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Completed

NCT Number: NCT07117838

Vırtual Reality and Music in Coronary Angiography

"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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yuzuncu Yil University

Van, tuşba, 65100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality

Other

Virtual reality application were applied to patients during coronary angiography.

Music

Other

Patients will listen to music during coronary angiography.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

HARUN ÜNAL

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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