Effect of Information Given and Music on the Care of Patient Who Will Undergo Coronary Angiography

NCT ID: NCT04276506

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-10
• Study Completion Date: 2020-03-10

Brief Summary

Today, due to the increasing frequency of cardiovascular diseases the number of coronary angiography performed has also risen. This invasive procedure has an effect on patients which causes anxiety. Its important to determine of the level of anxiety so experienced nurses carried out various interventions to reduce anxiety.

This study aims to determine the effect of listening music and getting information on the level of anxiety and vital signs of the patients who are planned to undergo coronary angiography.

For this purpose, calming music which is suitable for the heart rhythm and booklets which is prepared with various visuals will be used. In the study, apart from a control group that routine clinical procedures will be applied, there will be two more groups which are called as music and information groups. Patients' participation in these groups will be distributed randomly by computer.

Detailed Description

The patients will be included to this study who will undergo coronary angiography first time and admitted to hospital by appointment.

Inserting IV canulla, taking and recording vital signs, and informing about angiography are routine procedures for patients who are admitted to hospital for coronary angiography. These procedures will also be applied to the patient groups involved in the study.

Patients will be assigned to the groups in accordance with the randomization table. After explaining the purpose and method of the study to the patients, their consent will be obtained.In this experimental study all datas will be collected by Descriptive Characteristics Form, Vital Findings Follow-Up Form and The State-Continuity Anxiety Inventory.

Vital Signs Follow-Up Form will be recorded according to patients' findings, such as heart rate per minute, blood pressure as mmHg and respiratory rate per minute both before and after angiography.

The State-Continuity Anxiety Inventory will be applied before angiography to determine the anxiety level of the patients. After the angiography, the state anxiety inventory will be repeated.The information group; A visual information booklet which is prepared by the researcher will be used. In the booklet; Information about coronary arteries, angiography laboratory features, patient preparation procedure and post-procedure are explained with various visuals. The booklet which contains researchers telephone numbers will be given to patients, when they come to hospital to get an angiography appointment. The patients will be asked to read the booklet until the day of angiography. If patients need to ask some questions, they will be able to reach the researchers within specified hours.

The Music group; A soothing type of music including five kinds sounds of nature which suitable for heart rate was selected and recorded on MP3. When they arrive hospital for angiography they will be explained how to use MP3 player and headset in the room. All music stored on the MP3 player will be played to the patient for five to ten seconds. They will be asked to choose their preferred music. The patient will listen the music which is chosen for 30 minutes via headset. In order to prevent contamination, disposable ear cups will be used for each patient.

Conditions

Anxiety State; Invasive Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

information booklet group

information session before the coronary angiography

Group Type: EXPERIMENTAL

information group

Intervention Type: OTHER

A visual information booklet which is prepared by the researchers will be used

music group

music session before the coronary angiography

Group Type: EXPERIMENTAL

music group

Intervention Type: OTHER

to reduce anxiety, some selected music pieces will have patients listened by headset.

control group

No information or music session before the coronary angiography

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

music group

to reduce anxiety, some selected music pieces will have patients listened by headset.

Intervention Type: OTHER

information group

A visual information booklet which is prepared by the researchers will be used

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adult
• patients who undergoing coronary angiography first time
• able to speak and understand turkish
• people informed clearly by the investigator

Exclusion Criteria

• having any hearing and visual problems
• being on psychiatric medications
• emergency cases
• patient under legally protection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Handan Sezgin, Assist Prof.

Role: STUDY_DIRECTOR

Eastern Mediterranean University Health Science Faculty

Nurdan Yıldız, Msc

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University Health Science Faculty

Locations

EMU Health Science Faculty

Famagusta, , Cyprus

Countries

Cyprus

Other Identifiers

EasternMUU

Identifier Type: -

Identifier Source: org_study_id