Coronary Angiography (CAG)NCT07087990
Effect of VR Glasses and Stress Ball on Anxiety in Coronary Angiography Patients
A study testing Virtual Reality Glasses and Stress Ball in people with Coronary Angiography (CAG) and Anxiety, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Angiography (CAG), Anxiety, Pain
- What is being tested?
- Virtual Reality Glasses and Stress Ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study
- Age 18 years or older
- Undergoing coronary angiography for the first time
- Cognitive ability to answer the questions
- No diagnosis of anxiety disorder and no use of medication for anxiety / no psychiatric diagnosis
- No physical disability preventing the use of the stress ball
- No problems with vision, hearing, or understanding
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses and Stress Ball on Anxiety, Pain, and Satisfaction in Patients Undergoing Coronary Angiography: A Randomized Controlled Study
This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.
Read the detailed description
This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.
- Conditions
- Coronary Angiography (CAG), Anxiety, Pain
- Being tested
- Virtual Reality Glasses, Stress Ball
- Keywords
- Coronary Angiography, Virtual Reality, Stress Balls, Anxiety, pain, Satisfaction Levels
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
articipants in the VR group used virtual reality glasses during coronary angiography to reduce anxiety and pain and improve satisfaction.
Stress BallOther
articipants in the stress ball group used a stress ball during coronary angiography to evaluate its effects on anxiety, pain, and satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| VR Group"Participants in this group were provided with virtual reality glasses during coronary angio | Experimental | Participants in this group were provided with virtual reality glasses during coronary angiography to assess the effect on anxiety, pain, and satisfaction. Receives: Device: Virtual Reality Glasses |
| Stress Ball Group | Experimental | Participants in this group used a stress ball during coronary angiography to evaluate its effect on anxiety, pain, and satisfaction. Receives: Other: Stress Ball |
| Control Group | No intervention | Participants in this group received standard care during coronary angiography without the use of virtual reality glasses or stress ball. Anxiety, pain, and satisfaction levels were assessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Inventory (SAI) Scores
the study will measure changes in situational anxiety levels of patients undergoing coronary angiography, using the State Anxiety Inventory (SAI) before and after the procedure with virtual reality glasses and stress balls. The SAI consists of 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80; higher scores indicate higher anxiety.
Measured: Before and immediately after coronary angiography procedure
Secondary outcomes (2)
Change in Anxiety Visual Analogue Scale (VAS) Scores
Patients' anxiety levels will be assessed before and after coronary angiography using a 10 cm Visual Analogue Scale (VAS), where 0 indicates no anxiety and 10 indicates extreme anxiety.
Measured: Before and immediately after coronary angiography procedure
Change in Pain Visual Analogue Scale (VAS) Scores
Patients' pain levels will be evaluated before and after coronary angiography using a 10 cm Visual Analogue Scale (VAS), where 0 means no pain and 10 indicates worst possible pain.
Measured: Before and immediately after coronary angiography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Mar 2025
- Primary completion30 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Angiography (CAG)Studies 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
- randomize kontrollü
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Ozdemir, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz Özer, PhD, Study chair, İstanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087990
- Sponsor's protocol ID
- IZU-EC-2024-10
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, individual participant data (IPD) will not be shared due to concerns about patient privacy and confidentiality. Additionally, data sharing procedures are still under development. We are committed to protecting participants' personal information in accordance with applicable regulations and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses and Stress Ball on Anxiety, Pain, and Satisfaction in Patients Undergoing Coronary Angiography: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07087990
- Acronym / sponsor ID
- IZU-EC-2024-10
- Conditions
- Coronary Angiography (CAG), Anxiety, Pain
- Keywords
- Coronary Angiography, Virtual Reality, Stress Balls, Anxiety, pain, Satisfaction Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 28 Jul 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 randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.
Detailed description
This randomized controlled trial aimed to evaluate the effects of virtual reality (VR) glasses and the use of a stress ball on anxiety, pain, and satisfaction levels in patients undergoing coronary angiography. Participants were randomly assigned to three groups: one group received both VR and stress ball interventions during the procedure, while the control group received standard care. Anxiety, pain, and satisfaction levels were assessed and compared across the three groups at the conclusion of the procedure. The study seeks to contribute to evidence on non-pharmacological methods to improve patient comfort during invasive cardiac procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomize kontrollü
| Arm | Type | Receives |
|---|---|---|
| VR Group"Participants in this group were provided with virtual reality glasses during coronary angio | Experimental | Device: Virtual Reality GlassesParticipants in this group were provided with virtual reality glasses during coronary angiography to assess the effect on anxiety, pain, and satisfaction. |
| Stress Ball Group | Experimental | Other: Stress BallParticipants in this group used a stress ball during coronary angiography to evaluate its effect on anxiety, pain, and satisfaction. |
| Control Group | No intervention | –Participants in this group received standard care during coronary angiography without the use of virtual reality glasses or stress ball. Anxiety, pain, and satisfaction levels were assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary participation in the study
- Age 18 years or older
- Undergoing coronary angiography for the first time
- Cognitive ability to answer the questions
- No diagnosis of anxiety disorder and no use of medication for anxiety / no psychiatric diagnosis
Key exclusion criteria (1 listed)
- None
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 Glassesarticipants in the VR group used virtual reality glasses during coronary angiography to reduce anxiety and pain and improve satisfaction. | Device | VR Group"Participants in this group were provided with virtual reality glasses during coronary angio |
| Stress Ballarticipants in the stress ball group used a stress ball during coronary angiography to evaluate its effects on anxiety, pain, and satisfaction. | Other | Stress Ball Group |
Primary outcome
Change in State Anxiety Inventory (SAI) Scores
Time frame: Before and immediately after coronary angiography procedure
the study will measure changes in situational anxiety levels of patients undergoing coronary angiography, using the State Anxiety Inventory (SAI) before and after the procedure with virtual reality glasses and stress balls. The SAI consists of 20 items rated on a 4-point Likert scale, with total scores ranging from 20 to 80; higher scores indicate higher anxiety.
2 secondary outcomes
Change in Anxiety Visual Analogue Scale (VAS) Scores
Time frame: Before and immediately after coronary angiography procedure
Change in Pain Visual Analogue Scale (VAS) Scores
Time frame: Before and immediately after coronary angiography procedure
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 30 Jul 2025.
- Individual participant dataSharing planned: No. At this time, individual participant data (IPD) will not be shared due to concerns about patient privacy and confidentiality. Additionally, data sharing procedures are still under development. We are committed to protecting participants' personal information in accordance with applicable regulations and institutional policies.
Related trials for Coronary Angiography (CAG)
Recruiting
CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
The Effect of Virtual Reality Glasses on Vital Signs and State Anxiety in Patients Undergoing Coronary Angiography
Coronary Angiography (CAG)
Recruiting
Serpentine vs Traditional Hydrophilic Guidewire Tracking in Complex Radial Anatomy
Transradial Access(TRA), Coronary Angiography (CAG)
Recruiting
Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels
Coronary Artery Disease
Not yet recruiting
Effect of Virtual Reality Glasses on Stress, Muscle Tension, and Physiological Parameters Before Angiography
Coronary Angiography (CAG)
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.
Zülfünaz Özer, PhD study chair
İstanbul Sabahattin Zaim 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 and Stress Ball in people with Coronary Angiography (CAG) and Anxiety, run by Istanbul Sabahattin Zaim 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?
The sponsor lists 7 inclusion and 1 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 30 Jul 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. 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?
Change in State Anxiety Inventory (SAI) Scores (time frame: Before and immediately after coronary angiography 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 30 Jul 2025.