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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04651075
Other study ID # AIBU-HSF-AYN-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date April 1, 2019

Study information

Verified date April 2022
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography.


Description:

The aim of this study was to investigate the effects of education and music listening on the anxiety and physiological parameters experienced by individuals undergoing elective coronary angiography. The population of the study consisted of individuals undergoing elective coronary angiography in the Cardiology Department of Abant İzzet Baysal University İzzet Baysal Training and Research Hospital. The study was conducted in a randomized controlled manner with three groups: 34 individuals in music listening group (M1), 34 individuals in information training group (M2) and 34 subjects in control group. In order to collect data, CAG (Coronary angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale and Spielberg State and Trait Anxiety Scale were used. Data were collected by face to face interview technique. Descriptive statistics, Independet Simple test, Paired sample t test, Kruskall Wallis, Mann Whitney U test and Wilcoxon signed rank test were used in the analysis of the data and the significance level was accepted as p <0.05.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Applying femoral CAG electively, - The first time CAG will be held, - Performing the CAG procedure for diagnostic purposes, - Not trained on the CAG process, - Volunteering to participate in the study, - No problem in verbal communication, - No hearing loss, - Being able to read and write, - Has not been diagnosed with psychiatric illness, - Being conscious, - Being 18 or older. Exclusion Criteria: Radial application of CAG, - Previously performing coronary angiography, - Performing the CAG procedure for therapeutic purposes (stent, balloon, etc.), - Having received training on the KAG process, - Does not want to participate in the study - Problems in verbal communication, - Hearing loss, - Psychiatric illness is found. - Consciousness is closed.

Study Design


Intervention

Other:
music listening
The music selected by the participants was played to the music listening group.
individual training
Individual training group was trained on coronary angiography.

Locations

Country Name City State
Turkey Abant Izzet Baysal University Bolu Merkez

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other means of blood pressure (mmHg) In the study, a digital sphygmomanometer, which has been calibrated in comparison with the mercury sphygmomanometer, is used in order to prevent individual differences in the measurement of blood pressure. For accurate results, the sphygmomanometer sleeve is sized for adult individuals (width = about 20 cm, length = about 40 cm). In order for the blood pressure not to be affected by the conditions during the measurement, it is taken into account that the individual did not drink tea or coffee, take caffeine, and preferably did not eat during the 30 minutes prior to measurement. up to 45 minutes
Other means of heart rate (/min) The heart rate is the pressure of the left ventricle on the vascular wall of the blood that it throws into the aorta during systole from the skin surface.In the research, radial heart rate is measured as manuel. up to 45 minutes
Other means of respiratory rate (/min) The respiratory rate is the patient's breath per minute. In this study, respiratory rate was counted by monitoring chest movements for one minute while the patient was in a sitting position. up to 45 minutes
Primary means of subjective anxiety scores Spielberg State- Trait Anxiety Scale. The total score between 0-19 obtained from the state anxiety scale shows that there is no anxiety, the total score between 20-39 indicates mild, the average score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety, and over 60 points are needed for professional help. The scores obtained from the trait anxiety scale vary between 20 and 80. A high score means a high and a low level means anxiety. up to 45 minutes
Secondary means of subjective pain scores visual analog scale. It consists of a straight line with endpoints that define end limits such as "no pain" and "pain as bad as possible". The patient is asked to mark the level of pain on the line between the two endpoints. up to 45 minutes
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