Coronary Artery DiseaseNCT07320248
Virtual Reality for Patient Preparation Before Cardiac Catheterization in Oman
A study testing Virtual Reality Education in people with Coronary Artery Disease and Ischaemic Heart Desease, run by Sultan Qaboos University.
Trial summary
Background: Cardiovascular disease is considered one of the most prevalent diseases in recent times, and cardiac catheterization is widely used to diagnose and treat cardiovascular disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischaemic Heart Desease, Cardiac Catheterization
- What is being tested?
- Virtual Reality Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2026to 30 Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adult patients (aged 18 years and above)
- Scheduled for first-time elective cardiac catheterization
- Able to understand Arabic or English
- Capable of providing informed consent
Who cannot join
- • Individuals with cognitive impairment or psychiatric conditions that may interfere with their ability to engage in the VR intervention
- Patients requiring emergency or urgent catheterization
About this study
Official title: Evaluating the Efficacy of Virtual Reality in Patient Preparation for Cardiac Catheterization Procedures in Oman: A Randomized Controlled Trial
Background: Cardiovascular disease is considered one of the most prevalent diseases in recent times, and cardiac catheterization is widely used to diagnose and treat cardiovascular disease. However, patients often experience significant anxiety before the procedure due to fear of the unknown, potential complications, and concern about discomfort.Aim: To evaluate the efficacy of virtual reality technology to reduce anxiety and improve patient satisfaction, attitude, and usefulness in individuals undergoing first-time cardiac catheterization procedures in Oman.Method: A mixed-method randomized control trial will be used with approximately 120 patients from different tertiary hospitals in Oman. The experimental group will experience a virtual reality simulation of the catheterization process before providing informed consent, while the control group will receive the standard pre-procedure education. The Arabic version of the DASS-21 scale will be used to assess anxiety level pre- and post-intervention, while patient satisfaction will be measured through qualitative interviews with a subset of 10 participants.Result: ANOVA will be conducted to examine differences in anxiety and satisfaction scores between groups, and Pearson's correlation (r) will assess relationships between anxiety levels and satisfaction scores, while paired t-tests will be applied to compare anxiety levels before and after the intervention within groups. Additionally, multiple regression analysis will be employed to identify predictors of patient satisfaction and anxiety reduction, with a significance level set at p ≤ 0.05 for all statistical tests.Conclusion: The expected outcome of this study is that virtual reality-based education will significantly reduce pre-procedure anxiety and enhance patient satisfaction compared to standard education. Findings from this research may contribute to improving patient-centered care and developing innovative strategies to optimize emotional preparedness before cardiac catheterization procedures.
- Being tested
- Virtual Reality Education
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality EducationBehavioural
Participants in this group will receive a virtual reality-based educational session prior to their first cardiac catheterization. The VR module provides an immersive 3D orientation to the catheterization process, including admission, preparation, transfer to the Cath Lab, procedural steps, and post-procedure recovery. The VR session lasts approximately 10-15 minutes and is delivered once in a quiet hospital setting before the scheduled procedure. This innovative approach aims to enhance patient understanding and reduce anxiety associated with the catheterization experience. By familiarizing participants with the entire process beforehand, the program seeks to improve overall satisfaction and outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Pre-procedure Education | Experimental | Participants in this group will receive a virtual reality-based educational session prior to their first cardiac catheterization. The VR module will provide a 3D immersive orientation to the catheterization process, including admission, preparation, transfer to the Cath Lab, procedural steps, and post-procedure recovery. The VR experience will last approximately 10-15 minutes and will be delivered once in a quiet setting within the hospital prior to the scheduled procedure. This innovative approach aims to reduce anxiety and enhance understanding of the procedure, ultimately improving patient outcomes. By familiarizing participants with the environment and steps involved, the program seeks to empower them and give them control over their healthcare experience. Receives: Behavioral: Virtual Reality Education |
| Standard Pre-procedure Education | No intervention | Participants in this group will receive the usual standard education provided at the hospital, which includes a verbal explanation by the nurse or physician and a written patient information leaflet describing the procedure, expected preparation, and recovery process. The session will last approximately 10-15 minutes and will be conducted prior to the scheduled procedure. During this time, participants will have the opportunity to ask questions and clarify any concerns they may have regarding their treatment. This interactive approach aims to enhance understanding and ensure that everyone feels confident and informed before proceeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pre-procedural anxiety (measured by DASS-21 Anxiety Subscale)
Anxiety will be assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21). The Anxiety subscale includes 7 items, each scored 0-3. Subscale scores are multiplied by 2, giving a final range of 0-42. Higher scores indicate greater anxiety.
