Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04806204
Status:
UNKNOWN
Last Update Posted:
2021-09-30
First Post:
2021-01-27
Brief Title:
Music Therapy in Coronary Angiography
Sponsor:
Abant Izzet Baysal University
Organization:
Abant Izzet Baysal University
Study Overview
Official Title:
Effect of Music Therapy on Pain Anxiety and Vital Signs Before and During Coronary Angiography
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim This study was planned as randomized controlled to determine the effect of music therapy applied before and during angiography on pain anxiety and physiological parameters after angiography
The study was planned as a pre-test post-test design single center randomized controlled experimental studyThe study is planned to be conducted in the coronary angiography CAG unit of a university hospital between January 2021 and December 2021 the study sample will be composed of a total of 102 individuals 34 in each group intervention 1 group listening to music before the procedure 34 intervention 2 group listening to music during the procedure 34 control group 34Data in the research The Introductory Form will be collected using the State-Trait Anxiety Scale Vital Signs Follow-up Form and Visual Pain Scale VASPatients in the Intervention 1 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played with headphones for 15-20 minutes before the CAG procedurePatients in the Intervention 2 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played through a speaker that will be placed in the angiography hall during the CAG procedure Routine care will be applied to patients in this group and music therapy will not be applied
The study was planned as a pre-test post-test design single center randomized controlled experimental studyThe study is planned to be conducted in the coronary angiography CAG unit of a university hospital between January 2021 and December 2021 the study sample will be composed of a total of 102 individuals 34 in each group intervention 1 group listening to music before the procedure 34 intervention 2 group listening to music during the procedure 34 control group 34Data in the research The Introductory Form will be collected using the State-Trait Anxiety Scale Vital Signs Follow-up Form and Visual Pain Scale VASPatients in the Intervention 1 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played with headphones for 15-20 minutes before the CAG procedurePatients in the Intervention 2 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played through a speaker that will be placed in the angiography hall during the CAG procedure Routine care will be applied to patients in this group and music therapy will not be applied
Detailed Description:
It is predicted that music therapy will be beneficial before and during angiography in order to prevent complications reduce anxiety and pain and provide patient comfort and satisfaction This study was planned as randomized controlled to determine the effect of music therapy applied before and during angiography on pain anxiety and physiological parameters after angiography
Material - Method Research design The study was planned as a pre-test post-test design single center randomized controlled experimental study
Place and Time of the Study The study is planned to be conducted in the coronary angiographyCAG unit of a university hospital between January 2021 and December 2021
Population and sampling The population of the study consists of patients who will undergoing CAG between January 2021 and December 2021 No special method is used for sample selection individuals who are treated on the specified dates who meet the inclusion criteria and who volunteer to participate in the study will be included in the sample Power analysis will be done to determine the sample size The sample of the study will be composed of individuals who meet the inclusion criteria of the study within the time that the study is planned As a result of the literature review the number of samples for each group was found to be 28 at a significance level of α 005 and a power of 80 in randomized controlled studies with CAG However considering that there may be losses in the implementation phase of the study provided that the individuals who will be treated with CAG are included 20 more of these numbers in each group will be included in the study Thus the study sample will be composed of a total of 102 individuals 34 in each group intervention 1 group listening to music before the procedure 34 intervention 2 group listening to music during the procedure 34 control group 34 In addition while the application of the study continues the data obtained will be transferred to the computer program and it will be evaluated whether the sufficient sample number has been reached by power analysis
Data Collection Tools Data in the research The Introductory Form will be collected using the State-Trait Anxiety Scale Vital Signs Follow-up Form and Visual Pain Scale
Patient Information Form This form consists of 17 questions in order to determine the personal information of the patients age gender occupation educational status marital status people living with them income level smoking-alcohol use family angiography history social security etc
State-Trait Anxiety Scale The original of this scale was developed by Spielberger et al In 1970 to determine the level of anxiety It consists of two parts as State and Trait Anxiety Scale
