The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 512
- 试验地点
- 4
- 主要终点
- State-Trait Anxiety Inventory
研究概览
简要总结
Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. The objective of this randomized controlled trial was to examine the impact of music and breathing exercises on anxiety and pain levels in individuals undergoing coronary angiography. The study, conducted as a single-blind, randomized controlled trial, involved a sample of 165 patients, with 55 in each group: the control group, the breathing exercise group, and the music therapy group. Patients in the music group listened to music during angiography, those in the breathing exercise group practiced exercises 30 minutes before the procedure, while the control group received standard treatment. Anxiety levels were assessed both before and after the procedure, and pain levels were measured post-procedure. The study strictly adhered to the CONSORT statement guidelines.
详细描述
Breathing exercises and music therapy have been demonstrated to be used in managing anxiety and pain in many clinical conditions, only a few studies have investigated their effectiveness on anxiety and pain during coronary angiography. Pain and anxiety are commonly experienced symptoms during coronary angiography. Therefore, the objective of this study is to examine the effects of the music and breathing exercises on anxiety and pain in patients undergoing coronary angiography.
Design This single-center, single-blind, randomized controlled trial was conducted in Izmir, Turkey, from July 2021 to July 2022. Participants were randomly assigned to one of three groups: intervention 1 (music), intervention 2 (breathing exercises), or control (standard care), in a 1:1:1 ratio. The study received approval from the Ethics Review Committee of a university hospital, and written informed consent was obtained from each participant.
Sample The participants were selected by the researcher from patients who were scheduled to undergo coronary angiography at the Cardiology clinic of a university hospital. Patients were included in the study if they met the following criteria: being scheduled for their first coronary angiography, being above 18 years of age, not being dependent on drugs or alcohol, having orientation to time and place, not experiencing respiratory distress, not having a history of serious psychological problems in the past 6 months, not taking any medication that suppresses anxiety symptoms and pain, and consenting to participate in the study. Patients who did not like music due to cultural reasons, stents implanted during angioplasty, required urgent treatment for the management of cardiac arrhythmias, had hearing problems, or had difficulty performing breathing exercises were excluded.
The sample size was calculated based on previous research on the effects of coronary angiography on pain and anxiety as well as our pilot study. We aimed to have a sufficient sample size to detect a difference of 2 units (mean ± SD) in pain levels between the intervention and control groups. 165 subjects were targeted for this study.
2.3. Randomization Eligible participants were randomly assigned to either the intervention groups or control group in a 1:1 ratio using a permuted block randomization method with a block size of 6. A random allocation sequence was generated by an off-site statistician who was not involved in participant recruitment. Allocation concealment was ensured by employing sealed opaque envelopes containing sequence numbers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The nurse responsible for conducting all measurements, including pain and anxiety assessments using the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI), was not part of the research team.
The nurse, being independent and not aware of the participants' group assignments, helps to ensure that the assessments are conducted impartially, without knowledge of which intervention each participant received.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being scheduled for their first coronary angiography
- •being above 18 years of age
- •not being dependent on drugs or alcohol
- •having orientation to time and place
- •not experiencing respiratory distress
- •not having a history of serious psychological problems in the past 6 months
- •not taking any medication that suppresses anxiety symptoms and pain
排除标准
- •Patients who did not like music due to cultural reasons
- •stents implanted during angioplasty
- •required urgent treatment for the management of cardiac arrhythmias
- •had hearing problems,
- •had difficulty performing breathing exercises
研究组 & 干预措施
Music therapy
After the patient was taken to the angiography laboratory, music was played using a digital MP3 player approximately 10 minutes before the angiography procedure began.
干预措施: Music therapy (Behavioral)
Control Group
All data collection steps were applied identically to the control group patients, except for music application and deep breathing exercises. All patients in the study group received the same routine care.
Breathing exercise
Individuals in the breathing exercise group were made to do breathing exercises by the researcher in the patient room 30 minutes before coronary angiography
干预措施: Breathing exercise (Behavioral)
结局指标
主要结局
State-Trait Anxiety Inventory
时间窗: an average of 6 months
State-Trait Anxiety Inventory (STAI), originally developed by Spielberg et al. to assess state and trait anxiety levels separately, has been adapted into the Turkish language by Öner and Le Compte. Validation and reliability studies for the Turkish version have been conducted, confirming its robustness. The scale consists of 40 items, with 20 items measuring state anxiety and 20 items measuring trait anxiety. Respondents were instructed to choose the response that best fits each item on the scale: "almost never," "sometimes," "often," or "almost always." Higher scores on the scale indicate greater levels of anxiety
Visual Analog Scale
时间窗: an average of 6 months
It is a scale used to assess pain intensity. Visual Analog Scale (VAS) is stated to be more sensitive and reliable in measuring pain intensity compared to other single-dimensional scales. The VAS is a 10 cm ruler that can be used horizontally and vertically, with "0" representing no pain at one end and "10" representing the most severe pain at the other end. The patient marks the level of pain intensity they are experiencing on this ruler. Pain severity scores were measured in millimetres.
次要结局
未报告次要终点
研究者
Ulku Gunes
Profesor
Ege University