Coronary AngiographyNCT04521660
The Effect of Using Virtual Reality Glasses During Coronary Angiography
A study testing Virtual reality glasses in people with Coronary Angiography, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Coronary angiography (CAG) is a diagnostic method used as the gold standard in the diagnosis of coronary artery disease (CAD), which is increasingly prevalent in developed and developing countries and is one of the leading causes of morbidity and mortality in the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- To experience coronary angiography for the first time
- Not having contraindications for coronary angiography
- Not having visual and hearing impairment
- To be orientation to place, time and person
- Not having mental deficiency
Show all 9Show fewer
- Not being addicted to alcohol and drugs
- Not being diagnosed with a psychiatric illness
- Having agreed to participate in research
Who cannot join
- Having undergone a treatment procedure (stent, balloon, etc.) during coronary angiography
- Having had a radial coronary angiography
- Not wanting to participate in the study
- Have used any painkillers at least 5 hours before coronary angiography
- Making coronary angiography decision under emergency conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Sağlık Bilimleri
Istanbul, 03445
About this study
Official title: The Effect of Using Virtual Reality Glasses on Pain, Anxiety and Hemodynamic Parameters During Coronary Angiography: A Randomized Controlled Trial
Coronary angiography (CAG) is a diagnostic method used as the gold standard in the diagnosis of coronary artery disease (CAD), which is increasingly prevalent in developed and developing countries and is one of the leading causes of morbidity and mortality in the world. Although coronary angiography is one of the best diagnostic methods of CAD, it can cause psychological problems such as stress, fear, anxiety in patients; It also causes physical problems such as bleeding, hematom and pain. Pharmacological and non-pharmacological methods are used by nurses to solve problems of patients, to ensure their relaxation and to improve their quality of life. With the development of technology, virtual reality (VR) glasses have been used to have fun at first, and later to provide pain management and to solve anxiety problems. VR glasses are an advanced technology that allows the patient to move into a virtual world and focus his attention on other thoughts, giving less attention to pain and anxiety. During literature search, no studies were found about the effect of using SG glasses on pain and anxiety during CAG. This research will be conducted to determine the effect of VR glasses used during CAG on pain, anxiety and hemodynamic parameters of patients who will experience coronary angiography for the first time.
Read the detailed description
Although coronary angiography is widely used in the diagnosis and evaluation of CAD and heart valve diseases, it causes patients to experience intense stress, anxiety, pain and even fear of death. The main purpose of nurses before an interventional procedure is to increase the physiological and mental well-being of the patient and to help them adapt to the procedure. Various pharmacological and non-pharmacological methods are used to manage the psychological and physical problems of patients undergoing coronary angiography. Distraction is one of the non-pharmacological interventions commonly used during medical procedures. Virtual reality (VR) is a new method that can be used to distract and prepare patients for the procedure during medical procedures. It is thought to be more effective than traditional methods. Virtual reality is a computer-generated environment in which three-dimensional interaction is possible. It projects a wide field of view in front of the user's eye through advanced head-worn screens (glasses). It is an advanced technology that allows the individual to move into a virtual environment and focus his attention on other thoughts to less consideration for pain and anxiety.
This study is a randomized controlled study to determine the effectiveness of virtual reality glasses on pain, anxiety and hemodynamic parameters during coronary angiography.The universe of the study will be the individuals who will have a coronary angiography in the Angiography Laboratory of the Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital. On the other hand, the sample of the study will consist of patients who meet the inclusion criteria within the time the study is planned. Power analysis was performed using the G * Power (v3.1.7) program to determine the number of samples. It was decided that there should be at least 64 people in the groups. Participants in the study will be randomly divided into two groups as intervention and control groups. Before the procedure, patients will be informed about the purpose of the study, and written and verbal informed consent will be obtained from the patients. Patients in both groups will be asked to fill in the Personal Information Form before the procedure, and their pain levels will be evaluated with the Visual Analogue Scale (VAS), and their anxiety levels will be evaluated with the State-Trait Anxiety Inventory I (STAI-I). Immediately after the procedure, the pain levels of the patients with VAS and their anxiety levels will be evaluated with STAI-I. Virtual reality glasses will be worn on the intervention group just before the procedure starts and patients will continue to wear VR glasses until the procedure is completed. In patients selected as the control group, the same evaluations will be made at the same time interval. SPSS 22.0 (Statistical Package of Social Sciences) package program will be used for statistical analysis.
- Conditions
- Coronary Angiography
- Being tested
- Virtual reality glasses
- Keywords
- virtual reality, pain, anxiety, hemodynamic parameters, angiography
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesDevice
Virtual reality (VR) is a new method that can be used to distract and prepare patients for the procedure during medical procedures. It is an advanced technology that allows the individual to move into a virtual environment and focus his attention on other thoughts to less consideration for pain and anxiety. In this study, VR glasses will be worn on the intervention group just before the procedure begins and patients will continue to wear their glasses until the procedure is completed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in the intervention group will wear virtual reality glasses during coronary angiography. Receives: Device: Virtual reality glasses |
| Control group | No intervention | Patients in the control group will not wear virtual reality glasses. They will be given standard care and treatment during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on pain intensity as measured by Visual Analog Scale
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.
Measured: 'just before procedure and 30 minutes after procedure
Secondary outcomes (1)
Score change on anxiety level as measured by State-Trait Anxiety Inventory
The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.
Measured: just before procedure and 30 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start20 Nov 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Why it stopped: The study was terminated prematurely due to the primary investigator's withdrawal from the graduate program, leaving the protocol incomplete."