State Anxiety Scale It is a 4-point Likert type scale consisting of 20 questions aiming to measure how individuals feel at the moment The scores obtained from the scale vary between 20 and 80 and a high score indicates that anxiety is high and a low score indicates that anxiety level is low The adaptation to the Turkish form was made by Öner and Le Compte In the state anxiety scale There are two types of expressions direct expressions expressing negative feelings and inverted statements expressing positive feelings The expressions to be scored in reverse in the State Anxiety Scale are items 1 2 5 8 10 11 15 16 19 and 20 While these items are scored those with 1 weight value are converted to 4 and those with 4 weight values are converted into 1 and the score is calculated A total score of 0-19 from the scale indicates that there is no anxiety the total score between 20-39 indicates mild the total score between 40-59 indicates moderate and the total score between 60-79 indicates severe anxiety while 60 points above indicate the need for professional help Test-retest reliability of the scale was found between 016 and 054
Trait Anxiety Scale Indicates how the person feels regardless of the situation and conditions Scores from each scale range between 20 and 80 A high score means high and a low score means a low level of anxiety The same is true when interpreting the scores in order of percentage That is a low percentage 1 5 10 shows that anxiety is low The average score level determined in the applications varies between 36 and 41 0-30 indicates low anxiety 31-49 indicates moderate anxiety and 50 and above indicate high anxiety The expressions with reverse scoring on the Spielberg Trait Anxiety Scale are 1 6 7 10 13 16 19 Test-retest reliability was found between 073 and 086
Vital Signs Follow-up Form This form It was prepared with the aim of recording body temperature pulse blood pressure oxygen saturation and respiratory values from vital signs of the individual measured before and after the procedure The vital signs of the patients measured by the clinical nurses before and after the procedure and recorded on the nurse observation form will be recorded in the vital signs follow-up form by the investigators
Visual Pain Scale Visual analog scale was used to evaluate the pain It consists of a straight line with endpoints defining the extremes such as no pain and pain as bad as possible The patient is asked to mark the pain level on the line between the two end points This tool was first used in psychology by Freyd in 1923 Kersten et al Proved in their study that VAS is a valid tool for pain assessment This results in accordance with Unsal and Ergül vase 29 rate in their study has determined that it is being used in studies in Turkey The horizontal form of VAS will be used in the assessment of pain in our study
Data Collection Individuals meeting the inclusion criteria in data collection will be randomized into 3 groups Individuals who meet the inclusion criteria in the study will be randomized in a computer program and divided into intervention group 1 intervention group 2 and control group Individuals undergoing elective angiography will be included in the groups according to their arrival order In the randomization table the first column represents the intervention 1 group the second column represents the intervention 2 group and the third column represents the control group Patients who meet the inclusion criteria will be included in the group in which column they are included in the order of arrival
Intervention 1 Group After the polyclinic controls of the patients on the day of the CAG procedure data collection forms will be applied in the CAG unit 30 minutes before the procedure Patients in the Intervention 1 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played with headphones for 15-20 minutes before the CAG procedure Since individuals are in the CAG unit collectively before the procedure headphones will be used in order not to disturb other individuals In determining the music to be played literature was searched and expert opinion was obtained from the academicians of Fine Arts Education Department Music Department After the interviews musical types will be arranged as instrumental non-verbal at 70 decibels approximately 60 metronome per minute in terms of rhythm and duration and will be played according to the individuals choice Instrumental works will be uploaded to the portable MP3 player provided by the researchers The patients in the Intervention 1 group will be introduced to the MP3 player before the procedure and how they should use it and the questions of the patients will be answered After the patients who are taken to the CAG unit for the CAG procedure are prepared for the operation the patients will be told to imagine that the outcome of the procedure will be positive headphones will be worn and music therapy will be started In addition patients will be informed that they can interfere with the sound of the music turn the sound on and off stop the music and start listening again if they wish The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure and data collection forms will be applied again after 20 minutes
Intervention 2 Group After the polyclinic controls of the patients on the day of the angiography procedure data collection forms will be applied in the angiography unit 30 minutes before the procedure Patients in the Intervention 2 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played through a speaker that will be placed in the CAG hall during the CAG procedure In determining the music to be played literature was searched and expert opinion was obtained from the academicians of Fine Arts Education Department Music Department After the interviews musical types will be arranged as instrumental non-verbal 75 decibels approximately 60 metronome per minute in terms of rhythm and duration and will be played according to the individuals choice The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure and data collection forms will be applied again after 20 minutes
Control Group After the polyclinic controls of the patients on the day of the aCAG procedure data collection forms will be applied in the angiography unit 30 minutes before the procedure Routine care will be applied to patients in this group and music therapy will not be applied The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure and data collection forms will be applied again 20 minutes later
