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NCT Number: NCT07830420

Virtual Reality-Based Breathing Exercise Before Angiography in Children

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.

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Key information

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06500, Turkey (Türkiye)

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Virtual Reality-Based Guided Breathing Exercise

Behavioral

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.

Primary outcomes

  1. State Anxiety

    Time frame: 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

Secondary outcomes

  1. Heart Rate

    Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.

    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.

  2. Blood Pressure

    Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.

    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

  3. Respiratory Rate

    Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.

    Respiratory rate will be measured as breaths per minute immediately before and immediately after the intervention.

  4. Peripheral Oxygen Saturation

    Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.

    Peripheral oxygen saturation will be measured as a percentage using pulse oximetry immediately before and immediately after the intervention.

Study contacts

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

Çiğdem SARI ÖZTÜRK, PhD

CONTACT

[email protected]

+90 312 216 26 63

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Effect of Virtual Reality-Based Guided Breathing Exercise Before Angiography on Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 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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