Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- anxiety score
研究概览
简要总结
This study aims to explore the effects of preoperative education combined with intraoperative music therapy on perioperative anxiety and pain in patients undergoing elective cesarean section. The study subjects were patients scheduled for cesarean section under combined spinal - epidural anesthesia. A prospective study design with random grouping was adopted. Through systematic preoperative education and intraoperative music intervention, multi - dimensional evaluations were carried out to analyze the effects of preoperative education combined with intraoperative music therapy on the relief of perioperative anxiety, pain and shivering in patients, as well as its impact on postoperative recovery and nursing satisfaction.
详细描述
I. Research Methods A prospective randomized controlled trial design will be used. Eligible elective cesarean patients will be randomly assigned to an experimental group (preoperative education + intraoperative music therapy) or a control group (routine preoperative education only).
- Preoperative Health Education Conducted by dedicated nurses 1 day before surgery, covering surgical procedures, precautions, anesthesia, and postoperative recovery.
- Intraoperative Music Therapy Experimental group: Headphones fitted 1 hour preoperatively at 45-55 decibels, playing personalized or pre-screened music continuously during surgery and for 30 minutes postoperatively.
Intervention timing: Headphone adaptation and volume adjustment 1 hour preoperatively; continuous playback during surgery; 30-minute playback postoperatively to reduce anxiety and discomfort.
Executors: Preoperative education by specialized nurses; music therapy by trained operating room nurses to ensure equipment and volume stability. 3. Data Collection
Assessments at specified time points using standardized tools:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA grade I or II, aged 18-40 years female must be singleton pregnancy eligible
排除标准
- •History of pregnancy-related complications severe pregnancy complications (e.g., preeclampsia, gestational diabetes mellitus) Severe mental illness
研究组 & 干预措施
reoperative Education + Intraoperative Music Therapy Arm
The standardized preoperative education and the individualized music therapy during the operation are implemented jointly, and the patients' perioperative anxiety values, pain scores, shivering index, etc. are collected.
干预措施: eoperative Education + Intraoperative Music Therapy Arm (Other)
Preoperative Education Alone Arm
The control group only received standardized preoperative education.
干预措施: Preoperative Education Alone Arm (Other)
结局指标
主要结局
anxiety score
时间窗: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
Before the operation and at 6 hours, 12 hours, and 24 hours after the operation, the Generalized Anxiety Disorder 7-item scale (GAD-7 scale) is used.The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a widely used tool to assess the severity of generalized anxiety symptoms. Score Range: Scores range from 0 to 21, with each of the 7 items rated on a 4-point scale (0 = "Not at all" to 3 = "Nearly every day"). Interpretation: Higher scores indicate worse outcomes, reflecting more severe anxiety symptoms. Specifically: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety This scale helps clinicians and researchers quantify anxiety levels, with higher scores signifying greater distress and functional impairment.
pain score
时间窗: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
The Visual Analogue Scale (VAS) is used to assess pain intensity. Full Name: Visual Analogue Scale Score Range: Scores range from 0 to 10, where 0 = "No pain" and 10 = "Worst pain imaginable". Interpretation: Higher scores indicate worse outcomes, reflecting more severe pain. Assessment Time Points: Pain is evaluated at preoperative baseline, and at 6 hours, 12 hours, and 24 hours postoperatively to measure acute pain changes during the perioperative period. This validated single-item scale allows patients to rate their pain on a continuous numeric scale, providing a straightforward method to quantify pain severity. Clear time-specific assessments (preoperative and postoperative time points) ensure standardized data collection for comparing intervention effects between groups.
次要结局
- shivering index(baseline (before any intervention is initiated), Immediately After Birth,Perioperative)
- Record of postoperative complications(Complications during hospitalization(assessed up to 5 days))
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province