Virtual RealityNCT07138430
The Effect of Virtual Reality on Patient Outcome
A study testing intervention group in people with Virtual Reality and Coronary Angiography (CAG), run by HARUN ÜNAL at 1 site in Turkey (Türkiye).
Trial summary
This study explores the impact of virtual reality (VR) interventions on patient outcomes during coronary angiography procedures. It evaluates the effectiveness of VR in reducing patient anxiety, enhancing comfort, and improving overall satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Virtual Reality, Coronary Angiography (CAG)
- What is being tested?
- intervention group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Aug 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70,
- Who volunteer to participate in the study,
- Who are open to communication, who can read and write,
- Patients without visual or auditory impairments,
- Patients who have undergone femoral artery bypass grafting,
- Patients who have not received opioids or tranquilizers,
- Patients undergoing coronary angiography for the first time will be included in the study.
Who cannot join
- Patients who have difficulty using virtual reality glasses and who experience headaches, nausea, and vomiting
- Patients under the age of 18
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Patient Outcome in Coronary Angiography
This study explores the impact of virtual reality (VR) interventions on patient outcomes during coronary angiography procedures. It evaluates the effectiveness of VR in reducing patient anxiety, enhancing comfort, and improving overall satisfaction. The findings suggest that the use of VR as a non-pharmacological support tool can positively influence patients' emotional states, reduce perceived stress levels, and potentially improve cooperation during the procedure. These results highlight the potential of immersive technologies to support patient-centered care in interventional cardiology settings.
Read the detailed description
Coronary angiography is an essential diagnostic and interventional procedure widely used to assess coronary artery disease. Despite its clinical importance, many patients experience significant levels of anxiety, stress, and discomfort before and during the procedure, which can negatively impact their physiological responses and overall satisfaction. In recent years, non-pharmacological interventions, particularly immersive technologies such as virtual reality (VR), have been investigated for their potential to enhance the patient experience during medical procedures.
This study aimed to evaluate the effect of virtual reality on patient outcomes during coronary angiography. A controlled clinical trial design was employed to compare a group of patients exposed to a VR intervention-typically involving calming, immersive environments-against a control group receiving standard care. Key outcome measures included anxiety levels, pain perception, and overall patient satisfaction.
The study supports the integration of virtual reality as a complementary tool in cardiac catheterization laboratories to improve patient-centered outcomes. As technology becomes increasingly accessible, VR-based interventions may offer innovative solutions to reduce procedural stress and improve the quality of care in invasive cardiology.
- Conditions
- Virtual Reality, Coronary Angiography (CAG)
- Being tested
- intervention group, standard care and treatment.
- Keywords
- Coronary Angiography, Virtual Reality, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupOther
In this study, patients in the intervention group were informed about the coronary angiography procedure and the virtual reality application. After completing the "Patient Identifier Form," the "Visual Analog Scale," and the "State Anxiety Inventory" 20 minutes before the procedure, the patients were placed in the supine position in the procedure room to prepare for the procedure. Two minutes before the coronary angiography, the patients were fitted with virtual reality headsets, and throughout the procedure, they listened to images of nature, forests, and riverside areas, along with accompanying relaxing music. Twenty minutes after the procedure, the patients' pain, anxiety, and satisfaction levels were re-evaluated using the scales. One week after discharge, the patients were evaluated in the cardiology outpatient clinic for pain, hematoma, and edema in the femoral region, and the "Visual Analog Scale" was administered again.
standard care and treatment.Other
The pre-procedure preparations for patients in the control group were similar to those in the intervention group. Patients in this group received no other interventions during the coronary angiography procedure other than standard care and treatment. Control group patients completed the VAS and anxiety scale 20 minutes after the procedure. Post-discharge procedures for the control group were identical to those for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | In this study, patients in the intervention group were informed about the coronary angiography procedure and the virtual reality application. Receives: Other: intervention group |
| Control Group | Placebo comparator | Patients in this group received no other interventions during the coronary angiography procedure other than standard care and treatment. Receives: Other: standard care and treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
Description: This form, prepared by researchers based on literature review, consists of a total of 11 questions to question the socio-demographic characteristics and disease-related characteristics of patients.
Measured: 10 minutes
Visual Analog Scale
The VAS, whose validity and reliability study was conducted by Price et al. (1983), is a tool that subjectively assesses and measures people's pain experiences. The VAS is frequently used in assessing pain levels in adults and is considered the fastest and simplest to understand among single-dimensional scales. To determine pain intensity, the patient is asked to mark the score corresponding to the quantitative pain experienced on a 10-cm ruler, with the "0" point at one end representing "no pain" and the "10" point at the other end representing "the most severe pain." The scale can be applied horizontally or vertically. The point marked by the patient is used as numerical data to determine the level of pain perception. On this scale, a "0" point indicates no pain, while a "10" point describes the most severe pain.
Measured: 10 minutes
State Anxiety Scale
Description: The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Öner and Le Compte (1998). The scale consists of a total of 40 items and two separate scales. The first section includes the "State Anxiety Scale," which measures how a person feels at a specific moment, and the second section includes the "Trait Anxiety Scale," which includes statements about how a person feels in general. This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on a literature review and expert opinions.