Ethical considerations Ethical approval will be obtained from the Bolu Abant İzzet Baysal University Clinical Research Ethics Committee in order to conduct the study Institutional permission will be obtained from Izzet Baysal Training and Research Hospital where the study will be conducted In addition before starting the application written consent will be obtained by the researcher explaining the purpose of the study to those who meet the inclusion criteria of the study
Data analysis In evaluating the data the significance level was taken as p 005 and the data will be analyzed using the SPSS 2500 program In the evaluation of the data besides descriptive statistical methods frequency percentage and average Independent Samples Unrelated samples t test will be used for intergroup comparisons of parameters showing normal distribution and related samples t test will be used for intragroup comparisons In the intergroup comparisons of non-normally distributed parameters Kruskall Wallis will be used to determine the significant difference of variables with more than three subcategories the Mann Whitney U will be used to determine the group that causes the difference and the Wilcoxon signed rank test for the same group data will be used for intragroup comparisons of non-normally distributed parameters
Material - Method Research design The study was planned as a pre-test post-test design single center randomized controlled experimental study
Place and Time of the Study The study is planned to be conducted in the coronary angiographyCAG unit of a university hospital between January 2021 and December 2021
Population and sampling The population of the study consists of patients who will undergoing CAG between January 2021 and December 2021 No special method is used for sample selection individuals who are treated on the specified dates who meet the inclusion criteria and who volunteer to participate in the study will be included in the sample Power analysis will be done to determine the sample size The sample of the study will be composed of individuals who meet the inclusion criteria of the study within the time that the study is planned As a result of the literature review the number of samples for each group was found to be 28 at a significance level of α 005 and a power of 80 in randomized controlled studies with CAG However considering that there may be losses in the implementation phase of the study provided that the individuals who will be treated with CAG are included 20 more of these numbers in each group will be included in the study Thus the study sample will be composed of a total of 102 individuals 34 in each group intervention 1 group listening to music before the procedure 34 intervention 2 group listening to music during the procedure 34 control group 34 In addition while the application of the study continues the data obtained will be transferred to the computer program and it will be evaluated whether the sufficient sample number has been reached by power analysis
Data Collection Tools Data in the research The Introductory Form will be collected using the State-Trait Anxiety Scale Vital Signs Follow-up Form and Visual Pain Scale
Patient Information Form This form consists of 17 questions in order to determine the personal information of the patients age gender occupation educational status marital status people living with them income level smoking-alcohol use family angiography history social security etc
State-Trait Anxiety Scale The original of this scale was developed by Spielberger et al In 1970 to determine the level of anxiety It consists of two parts as State and Trait Anxiety Scale
State Anxiety Scale It is a 4-point Likert type scale consisting of 20 questions aiming to measure how individuals feel at the moment The scores obtained from the scale vary between 20 and 80 and a high score indicates that anxiety is high and a low score indicates that anxiety level is low The adaptation to the Turkish form was made by Öner and Le Compte In the state anxiety scale There are two types of expressions direct expressions expressing negative feelings and inverted statements expressing positive feelings The expressions to be scored in reverse in the State Anxiety Scale are items 1 2 5 8 10 11 15 16 19 and 20 While these items are scored those with 1 weight value are converted to 4 and those with 4 weight values are converted into 1 and the score is calculated A total score of 0-19 from the scale indicates that there is no anxiety the total score between 20-39 indicates mild the total score between 40-59 indicates moderate and the total score between 60-79 indicates severe anxiety while 60 points above indicate the need for professional help Test-retest reliability of the scale was found between 016 and 054
Trait Anxiety Scale Indicates how the person feels regardless of the situation and conditions Scores from each scale range between 20 and 80 A high score means high and a low score means a low level of anxiety The same is true when interpreting the scores in order of percentage That is a low percentage 1 5 10 shows that anxiety is low The average score level determined in the applications varies between 36 and 41 0-30 indicates low anxiety 31-49 indicates moderate anxiety and 50 and above indicate high anxiety The expressions with reverse scoring on the Spielberg Trait Anxiety Scale are 1 6 7 10 13 16 19 Test-retest reliability was found between 073 and 086
Vital Signs Follow-up Form This form It was prepared with the aim of recording body temperature pulse blood pressure oxygen saturation and respiratory values from vital signs of the individual measured before and after the procedure The vital signs of the patients measured by the clinical nurses before and after the procedure and recorded on the nurse observation form will be recorded in the vital signs follow-up form by the investigators
