The Effect of Virtual Reality on Patient Outcome

NCT ID: NCT07138430

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Virtual Reality Coronary Angiography (CAG)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled experimental study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

In this study, patients in the intervention group were informed about the coronary angiography procedure and the virtual reality application.

Group Type EXPERIMENTAL

intervention group

Intervention Type OTHER

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.

Control Group

Patients in this group received no other interventions during the coronary angiography procedure other than standard care and treatment.

Group Type PLACEBO_COMPARATOR

standard care and treatment.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intervention group

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who have difficulty using virtual reality glasses and who experience headaches, nausea, and vomiting
* Patients under the age of 18
* Pregnant patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

HARUN ÜNAL

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

HARUN ÜNAL

investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Van YYÜ Univercity

Van, Van, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1903

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Virtual Reality
NCT07283172 NOT_YET_RECRUITING NA