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Music Listenıng And Training Before Coronary Angıography

Primary Purpose

Coronary Artery Disease, Anxiety, Music

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music listening
individual training
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Coronary Angiography, Teaching, Music theraphy, Anxiety, Nursing care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Abant İzzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

music theraphy

information education

nursing care

Arm Description

One of the 4 music genres (Turkish Folk, Classical, Turkish Art and Sufi Music), which was determined by the researcher by scanning the literature 30 minutes before the CAG procedure, and the expert opinion was taken to the participants in this group was played with a 5-minute headset. The musical genres were arranged in instrumental, nonverbal, 70 decibels in terms of rhythm and duration and played according to the individual's choice.

Participants in this group were trained to inform them about CAG in visual, audio and written form. Information training was provided by the researcher 30 minutes before the CAG procedure after the outpatient clinic controls of the patient. Information education prepared by the researcher by scanning the literature and getting expert opinion; It includes 7 minutes of video explanation about the CAG process, discussion after video watching, question and answer, and the delivery of a training book prepared in written form.

Individuals in this group received routine nursing care and no intervention was made by the researcher. In routine nursing care for individuals who will receive CAG procedure in the clinic; Preparation for the CAG procedure, which involves opening the vascular access and dressing the surgical gown, is included in the pre-and post-procedure routine once and more frequently when there are deviations from normal, and if the patient asks questions about the procedure, measurement of blood pressure, heart rate and oxygen saturation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2020
Last Updated
April 20, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04651075
Brief Title
Music Listenıng And Training Before Coronary Angıography
Official Title
Effects On Physıological Parameters And Anxiety Of Related Musıc And Informatıon Training Before Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Anxiety, Music, Education
Keywords
Coronary Angiography, Teaching, Music theraphy, Anxiety, Nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 3 groups as intervention and control
Masking
Participant
Masking Description
the participant did not know which group he was in.
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music theraphy
Arm Type
Experimental
Arm Description
One of the 4 music genres (Turkish Folk, Classical, Turkish Art and Sufi Music), which was determined by the researcher by scanning the literature 30 minutes before the CAG procedure, and the expert opinion was taken to the participants in this group was played with a 5-minute headset. The musical genres were arranged in instrumental, nonverbal, 70 decibels in terms of rhythm and duration and played according to the individual's choice.
Arm Title
information education
Arm Type
Experimental
Arm Description
Participants in this group were trained to inform them about CAG in visual, audio and written form. Information training was provided by the researcher 30 minutes before the CAG procedure after the outpatient clinic controls of the patient. Information education prepared by the researcher by scanning the literature and getting expert opinion; It includes 7 minutes of video explanation about the CAG process, discussion after video watching, question and answer, and the delivery of a training book prepared in written form.
Arm Title
nursing care
Arm Type
No Intervention
Arm Description
Individuals in this group received routine nursing care and no intervention was made by the researcher. In routine nursing care for individuals who will receive CAG procedure in the clinic; Preparation for the CAG procedure, which involves opening the vascular access and dressing the surgical gown, is included in the pre-and post-procedure routine once and more frequently when there are deviations from normal, and if the patient asks questions about the procedure, measurement of blood pressure, heart rate and oxygen saturation.
Intervention Type
Other
Intervention Name(s)
music listening
Intervention Description
The music selected by the participants was played to the music listening group.
Intervention Type
Other
Intervention Name(s)
individual training
Intervention Description
Individual training group was trained on coronary angiography.
Primary Outcome Measure Information:
Title
means of subjective anxiety scores
Description
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.
Time Frame
up to 45 minutes
Secondary Outcome Measure Information:
Title
means of subjective pain scores
Description
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.
Time Frame
up to 45 minutes
Other Pre-specified Outcome Measures:
Title
means of blood pressure (mmHg)
Description
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.
Time Frame
up to 45 minutes
Title
means of heart rate (/min)
Description
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.
Time Frame
up to 45 minutes
Title
means of respiratory rate (/min)
Description
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.
Time Frame
up to 45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Abant İzzet Baysal University
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14100_
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Music Listenıng And Training Before Coronary Angıography

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