NCT07138430

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 24, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

Coronary AngiographyVirtual RealityNursing

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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).

    5 minutes

Study Arms (2)

intervention group

EXPERIMENTAL

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

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.

Other: standard care and treatment.

Interventions

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 group

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.

Control Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van YYÜ Univercity

Van, Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Standard of CareTherapeutics

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 22, 2025

Study Start

March 1, 2025

Primary Completion

August 8, 2025

Study Completion

August 30, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations