The Effect of Music Played to Liver Transplant Donors During Surgery on Hemodynamic Parameters and Cortisol Levels: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Serum Cortisol Levels During the Intraoperative Period
研究概览
简要总结
This randomized controlled trial investigates the effects of music played during liver donor surgery on hemodynamic parameters and cortisol levels. Ninety participants were divided into three groups: music, silence (with headphones but no sound), and a control group with no intervention. The study aimed to evaluate whether music can reduce stress-related physiological responses during surgery.
详细描述
This study was designed to evaluate the effects of music played during surgery on liver transplant donors. The research included 90 adult participants who underwent live liver donation surgeries. Participants were randomly assigned to one of three groups: music group (headphones with music), silence group (headphones without sound), and a control group (no headphones). Music intervention lasted for 30 minutes during the operation.
The primary objective was to examine whether intraoperative music exposure could reduce physiological stress, measured via cortisol levels. Secondary outcomes included changes in hemodynamic parameters such as systolic and diastolic blood pressure, pulse rate, oxygen saturation, and respiratory rate. Measurements were taken before and after the surgery.
The study was conducted at İnönü University Liver Transplant Institute, with ethical approval granted by the Malatya Clinical Research Ethics Committee (Approval No: 2021/52). The findings suggest that music may be an effective supportive intervention for reducing surgical stress.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 65 years
- •Undergoing elective surgery as a liver donor
- •No physical or mental condition preventing listening to music
- •Willing to participate voluntarily and signing the informed consent form
排除标准
- •Development of hemodynamic instability during anesthesia induction
- •Participants for whom the study could not be continued due to technical reasons during surgery
- •Participants who did not comply with the study protocol or had incomplete records
结局指标
主要结局
Change in Serum Cortisol Levels During the Intraoperative Period
时间窗: Intraoperative (from pre-induction to the 30th minute of surgery)
Serum cortisol levels were measured at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. Blood samples were drawn from the radial artery, centrifuged, stored at -80°C, and later analyzed using the ELISA method. The difference between the two measurements was calculated to evaluate the physiological impact of the interventions.
次要结局
- Change in Systolic Blood Pressure During the Intraoperative Period(Intraoperative (from pre-induction to the 30th minute of surgery))
- Change in Diastolic Blood Pressure During the Intraoperative Period(Intraoperative (from pre-induction to the 30th minute of surgery))
- Change in Heart Rate During the Intraoperative Period(Intraoperative (from pre-induction to the 30th minute of surgery),)
- Change in Respiratory Rate During the Intraoperative Period(Intraoperative (from pre-induction to the 30th minute of surgery))
- Change in Peripheral Oxygen Saturation (SpO₂) During the Intraoperative Period(Intraoperative (from pre-induction to the 30th minute of surgery))
研究者
Hasan SARITAŞ
Assistant Professor
Siirt University