The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- anxiety assessment 8 hours after surgery
研究概览
简要总结
Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status.
Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •The patients that had an orthopedic operation
- •The patients who took spinal anesthesia
- •able to understand, read and speak Turkish, so they may complete the informed consent and questionaires
- •Aged 18 or older
- •Have a Body Mass Index (BMI) <40
- •ASA (American Society of Anaesthesiologists) I-II-III statuses.
排除标准
- •Patients with vision and hearing problems and inability to complete questionnaires,
- •The patients not have psychiatric disease history and psychiatric drug use,
- •The patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure)
- •The patients not underwent emergency surgeries
结局指标
主要结局
anxiety assessment 8 hours after surgery
时间窗: State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
pain assessment in the operating room
时间窗: The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain
Postoperative pain at 1 hours
时间窗: The pain was assessed followed at 1 hours postoperative period with numerical pain scale
The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.
Postoperative pain at 8 hours
时间窗: The pain was assessed followed at 8 hours postoperative period with numerical pain scale
The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
时间窗: Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
时间窗: Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
时间窗: Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
时间窗: Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
anxiety assessment 30 minutes before surgery
时间窗: State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
次要结局
未报告次要终点