Effect of Virtual Reality-Based Guided Breathing Exercise Before Angiography on Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- State Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group allocation. Participants will not be informed whether they are assigned to the intervention or control group. Outcome assessments will be performed by assessors who are unaware of participants' group assignments. Group allocation codes will remain concealed until completion of data analysis to minimize assessment bias.
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
experimental
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.
干预措施: Virtual Reality-Based Guided Breathing Exercise (Behavioral)
standart care
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.
结局指标
主要结局
State Anxiety
时间窗: Immediately before the intervention and immediately after the intervention (approximately 10 minutes).
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
次要结局
- Heart Rate(Immediately before and immediately after the intervention, approximately 10 minutes apart.)
- Blood Pressure(Immediately before and immediately after the intervention, approximately 10 minutes apart.)
- Respiratory Rate(Immediately before and immediately after the intervention, approximately 10 minutes apart.)
- Peripheral Oxygen Saturation(Immediately before and immediately after the intervention, approximately 10 minutes apart.)
研究者
Çiğdem Sarı Öztürk
Associate Professor
Gazi University