Vırtual Reality and Music in Coronary Angiography

August 30, 2025 updated by: HARUN ÜNAL

Distractional Interventions on Patients' Anxiety, Pain and Physiological Parameters Durıng Coronary Angiography: The Effect of Virtual Reality and Music

"Coronary The scope of this study, which was conducted for the purpose of "Distracting Interventions on Patients' Anxiety, Pain and Physiological Parameters During Angiography: The Effect of Virtual Reality and Music", is to help patients at the level of evidence during coronary angiography and to contribute to the literature.

Study Overview

Status

Completed

Detailed Description

Before starting the application, patients who meet the criteria for inclusion in the study will be determined according to the randomization order and information about the study will be given.

Patients will be randomly assigned to the control and intervention groups (virtual reality and music group). Then, the following interventions will be applied sequentially, depending on the group the patient is included in.

After the appropriate participants are determined, written informed consent will be given to the participants and the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied just before the procedure begins, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form. Later patients will undergo coronary angiography. For the control group, conventional procedures will be applied by the researcher and medical care staff.

Patients in the virtual reality group, one of the intervention groups, will be shown a video with predetermined relaxing visuals and sounds through virtual reality glasses. Before watching the video, the researcher informed about the use of virtual reality glasses.

The patient will be informed. They will use the SG glasses for 3-5 minutes before the procedure begins for the patient to get used to it, and then the procedure will begin. VR glasses will be kept on throughout the procedure. In addition, the patient is advised at any stage of the application.

He will be told that he can remove his glasses and withdraw from the study. USB MP3 players and headphones will be provided by the researcher to collect data for the music group. Various styles of music (Classical World Music, Popular Music, Classical Turkish Music, Sufi Music) will be loaded into the USB MP3 player. Patients will be able to choose any of these music styles from the folder and listen to them. Music group patients from the intervention groups will be informed before starting the procedure and will be given 3-5 minutes.

MP3 reader and headphones will be provided throughout. Then, the patient will be taken to the coronary angiography procedure and will be allowed to listen to the previously prepared music of the patient's choice throughout the procedure.

Physiological parameters of patients during coronary angiography will be measured. After the procedure is completed, the Patient Introduction Form, State Anxiety Scale and Visual Comparison Scale will be applied to the patients in all three groups, and then the patient's physiological parameters will be measured and recorded in the Patient Monitoring Form.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • tuşba
      • Van, tuşba, Turkey (Türkiye), 65100
        • Van Yuzuncu Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Between the ages of 18-70, Patients who agreed to participate in the study voluntarily, Open to communication, Knows how to read and write, Patients without visual or auditory impairments, Patients who underwent femoral artery area intervention, Patients who are administered opioid and tranquilizer derivative drugs, Patients who were undergoing coronary angiography for the first time were included in the study.

Exclusion Criteria:

Having difficulty using virtual reality glasses, Patients with headache, nausea and vomiting were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality
Patients were fitted with virtual reality glasses.
Virtual reality application were applied to patients during coronary angiography.
Experimental: music
Patients were listened to music
Patients will listen to music during coronary angiography.
No Intervention: control
Patients were not interfered with and were receive standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Identification Form
Time Frame: 10 minutes
This form, prepared by researchers based on literature reviews, consists of a total of 13 questions to question the socio-demographic characteristics of patients and their disease-related characteristics.
10 minutes
Visual Analog Scale
Time Frame: 10 minutes
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
Time Frame: 10 minutes
The study used the "State and Trait Anxiety Scale," developed by Spielberger et al. (1970) and translated and adapted into Turkish by Oner 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 in a given moment. The second section includes the "Trait Anxiety Scale," which also includes statements about how a person generally feels. This study was designed for use during coronary angiography, and the "State Anxiety Scale" was used based on literature research and expert opinions.
10 minutes
Patient Follow-up Form
Time Frame: 10 minutes
This is a form created by researchers to record the physiological parameters (heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, oxygen saturation) measured by researchers before (manually), during (digitally via a femoral catheter), and after the procedure (digitally via a femoral catheter). The measurements taken from the patient were recorded on this form.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Harun ÜNAL, phd student, Ataturk Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

December 2, 2024

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

August 5, 2025

First Posted (Actual)

August 12, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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