Visual Pain Scale Visual analog scale was used to evaluate the pain It consists of a straight line with endpoints defining the extremes such as no pain and pain as bad as possible The patient is asked to mark the pain level on the line between the two end points This tool was first used in psychology by Freyd in 1923 Kersten et al Proved in their study that VAS is a valid tool for pain assessment This results in accordance with Unsal and Ergül vase 29 rate in their study has determined that it is being used in studies in Turkey The horizontal form of VAS will be used in the assessment of pain in our study
Data Collection Individuals meeting the inclusion criteria in data collection will be randomized into 3 groups Individuals who meet the inclusion criteria in the study will be randomized in a computer program and divided into intervention group 1 intervention group 2 and control group Individuals undergoing elective angiography will be included in the groups according to their arrival order In the randomization table the first column represents the intervention 1 group the second column represents the intervention 2 group and the third column represents the control group Patients who meet the inclusion criteria will be included in the group in which column they are included in the order of arrival
Intervention 1 Group After the polyclinic controls of the patients on the day of the CAG procedure data collection forms will be applied in the CAG unit 30 minutes before the procedure Patients in the Intervention 1 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played with headphones for 15-20 minutes before the CAG procedure Since individuals are in the CAG unit collectively before the procedure headphones will be used in order not to disturb other individuals In determining the music to be played literature was searched and expert opinion was obtained from the academicians of Fine Arts Education Department Music Department After the interviews musical types will be arranged as instrumental non-verbal at 70 decibels approximately 60 metronome per minute in terms of rhythm and duration and will be played according to the individuals choice Instrumental works will be uploaded to the portable MP3 player provided by the researchers The patients in the Intervention 1 group will be introduced to the MP3 player before the procedure and how they should use it and the questions of the patients will be answered After the patients who are taken to the CAG unit for the CAG procedure are prepared for the operation the patients will be told to imagine that the outcome of the procedure will be positive headphones will be worn and music therapy will be started In addition patients will be informed that they can interfere with the sound of the music turn the sound on and off stop the music and start listening again if they wish The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure and data collection forms will be applied again after 20 minutes
Intervention 2 Group After the polyclinic controls of the patients on the day of the angiography procedure data collection forms will be applied in the angiography unit 30 minutes before the procedure Patients in the Intervention 2 group will be offered Turkish Folk Classical Turkish Art and Sufi Music as an option and the music preferred by the patients will be played through a speaker that will be placed in the CAG hall during the CAG procedure In determining the music to be played literature was searched and expert opinion was obtained from the academicians of Fine Arts Education Department Music Department After the interviews musical types will be arranged as instrumental non-verbal 75 decibels approximately 60 metronome per minute in terms of rhythm and duration and will be played according to the individuals choice The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure and data collection forms will be applied again after 20 minutes
Control Group After the polyclinic controls of the patients on the day of the aCAG procedure data collection forms will be applied in the angiography unit 30 minutes before the procedure Routine care will be applied to patients in this group and music therapy will not be applied The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure and data collection forms will be applied again 20 minutes later
Ethical considerations Ethical approval will be obtained from the Bolu Abant İzzet Baysal University Clinical Research Ethics Committee in order to conduct the study Institutional permission will be obtained from Izzet Baysal Training and Research Hospital where the study will be conducted In addition before starting the application written consent will be obtained by the researcher explaining the purpose of the study to those who meet the inclusion criteria of the study
Data analysis In evaluating the data the significance level was taken as p 005 and the data will be analyzed using the SPSS 2500 program In the evaluation of the data besides descriptive statistical methods frequency percentage and average Independent Samples Unrelated samples t test will be used for intergroup comparisons of parameters showing normal distribution and related samples t test will be used for intragroup comparisons In the intergroup comparisons of non-normally distributed parameters Kruskall Wallis will be used to determine the significant difference of variables with more than three subcategories the Mann Whitney U will be used to determine the group that causes the difference and the Wilcoxon signed rank test for the same group data will be used for intragroup comparisons of non-normally distributed parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None