Effect of Sufi Music on Sleep, Cardiac Symptoms and Vital Signs in Open-Heart Surgery Patients
The Effect of Sufi Music Delivered Via a Bone-Conduction Pillow Speaker on Sleep Quality, Cardiac Symptoms and Vital Signs in Open-Heart Surgery Patients: A Randomised Controlled Trial
The aim of this randomised, double-blind, controlled experimental study is to investigate the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in open-heart surgery patients. The study will be conducted with three groups, each comprising 30 patients (90 in total): an intervention group, a sham group and a routine care control group. Participants in the intervention group will listen to relaxing Sufi music without percussion for 15-20 minutes, starting at 21:30, through a bone-conduction pillow speaker placed under the pillow. Participants in the sham group will have an identical-looking pillow speaker placed under their pillow for the same duration, but no sound will be transmitted. Participants in the control group will receive only the hospital's standard night-care protocol, with no device or music intervention. Vital signs (blood pressure, pulse, respiratory rate and oxygen saturation) will be measured immediately before and after the application period in all groups, and sleep quality will be assessed the following morning between 08:00 and 09:00 using the Richards-Campbell Sleep Questionnaire. Cardiac symptoms will be assessed in all groups with a Cardiac Symptom Survey before discharge.
研究概览
详细说明
Cardiovascular diseases are among the leading causes of morbidity and mortality, affecting millions of people worldwide each year. Pharmacological, interventional and surgical methods are used in their treatment. Open-heart surgery is performed as a life-saving procedure in the treatment of coronary artery disease and valvular heart disease. It is estimated that approximately 1-1.5 million cardiac surgical procedures are performed worldwide every year. In Türkiye, too, cardiac surgery is an important area of healthcare delivery; it has been reported that more than 70,000 heart operations were performed in the 2022-2023 period, a considerable proportion of which were coronary artery bypass graft (CABG) surgeries.
After CABG surgery, patients face multidimensional problems such as pain, anxiety, sleep disturbance and haemodynamic fluctuations. In particular, during the intensive care and early ward period, noise, immobility, mechanical ventilation, pain and environmental stressors disrupt sleep continuity, which adversely affects recovery, rehabilitation and overall prognosis. Impaired sleep quality may weaken immune function and delay wound healing, thereby negatively affecting the postoperative recovery process. Sleep, which is an important component of physical and psychological well-being, has been reported to be impaired in 48-90% of patients after cardiac surgery, and this disturbance may persist in the days following surgery.
Cardiac symptoms such as chest pain, dyspnoea, fatigue, leg swelling and palpitations are very common in both the early and late recovery periods after CABG. Chronic chest pain and arrhythmias restrict patients' activities of daily living and adversely affect the recovery process and quality of life. One study reported that postoperative arrhythmia developed in 54% of patients who underwent open-heart surgery, with sinus tachycardia being the most common arrhythmia (66.7%). Dyspnoea, in turn, is associated with pulmonary complications that may develop after cardiopulmonary bypass and may increase morbidity. Fatigue and weakness, which are commonly observed in the postoperative period, may also negatively affect patients' recovery. Therefore, maintaining cardiac function, ensuring adequate tissue perfusion and preserving vital signs are among the fundamental components of postoperative care after open-heart surgery.
Studies have shown that non-pharmacological approaches significantly improve sleep quality after cardiac surgery and also reduce pain and anxiety. Music-based interventions stand out as a low-cost, feasible complementary approach with a low risk of serious adverse effects in cardiac surgery patients. One study reported that a music intervention was an effective complementary intervention for prolonging sleep duration and improving sleep quality in the early postoperative period in patients undergoing mechanical mitral valve replacement. In addition, there are studies indicating that music interventions may have favourable effects on certain physiological indicators, such as heart rate, blood pressure and oxygen saturation, following cardiac and cardiothoracic surgery. In patients undergoing open-heart surgery, music interventions have been reported to reduce anxiety, shorten the length of intensive care and hospital stay, and improve some vital signs.
Bone-conduction sound technology allows auditory stimuli to be delivered through a different transmission mechanism; integrating this technology into contact surfaces such as pillows offers an alternative approach for presenting auditory stimuli before sleep. Although the beneficial effects of music interventions on pain, anxiety and certain physiological parameters after cardiac surgery are supported, research that simultaneously examines the effects of Sufi music and the use of a bone-conduction pillow speaker on cardiac symptoms and sleep quality in patients undergoing open-heart surgery is very limited. Therefore, this study aims to examine the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in patients undergoing open-heart surgery.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yeliz CİĞERCi
- 电话号码：0555 217 29 48
- 邮箱：yeliz.ceylin@hotmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 years or older,
- Literate in Turkish (able to read and write),
- Having undergone elective open-heart surgery (coronary artery bypass graft surgery) and extubated after the operation,
- Fully oriented to place, time and person and fully cooperative,
- Able to complete the cognitive function assessment scales,
- Planned to receive inpatient treatment in the clinical setting for at least two days and receiving inpatient treatment in the ward at the time of the study (21:30),
- Without severe hearing loss that would impair bone-conduction sound transmission or the perception of verbal instructions,
- Patients who voluntarily agree to participate and sign the Informed Voluntary Consent Form will be included in the study.
