Effect of Music Therapy on Pain, Anxiety and Vital Signs Before and During Coronary Angiography

Abant Izzet Baysal University1 个研究点分布在 1 个国家目标入组 102 人开始时间: 2021年1月27日最近更新: 2021年9月30日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Abant Izzet Baysal University
入组人数: 102
试验地点: 1
主要终点: Means of subjective anxiety scores

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 study.The 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 = 34).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 (VAS).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.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 angiography hall during the CAG procedure. Routine care will be applied to patients in this group and music therapy will not be applied.

详细描述

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 angiography(CAG) 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 = 0.05 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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age or older
•Can speak and understand Turkish
•No hearing problems
•Oriented to place and time
•Have no psychiatric illness
•Sedative or analgesic medication within the last 24 hours
•where the intervention will be made in the ral zone
•The first time angiography procedure will be applied
•Individuals who are volunteers will be included in the study.

排除标准

•Under the age of 18
•Do not speak Turkish
•Have a hearing problem
•Without a place and time orientation
•Have any psychiatric illness
•Using sedative or analgesic drugs in the last 24 hours
•To be intervened outside the femoral area
•Previous angiography procedure
•Non-volunteer individuals will not be included in the study.

研究组 & 干预措施

music therapy before the angiography

Experimental

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. 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 individual's choice. Instrumental works will be uploaded to the portable MP3 player provided by the researchers.

干预措施: music therapy (Other)

music therapy during the angiography

Experimental

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. 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 individual's choice.

干预措施: music therapy (Other)

control group

No Intervention

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. 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.

结局指标

主要结局

Means of subjective anxiety scores

时间窗: up to 20 minutes post-angiography

State-Trait Anxiety Scale is used to measure subjective anxiety. 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 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 20-item trait anxiety inventory shows the general feelings of the person under 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.

Means of diastolic blood pressure (mmHg)