Effectiveness of Music During Cardiac Catheterization

Study Overview
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Brief Summary
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The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research. Before angiography, Child Fear Scale, State-Trait Anxiety Scale (STAI-TX), and Vital Signs Follow-up Form will be applied to all children taking part in the study and life signs will be recorded. During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute. Numerical Pain Scale, Child Fear Scale, State Anxiety Scale, and Vital Signs Follow-up Form will be re-evaluated to all three groups after angiography.

Detailed Description
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This study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18. The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research. Before angiography, Child Fear Scale, State-Trait Anxiety Scale (STAI-TX), and Vital Signs Follow-up Form will be applied to all children taking part in the study and life signs will be recorded. The sample size of the study was determined and the effect size was 0.25 based on the Standard effect sizes determined by Cohen. In the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group. During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute. Numerical Pain Scale, Child Fear Scale, State Anxiety Scale, and Vital Signs Follow-up Form will be re-evaluated to all three groups after angiography.

Official Title
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Effectiveness of Music During Cardiac Catheterization On Children's Pain, Fear, Anxiety and Vital Signs: A Randomized, Double-Blind Controlled Trial

Conditions
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Angiography

Intervention / Treatment
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* Other: music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteering to participate in research Being between 7-18 years of age Lack of communication problems (vision, hearing, mental) Being informed about surgical intervention Lack of prior surgical intervention experience Receiving sedoanalgesia during angiography Exclusion Criteria: Intubation of the child during angiography Parent's refusal to take part in the study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>No music will be played to the control group. | |
| Active Comparator: Intervention 1<br>During angiography, the Intervention-1 group will listen to the music that the child wants to listen. | Other: music<br>* During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the Arts of Fugue by Bach. No music will be played to the control group.<br>|
| Active Comparator: Intervention-2<br>The Intervention-2 group will listen to the music which determined by the researchers. The music which determined by the researchers is The art of fugue by Johann Sebastian Bach. The music to be played has been decided by examining the literature. (DOI: 10.4274/jpr.24892) | Other: music<br>* During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the Arts of Fugue by Bach. No music will be played to the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child's heart rate | the child's pulse rate will be measured. | baseline (at the beginning of angiography) | 
| child's heart rate | the child's pulse rate will be measured. | 1st minute of the angiography | 
| child's heart rate | the child's pulse rate will be measured. | 5th minute of the angiography | 
| child's heart rate | the child's pulse rate will be measured. | 10th minute of the angiography | 
| child's heart rate | the child's pulse rate will be measured. | 30th minute of the angiography | 
| child's heart rate | the child's pulse rate will be measured. | 60th minute of the angiography | 
| child's respiratory rate | the child's respiratory rate will be measured. | Baseline (at the beginning of angiography) | 
| child's respiratory rate | the child's respiratory rate will be measured. | 1st minute of the angiography | 
| child's respiratory rate | the child's respiratory rate will be measured. | 5th minute of the angiography | 
| child's respiratory rate | the child's respiratory rate will be measured. | 10th minute of the angiography | 
| child's respiratory rate | the child's respiratory rate will be measured. | 15th minute of the angiography | 
| child's respiratory rate | the child's respiratory rate will be measured. | 30th minute of the angiography | 
| child's respiratory rate | the child's respiratory rate will be measured. | 60th minute of the angiography | 
| child's blood pressure | the child's blood pressure will be measured. | baseline (at the beginning of angiography) | 
| child's blood pressure | the child's blood pressure will be measured. | 1st minute of the angiography | 
| child's blood pressure | the child's blood pressure will be measured. | 5th minute of the angiography | 
| child's blood pressure | the child's blood pressure will be measured. | 10th minute of the angiography | 
| child's blood pressure | the child's blood pressure will be measured. | 15th minute of the angiography | 
| child's blood pressure | the child's blood pressure will be measured. | 30th minute of the angiography | 
| child's blood pressure | the child's blood pressure will be measured. | 60th minute of the angiography | 
| child's body temperature | the child's body temperature will be measured. | Baseline (at the beginning of angiography) | 
| child's body temperature | the child's body temperature will be measured. | 1st minute of the angiography | 
| child's body temperature | the child's body temperature will be measured. | 5th minute of the angiography | 
| child's body temperature | the child's body temperature will be measured. | 10th minute of the angiography | 
| child's body temperature | the child's body temperature will be measured. | 15th minute of the angiography | 
| child's body temperature | the child's body temperature will be measured. | 30th minute of the angiography | 
| child's body temperature | the child's body temperature will be measured. | 60th minute of the angiography | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | baseline (at the beginning of angiography) | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | 1st minute of the angiography | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | 5th minute of the angiography | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | 10th minute of the angiography | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | 15th minute of the angiography | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | 30th minute of the angiography | 
| child's oxygen saturation | the child's oxygen saturation will be measured. | 60th minute of the angiography | 
| child's fear | Child fear will be assessed by Children's Fear Scale. This scale includes 5 different facial expressions. This scale is rated from 0-4 and it is stated that it is a reliable and valid measurement tool for the assessment of fear. | up to 60 min (when the child wakes up from anaesthetic) | 
| child's anxiety | Child anxiety will be assessed by the State Anxiety Scale. This scale includes 5 different facial expressions. The children are expected to evaluate how they feel at the moment. Expressions such as I feel very angry, I feel angry or I do not feel angry are asked to mark the most appropriate one for them. The total number of items is 20. The lowest score is 20, the highest the score is 60. | up to 60 min (when the child wakes up from anaesthetic) | 
| child's pain | Child pain will be assessed by the  Numeric Pain Scale. This method is intended to determine the severity of pain and to explain the patient's pain in numbers. On numerical scales, it starts with the absence of pain (0) and reaches the level of unbearable pain (10). | up to 60 min (when the child wakes up from anaesthetic) |