NCT07117838

Brief Summary

"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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

March 26, 2025

Last Update Submit

August 30, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Patient Identification Form

    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

    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

    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

    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

Study Arms (3)

virtual reality

EXPERIMENTAL

Patients were fitted with virtual reality glasses.

Other: virtual reality

music

EXPERIMENTAL

Patients were listened to music

Other: music

control

NO INTERVENTION

Patients were not interfered with and were receive standard care.

Interventions

Virtual reality application were applied to patients during coronary angiography.

virtual reality
musicOTHER

Patients will listen to music during coronary angiography.

music

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University

Van, tuşba, 65100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Harun ÜNAL, phd student

    ataturk universty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One count for 120 patients who met the study's inclusion criteria A list will be created and patients will be distributed to experimental and intervention groups with a computerized randomization program (https://www.random.org/integer-sets/). According to the randomization result, patients will be assigned to the virtual reality group (intervention 1), the music group (intervention 2) and the control group (Control) with standard treatment. All patients will be randomized to the intervention and control groups after being admitted to the angiography unit. - It will be named as intervention group (the group to which virtual reality glasses and music will be applied) and - Control group (the group to which no additional procedure will be applied to the standard care during the coronary angiography procedure).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 26, 2025

First Posted

August 12, 2025

Study Start

April 8, 2024

Primary Completion

December 2, 2024

Study Completion

December 2, 2024

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations