Virtual Reality for Patient Preparation Before Cardiac Catheterization in Oman

NCT07320248 | Not Yet Recruiting DMC

• 1 other identifier: 107/2025
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Ischaemic Heart Desease; Cardiac Catheterization; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (before intervention) to immediately prior to cardiac catheterization (within 24 hours).

Study Arms (2)

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.

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.

Interventions

Virtual Reality Education BEHAVIORAL

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.

Virtual Reality Pre-procedure Education

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and care providers will be aware of group allocation due to the nature of the intervention. However, the outcomes assessor analyzing the questionnaire data will be blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: January 6, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-09