Effect of Music on Coronary Angiography

December 23, 2024 updated by: Özlem Canbolat

Effect of Music on Comfort, Anxiety and Hemodynamic Parameters During Coronary Angiography

This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Ankara, Turkey
        • Gazi 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 18 years of age or older
  • Being at least literate
  • Having no mental and cognitive competence
  • Understanding and speaking Turkish
  • Having a planned coronary angiography
  • Performing for diagnostic purposes

Exclusion Criteria:

  • Having visual and hearing impairment
  • Having a psychiatric diagnosis
  • Using psychiatric medication (tranquilizers, etc.)
  • Using anxiety medication in the last 6 months
  • Having had coronary angiography before
  • The coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.)
  • An unexpected complication during coronary angiography (arrhythmia, MI, bleeding, etc.)
  • coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure
  • Data collection forms were not filled out by the participant after coronary angiography

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Application Group
After explaining the purpose of the study and the way it was applied to patients in the music group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. The intervention group listened to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.Music was played to the intervention group via a loudspeaker placed in the coronary angiography laboratory.The intervention group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure.
Other: listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music
Listening to nature sounds (the sound of birds, water flowing in a river, wind or walking in the forest) based music during the angiography procedure.
No Intervention: Control Group
After explaining the purpose of the study and the way it was applied to patients in the control group, Introductory Information Form, State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form were applied. No application was be made to the control group. The control group was reapplied the State Anxiety Scale, General Comfort Scale and Hemodynamic Parameters Record Form after the angiography procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
General Comfort Scale
Time Frame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Scores from the scale range from 48 to 192, and the higher the score, the higher the comfort level.
before the angiography procedure and after the angiography procedure (average of 15 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
State Anxiety Scale
Time Frame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Scores from the scale range from 20 to 80, and the higher the score, the higher the anxiety level.
before the angiography procedure and after the angiography procedure (average of 15 minutes)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemodynamic Parameters Record Form
Time Frame: before the angiography procedure and after the angiography procedure (average of 15 minutes)

The form was used to record the Systolic Blood Pressure (mm/Hg), Diastolic Blood Pressure (mm/Hg), Respiratory Rate, Heart Rate (Pulse) (atm/min) and Saturation parameters measured before and after the angiography procedure of the intervention and control groups.

Systolic blood pressure measurements were averaged. Diastolic blood pressure measurements were averaged. Saturation measurements were averaged. Respiratory rate measurements were averaged. Heart Rate (Pulse) measurements were averaged.
before the angiography procedure and after the angiography procedure (average of 15 minutes)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Özlem Canbolat

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-77082166-302.08.01-850481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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