AnxietyNCT07830420
Virtual Reality-Based Breathing Exercise Before Angiography in Children
A study testing Virtual Reality-Based Guided Breathing Exercise in people with Anxiety and Angiocardiography, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Anxiety, Angiocardiography
- What is being tested?
- Virtual Reality-Based Guided Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06500
cigdemsari@gazi.edu.tr
About this study
Official title: Effect of Virtual Reality-Based Guided Breathing Exercise Before Angiography on Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Anxiety, Angiocardiography
- Being tested
- Virtual Reality-Based Guided Breathing Exercise
- Keywords
- children, adolescent, angiography, Virtual Reality, Breathing Exercise, Physiological Parameters
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Guided Breathing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately before the intervention and immediately after the intervention (approximately 10 minutes).
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Sarı Öztürk, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830420
- Sponsor's protocol ID
- Gazi University-2026
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-Based Guided Breathing Exercise Before Angiography on Anxiety and Physiological Parameters in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07830420
- Acronym / sponsor ID
- Gazi University-2026
- Conditions
- Anxiety, Angiocardiography
- Keywords
- children, adolescent, angiography, Virtual Reality, Breathing Exercise, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Virtual Reality-Based Guided Breathing ExerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based Guided Breathing ExerciseA 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. | Behavioural | experimental |
Primary outcome
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
4 secondary outcomes
Heart Rate
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Blood Pressure
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Respiratory Rate
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Peripheral Oxygen Saturation
Time frame: Immediately before and immediately after the intervention, approximately 10 minutes apart.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Guided Breathing Exercise in people with Anxiety and Angiocardiography, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Çiğdem SARI ÖZTÜRK, PhD (+90 312 216 26 63, cigdemsari@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (time frame: Immediately before the intervention and immediately after the intervention (approximately 10 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.