Exclusion Criteria:
- Undergoing emergency surgery, Having a severe neurological deficit (e.g., cerebrovascular event) or a diagnosed psychiatric disorder, Requiring mechanical ventilator support for longer than 24 hours in the postoperative period, Having persistent haemodynamic instability, requiring an intra-aortic balloon pump, or receiving high-dose inotropic support, Having a history of diagnosed sleep apnoea or chronic insomnia, Having received sedative, hypnotic, anxiolytic or strong analgesic (e.g., opioid) medication within 4-6 hours before the intervention time, Having severe pain (VAS >4) requiring analgesic treatment before the intervention, Having an open wound, lesion, burn or acute surgical incision in the temporal/mastoid region or the cranial bones where the bone-conduction pillow speaker will make contact, and patients using a cochlear implant whose device cannot be removed in the evening hours.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental Group: Sufi Music Group
A bone-conduction pillow speaker will be placed under the patients' pillows. Starting at 21:30, patients will listen to relaxing Sufi music without percussion for 15-20 minutes. The music will be delivered via the bone-conduction pillow speaker to isolate the patient from external noise. |
Pre-intervention: At 21:30, patients' vital signs, consisting of blood pressure, pulse, respiratory rate and oxygen saturation, will be measured and recorded before the intervention. Intervention: A bone-conduction pillow speaker will be placed under the patients' pillows. Starting at 21:30, patients will listen to relaxing Sufi music without percussion for 15-20 minutes. The music will be delivered via the bone-conduction pillow speaker to isolate the patient from external noise. Post-intervention: Immediately after the intervention ends, patients' vital signs will be measured and recorded again. |
|
安慰剂比较：Sham (Placebo) Group
A bone-conduction pillow speaker identical in appearance to the one used in the intervention group will be placed under the patients' pillows; however, no sound or music will be transmitted to the device (passive device application). Patients will remain in contact with the pillow for the same duration (15-20 minutes). Patients will be informed that a module transmitting sound at a special low/subliminal frequency that cannot be directly heard by the human ear is being applied. |
Pre-intervention: At 21:30, pre-intervention vital signs will be measured and recorded in exactly the same manner as in the intervention group. Intervention: A bone-conduction pillow speaker identical in appearance to the one used in the intervention group will be placed under the patients' pillows; however, no sound or music will be transmitted to the device (passive device application). Patients will remain in contact with the pillow for the same duration (15-20 minutes). Patients will be informed that a module transmitting sound at a special low/subliminal frequency that cannot be directly heard by the human ear is being applied. Post-intervention: Immediately after the designated period has elapsed, patients' post-intervention vital signs will be measured and recorded again. Following morning: On the following morning, within the designated time interval, the Richards-Campbell Sleep Questionnaire will be administered. |
|
无干预：Control group
No device or music intervention will be applied to the patients; only the hospital's standard night-care protocol will be continued. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Richards-Campbell Sleep Questionnaire
大体时间：Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
|
This questionnaire was developed by Richards (1987) to assess the sleep quality of patients in intensive care and clinical settings [28], and its Turkish validity and reliability study was conducted by Özlü and Özer (2015) [29]. The questionnaire consists of six items and is scored on a scale of 0 to 100. However, the sixth item, which measures external stimuli/environmental factors (noise level), is not included in the calculation of the total score. The overall sleep quality score is calculated by dividing the sum of the scores obtained from the first five items by the number of items. The minimum score that can be obtained from the questionnaire is 0 and the maximum is 100. Higher scores indicate better sleep quality. In the evaluation, a score range of "0-25" represents very poor sleep quality, whereas a range of "76-100" represents very good sleep quality. The internal consistency |
Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiac Symptom Survey
大体时间：Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
|
The scale developed by Nieveen et al. (2008) [32] was adapted into Turkish, with validity and reliability analyses conducted by Özkan and Taştan (2016) [33]. The scale covers a total of 10 core cardiac symptoms: chest pain, shortness of breath, fatigue, feeling sad, sleep problems, pain at the surgical site, leg swelling, palpitations, anxiety and loss of appetite. The scale is structurally composed of three main dimensions, namely "symptom perception", "symptom appraisal" and "response to symptoms", and assessments are made on a Likert-type scale scored from 0 to 10. A score of "0" indicates that the symptom is absent or does not affect the patient, whereas "10" represents the highest negative impact of the symptom on the patient. In the appraisal dimension, the mean of the frequency and severity of each symptom is calculated, whereas in the response dimension, the degree to which symptoms limit phy |
Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.