Measured: 10 minutes
SATISFACTION EVALUATION SCALE
SATISFACTION EVALUATION SCALE Please indicate your level of satisfaction with the use of virtual reality headsets on a scale between 0 (zero) and 10 (ten).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Mar 2025
- Primary completion8 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- HARUN ÜNAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HARUN ÜNAL, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138430
- Sponsor's protocol ID
- 1903
- Status last verified
- Dec 2025
- First submitted
- 24 Jul 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Patient Outcome in Coronary Angiography
- ClinicalTrials.gov ID
- NCT07138430
- Acronym / sponsor ID
- 1903
- Conditions
- Virtual Reality, Coronary Angiography (CAG)
- Keywords
- Coronary Angiography, Virtual Reality, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- HARUN ÜNALUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 22 Aug 2025 (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.
This study explores the impact of virtual reality (VR) interventions on patient outcomes during coronary angiography procedures. It evaluates the effectiveness of VR in reducing patient anxiety, enhancing comfort, and improving overall satisfaction. The findings suggest that the use of VR as a non-pharmacological support tool can positively influence patients' emotional states, reduce perceived stress levels, and potentially improve cooperation during the procedure. These results highlight the potential of immersive technologies to support patient-centered care in interventional cardiology settings.
Detailed description
Coronary angiography is an essential diagnostic and interventional procedure widely used to assess coronary artery disease. Despite its clinical importance, many patients experience significant levels of anxiety, stress, and discomfort before and during the procedure, which can negatively impact their physiological responses and overall satisfaction. In recent years, non-pharmacological interventions, particularly immersive technologies such as virtual reality (VR), have been investigated for their potential to enhance the patient experience during medical procedures.
This study aimed to evaluate the effect of virtual reality on patient outcomes during coronary angiography. A controlled clinical trial design was employed to compare a group of patients exposed to a VR intervention-typically involving calming, immersive environments-against a control group receiving standard care. Key outcome measures included anxiety levels, pain perception, and overall patient satisfaction.
The study supports the integration of virtual reality as a complementary tool in cardiac catheterization laboratories to improve patient-centered outcomes. As technology becomes increasingly accessible, VR-based interventions may offer innovative solutions to reduce procedural stress and improve the quality of care in invasive cardiology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: intervention groupIn this study, patients in the intervention group were informed about the coronary angiography procedure and the virtual reality application. |
| Control Group | Placebo comparator | Other: standard care and treatment.Patients in this group received no other interventions during the coronary angiography procedure other than standard care and treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 18-70,
- Who volunteer to participate in the study,
- Who are open to communication, who can read and write,
- Patients without visual or auditory impairments,
- Patients who have undergone femoral artery bypass grafting,
Key exclusion criteria (3 listed)
- Patients who have difficulty using virtual reality glasses and who experience headaches, nausea, and vomiting
- Patients under the age of 18
- Pregnant patients
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 |
|---|---|---|
| intervention groupIn this study, patients in the intervention group were informed about the coronary angiography procedure and the virtual reality application. After completing the "Patient Identifier Form," the "Visual Analog Scale," and the "State Anxiety Inventory" 20 minutes before the procedure, the patients were placed in the supine position in the procedure room to prepare for the procedure. Two minutes before the coronary angiography, the patients were fitted with virtual reality headsets, and throughout the procedure, they listened to images of nature, forests, and riverside areas, along with accompanying relaxing music. Twenty minutes after the procedure, the patients' pain, anxiety, and satisfaction levels were re-evaluated using the scales. One week after discharge, the patients were evaluated in the cardiology outpatient clinic for pain, hematoma, and edema in the femoral region, and the "Visual Analog Scale" was administered again. | Other | intervention group |
| standard care and treatment.The pre-procedure preparations for patients in the control group were similar to those in the intervention group. Patients in this group received no other interventions during the coronary angiography procedure other than standard care and treatment. Control group patients completed the VAS and anxiety scale 20 minutes after the procedure. Post-discharge procedures for the control group were identical to those for the intervention group. | Other | Control Group |
Primary outcome
Patient Identification Form
Time frame: 10 minutes
Description: This form, prepared by researchers based on literature review, consists of a total of 11 questions to question the socio-demographic characteristics and disease-related characteristics of patients.
Visual Analog Scale
Time frame: 10 minutes
The VAS, whose validity and reliability study was conducted by Price et al. (1983), is a tool that subjectively assesses and measures people's pain experiences. The VAS is frequently used in assessing pain levels in adults and is considered the fastest and simplest to understand among single-dimensional scales. To determine pain intensity, the patient is asked to mark the score corresponding to the quantitative pain experienced on a 10-cm ruler, with the "0" point at one end representing "no pain" and the "10" point at the other end representing "the most severe pain." The scale can be applied horizontally or vertically. The point marked by the patient is used as numerical data to determine the level of pain perception. On this scale, a "0" point indicates no pain, while a "10" point describes the most severe pain.
State Anxiety Scale
Time frame: 10 minutes
Description: The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Öner and Le Compte (1998). The scale consists of a total of 40 items and two separate scales. The first section includes the "State Anxiety Scale," which measures how a person feels at a specific moment, and the second section includes the "Trait Anxiety Scale," which includes statements about how a person feels in general. This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on a literature review and expert opinions.
SATISFACTION EVALUATION SCALE
Time frame: 5 minutes
SATISFACTION EVALUATION SCALE Please indicate your level of satisfaction with the use of virtual reality headsets on a scale between 0 (zero) and 10 (ten).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Virtual Reality and Coronary Angiography (CAG), run by HARUN ÜNAL 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 12 Dec 2025. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Identification Form (time frame: 10 minutes). The study lists 4 primary outcomes in all. 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 12 Dec 2025.