- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276506
Effect of Information Given and Music on the Care of Patient Who Will Undergo Coronary Angiography
Comparison of the Effect of Music and Giving Information on the Patient Care Who Undergoing Coronary Angiography
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Famagusta, Cyprus, 99628
- EMU Health Science Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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: information booklet group
information session before the coronary angiography
|
A visual information booklet which is prepared by the researchers will be used
|
Experimental: music group
music session before the coronary angiography
|
to reduce anxiety, some selected music pieces will have patients listened by headset.
|
No Intervention: control group
No information or music session before the coronary angiography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State anxiety level
Time Frame: 1 day
|
Use of the State-Trait Anxiety Inventory (STAI) to assess the level of anxiety
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
heart rate
Time Frame: 1 day
|
beats per minute
|
1 day
|
respiratory rate
Time Frame: 1 day
|
breaths per minute
|
1 day
|
blood pressure
Time Frame: 1 day
|
mmHg
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Handan Sezgin, Assist Prof., Eastern Mediterranean University Health Science Faculty
- Principal Investigator: Nurdan Yıldız, Msc, Eastern Mediterranean University Health Science Faculty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EasternMUU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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