Measured: Baseline (before intervention) to immediately prior to cardiac catheterization (within 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start5 Mar 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320248
- Sponsor's protocol ID
- 107/2025
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Virtual Reality in Patient Preparation for Cardiac Catheterization Procedures in Oman: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07320248
- Acronym / sponsor ID
- 107/2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jan 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.
Background: Cardiovascular disease is considered one of the most prevalent diseases in recent times, and cardiac catheterization is widely used to diagnose and treat cardiovascular disease. However, patients often experience significant anxiety before the procedure due to fear of the unknown, potential complications, and concern about discomfort.Aim: To evaluate the efficacy of virtual reality technology to reduce anxiety and improve patient satisfaction, attitude, and usefulness in individuals undergoing first-time cardiac catheterization procedures in Oman.Method: A mixed-method randomized control trial will be used with approximately 120 patients from different tertiary hospitals in Oman. The experimental group will experience a virtual reality simulation of the catheterization process before providing informed consent, while the control group will receive the standard pre-procedure education. The Arabic version of the DASS-21 scale will be used to assess anxiety level pre- and post-intervention, while patient satisfaction will be measured through qualitative interviews with a subset of 10 participants.Result: ANOVA will be conducted to examine differences in anxiety and satisfaction scores between groups, and Pearson's correlation (r) will assess relationships between anxiety levels and satisfaction scores, while paired t-tests will be applied to compare anxiety levels before and after the intervention within groups. Additionally, multiple regression analysis will be employed to identify predictors of patient satisfaction and anxiety reduction, with a significance level set at p ≤ 0.05 for all statistical tests.Conclusion: The expected outcome of this study is that virtual reality-based education will significantly reduce pre-procedure anxiety and enhance patient satisfaction compared to standard education. Findings from this research may contribute to improving patient-centered care and developing innovative strategies to optimize emotional preparedness before cardiac catheterization procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Pre-procedure Education | Experimental | Behavioral: Virtual Reality EducationParticipants in this group will receive a virtual reality-based educational session prior to their first cardiac catheterization. The VR module will provide a 3D immersive orientation to the catheterization process, including admission, preparation, transfer to the Cath Lab, procedural steps, and post-procedure recovery. The VR experience will last approximately 10-15 minutes and will be delivered once in a quiet setting within the hospital prior to the scheduled procedure. This innovative approach aims to reduce anxiety and enhance understanding of the procedure, ultimately improving patient outcomes. By familiarizing participants with the environment and steps involved, the program seeks to empower them and give them control over their healthcare experience. |
| Standard Pre-procedure Education | No intervention | –Participants in this group will receive the usual standard education provided at the hospital, which includes a verbal explanation by the nurse or physician and a written patient information leaflet describing the procedure, expected preparation, and recovery process. The session will last approximately 10-15 minutes and will be conducted prior to the scheduled procedure. During this time, participants will have the opportunity to ask questions and clarify any concerns they may have regarding their treatment. This interactive approach aims to enhance understanding and ensure that everyone feels confident and informed before proceeding. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Adult patients (aged 18 years and above)
Key exclusion criteria (2 listed)
- • Individuals with cognitive impairment or psychiatric conditions that may interfere with their ability to engage in the VR intervention
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 EducationParticipants in this group will receive a virtual reality-based educational session prior to their first cardiac catheterization. The VR module provides an immersive 3D orientation to the catheterization process, including admission, preparation, transfer to the Cath Lab, procedural steps, and post-procedure recovery. The VR session lasts approximately 10-15 minutes and is delivered once in a quiet hospital setting before the scheduled procedure. This innovative approach aims to enhance patient understanding and reduce anxiety associated with the catheterization experience. By familiarizing participants with the entire process beforehand, the program seeks to improve overall satisfaction and outcomes. | Behavioural | Virtual Reality Pre-procedure Education |
Primary outcome
Change in pre-procedural anxiety (measured by DASS-21 Anxiety Subscale)
Time frame: Baseline (before intervention) to immediately prior to cardiac catheterization (within 24 hours).
Anxiety will be assessed using the Depression, Anxiety and Stress Scale - 21 (DASS-21). The Anxiety subscale includes 7 items, each scored 0-3. Subscale scores are multiplied by 2, giving a final range of 0-42. Higher scores indicate greater anxiety.
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 6 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Education in people with Coronary Artery Disease and Ischaemic Heart Desease, run by Sultan Qaboos University.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 pre-procedural anxiety (measured by DASS-21 Anxiety Subscale) (time frame: Baseline (before intervention) to immediately prior to cardiac catheterization (within 24 hours).). 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 6 Jan 2026.