 to 18 years undergoing elective angiography.
A total of 60 participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a single session of an approximately 7-8-minute VR-based guided breathing exercise before angiography in addition to standard care. Participants in the control group will receive standard pre-procedural care alone.
The primary outcome will be state anxiety. Secondary outcomes will include heart rate, blood pressure, respiratory rate, oxygen saturation, body temperature, and self-reported relaxation/satisfaction. Outcomes will be assessed immediately before and immediately after the intervention.
The findings of this study are expected to provide evidence regarding the effectiveness of VR-based guided breathing exercises as a safe, feasible, and non-pharmacological nursing intervention for reducing anxiety and improving physiological responses in children undergoing angiography.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria Children aged 9 to 18 years. Diagnosed with congenital heart disease. Scheduled to undergo elective angiography. Able to understand and communicate in Turkish. Participant and parent/legal guardian willing to provide written informed assent and consent.
Clinically stable and able to participate in a virtual reality-based guided breathing exercise.
Exclusion Criteria Undergoing emergency angiography. Visual, hearing, cognitive, or neurological impairments that would interfere with participation in the virtual reality intervention or completion of study assessments.
Use of sedative, anxiolytic, hypnotic, or opioid medications before the intervention.
Inability to tolerate the virtual reality headset or development of significant cybersickness during the intervention.
Withdrawal of assent or parental/legal guardian consent.
Participants assigned to the experimental group will receive a single session of a virtual reality-based guided breathing exercise lasting approximately 7-8 minutes before angiography in addition to routine pre-procedural nursing care. The intervention consists of an immersive, nature-based virtual reality experience combined with guided slow-breathing instructions.
Behavioral: Virtual Reality-Based Guided Breathing Exercise
Participants assigned to the control group will receive routine pre-procedural nursing care before angiography according to the hospital's standard clinical practice. No virtual reality-based guided breathing exercise will be provided.
A single 5-7-minute virtual reality-based guided breathing exercise delivered before angiography. Participants will wear a virtual reality headset displaying immersive natural scenery while following standardized breathing instructions designed to promote relaxation and reduce pre-procedural anxiety.
State Anxiety
State anxiety will be assessed using the State Anxiety Inventory for Children. Higher scores indicate greater levels of state anxiety. Assessments will be performed immediately before and immediately after the interventio
Time frame: Immediately before the intervention and immediately after the intervention (approximately 10 minutes).
Heart Rate
Heart rate will be measured in beats per minute using the standard clinical monitoring device. Measurements will be obtained immediately before and immediately after the intervention.
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Blood Pressure
Systolic and diastolic blood pressure will be measured in millimeters of mercury using a calibrated clinical blood pressure monitor. Measurements will be obtained immediately before and immediately after the intervention
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Respiratory Rate
Respiratory rate will be measured as breaths per minute immediately before and immediately after the intervention.
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Peripheral Oxygen Saturation
Peripheral oxygen saturation will be measured as a percentage using pulse oximetry immediately before and immediately after the intervention.
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 10 months later.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 10 months is below that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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