Virtual Reality-Based Breathing Exercise Before Angiography in Children

NCT07830420 | Not Yet Recruiting

• 1 other identifier: Gazi University-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Angiocardiography

Keywords

children; adolescent; angiography; Virtual Reality; Breathing Exercise; Physiological Parameters

Outcome Measures

Primary Outcomes (1)

• 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

  Immediately before the intervention and immediately after the intervention (approximately 10 minutes).

Secondary Outcomes (4)

• 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.

Study Arms (2)

experimental

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.

Behavioral: Virtual Reality-Based Guided Breathing Exercise

standart care

NO INTERVENTION

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.

Interventions

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.

experimental

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinically stable and able to participate in a virtual reality-based guided breathing exercise.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Çiğdem SARI ÖZTÜRK, PhD

CONTACT

+90 312 216 26 63; cigdemsari@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either a virtual reality-based guided breathing exercise group or a standard care control group. The intervention will be administered once before angiography, and outcomes will be assessed before and immediately after the intervention.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)