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci Akpinar, Saglik Bilimleri Universitesi
- Investigators
- Rabia Ermis, Study chair, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521660
- Sponsor's protocol ID
- 20-94
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Reality Glasses on Pain, Anxiety and Hemodynamic Parameters During Coronary Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04521660
- Acronym / sponsor ID
- 20-94
- Conditions
- Coronary Angiography
- Keywords
- virtual reality, pain, anxiety, hemodynamic parameters, angiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to the primary investigator's withdrawal from the graduate program, leaving the protocol incomplete."
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 20 Aug 2020 (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.
Coronary angiography (CAG) is a diagnostic method used as the gold standard in the diagnosis of coronary artery disease (CAD), which is increasingly prevalent in developed and developing countries and is one of the leading causes of morbidity and mortality in the world. Although coronary angiography is one of the best diagnostic methods of CAD, it can cause psychological problems such as stress, fear, anxiety in patients; It also causes physical problems such as bleeding, hematom and pain. Pharmacological and non-pharmacological methods are used by nurses to solve problems of patients, to ensure their relaxation and to improve their quality of life. With the development of technology, virtual reality (VR) glasses have been used to have fun at first, and later to provide pain management and to solve anxiety problems. VR glasses are an advanced technology that allows the patient to move into a virtual world and focus his attention on other thoughts, giving less attention to pain and anxiety. During literature search, no studies were found about the effect of using SG glasses on pain and anxiety during CAG. This research will be conducted to determine the effect of VR glasses used during CAG on pain, anxiety and hemodynamic parameters of patients who will experience coronary angiography for the first time.
Detailed description
Although coronary angiography is widely used in the diagnosis and evaluation of CAD and heart valve diseases, it causes patients to experience intense stress, anxiety, pain and even fear of death. The main purpose of nurses before an interventional procedure is to increase the physiological and mental well-being of the patient and to help them adapt to the procedure. Various pharmacological and non-pharmacological methods are used to manage the psychological and physical problems of patients undergoing coronary angiography. Distraction is one of the non-pharmacological interventions commonly used during medical procedures. Virtual reality (VR) is a new method that can be used to distract and prepare patients for the procedure during medical procedures. It is thought to be more effective than traditional methods. Virtual reality is a computer-generated environment in which three-dimensional interaction is possible. It projects a wide field of view in front of the user's eye through advanced head-worn screens (glasses). It is an advanced technology that allows the individual to move into a virtual environment and focus his attention on other thoughts to less consideration for pain and anxiety.
This study is a randomized controlled study to determine the effectiveness of virtual reality glasses on pain, anxiety and hemodynamic parameters during coronary angiography.The universe of the study will be the individuals who will have a coronary angiography in the Angiography Laboratory of the Department of Cardiology, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital. On the other hand, the sample of the study will consist of patients who meet the inclusion criteria within the time the study is planned. Power analysis was performed using the G * Power (v3.1.7) program to determine the number of samples. It was decided that there should be at least 64 people in the groups. Participants in the study will be randomly divided into two groups as intervention and control groups. Before the procedure, patients will be informed about the purpose of the study, and written and verbal informed consent will be obtained from the patients. Patients in both groups will be asked to fill in the Personal Information Form before the procedure, and their pain levels will be evaluated with the Visual Analogue Scale (VAS), and their anxiety levels will be evaluated with the State-Trait Anxiety Inventory I (STAI-I). Immediately after the procedure, the pain levels of the patients with VAS and their anxiety levels will be evaluated with STAI-I. Virtual reality glasses will be worn on the intervention group just before the procedure starts and patients will continue to wear VR glasses until the procedure is completed. In patients selected as the control group, the same evaluations will be made at the same time interval. SPSS 22.0 (Statistical Package of Social Sciences) package program will be used for statistical analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Virtual reality glassesPatients in the intervention group will wear virtual reality glasses during coronary angiography. |
| Control group | No intervention | –Patients in the control group will not wear virtual reality glasses. They will be given standard care and treatment during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being 18 years or older
- To experience coronary angiography for the first time
- Not having contraindications for coronary angiography
- Not having visual and hearing impairment
- To be orientation to place, time and person
Key exclusion criteria (5 listed)
- Having undergone a treatment procedure (stent, balloon, etc.) during coronary angiography
- Having had a radial coronary angiography
- Not wanting to participate in the study
- Have used any painkillers at least 5 hours before coronary angiography
- Making coronary angiography decision under emergency conditions
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 glassesVirtual reality (VR) is a new method that can be used to distract and prepare patients for the procedure during medical procedures. It is an advanced technology that allows the individual to move into a virtual environment and focus his attention on other thoughts to less consideration for pain and anxiety. In this study, VR glasses will be worn on the intervention group just before the procedure begins and patients will continue to wear their glasses until the procedure is completed. | Device | Intervention group |
Primary outcome
Change on pain intensity as measured by Visual Analog Scale
Time frame: 'just before procedure and 30 minutes after procedure
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.
1 secondary outcome
Score change on anxiety level as measured by State-Trait Anxiety Inventory
Time frame: just before procedure and 30 minutes after procedure
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to the primary investigator's withdrawal from the graduate program, leaving the protocol incomplete."). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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. This study is not recruiting at the moment.
Rabia Ermis study chair
Saglik Bilimleri University
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 glasses in people with Coronary Angiography, run by Saglik Bilimleri Universitesi 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?
The sponsor lists 9 inclusion and 5 exclusion criteria. 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: stopped early, as of the sponsor's last update on 2 Oct 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?
The study was stopped early (reason given: The study was terminated prematurely due to the primary investigator's withdrawal from the graduate program, leaving the protocol incomplete."). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on pain intensity as measured by Visual Analog Scale (time frame: 'just before procedure and 30 minutes after procedure). 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 2 Oct 2026.