NCT06970431

Therapy on Perioperative Anxiety and Pain in Patients

Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Maternal and Child Health Hospital of Hubei Province · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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). 1. Preoperative Health Education Conducted by dedicated nurses 1 day before surgery, covering surgical procedures, precautions, anesthesia, and postoperative recovery. 2. 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: Anxiety: GAD-7 scale (preoperative, 6h, 12h, 24h postoperatively). Pain: VAS scale (preoperative, 6h, 12h, 24h postoperatively). Shivering index: Cold Shivering Index Scale (preoperative, before headphone use, at discharge from the operating room). Postoperative complications: Wound infection, urinary retention, hemorrhage, heart failure, or pulmonary embolism. Recovery indicators: Ambulation time, anal exhaust time, lactation time, hospital stay. Satisfaction surveys: Nursing and anesthesia satisfaction via questionnaires 24h postoperatively. 4. Study Population Inclusion criteria: 18-40 years old, singleton pregnancy, eligible for elective cesarean section. No severe pregnancy complications (e.g., preeclampsia, gestational diabetes). Able to provide informed consent and complete follow-ups. Exclusion criteria: Complications or diseases affecting study outcomes. Severe mental illness preventing protocol understanding. Refusal to participate or incomplete follow-ups. Allergy to music/headphones. II. Technical Route Literature review \& protocol design: Develop the study plan and obtain ethical approval. Patient recruitment \& randomization: Enroll patients per criteria; use random number tables for grouping. Intervention \& data recording: Standardized interventions by the research team; regular data verification. Data analysis \& reporting: Statistical analysis to compare group differences; summarize findings and draft reports. III. Feasibility Analysis Sample size: Estimated 64 patients per group (140 total, including 10% dropout rate) based on anxiety score differences and literature. Ethical feasibility: Informed consent obtained; complies with ethical review requirements. Technical feasibility: Hospital equipped with nursing tools (headphones, assessment scales) and a skilled team. Resource feasibility: Reasonable budget and 10-month timeline ensure timely data collection, analysis, and reporting.

Conditions

• Music Therapy
• Anxiety
• Health Education

Interventions

Type	Name	Description
OTHER	eoperative Education + Intraoperative Music Therapy Arm	The experimental group implemented standardized preoperative education one day before the operation (covering knowledge such as the surgical procedure), headphone fitting one hour before the operation (with a volume of 45-55 decibels), and music therapy throughout the operation and for 30 minutes after the operation (parturients can choose personalized music). Full-time nurses were responsible for the preoperative education, and trained operating room nurses implemented the music therapy. Meanwhile, data such as anxiety scores, pain scores, shivering index, postoperative complications, postoperative recovery status, and satisfaction surveys were collected at multiple time points through standardized tools.
OTHER	Preoperative Education Alone Arm	The control group received the same standardized preoperative education by full-time nurses one day before the operation, covering surgical procedures, precautions, anesthesia, and postoperative recovery. Data were collected at multiple time points using standardized tools, including anxiety scores (before and 6, 12, 24 h after surgery via GAD-7), pain scores (before and 6, 12, 24 h after via VAS), shivering index (before surgery, before wearing headphones, when leaving OR), postoperative complications (wound infection, urinary retention, etc.), postoperative recovery indicators (time to get out of bed, anal exhaust, breastfeeding start, hospital stay), and satisfaction surveys (24 h after surgery). Importantly, the control group had no music therapy intervention before, during, or after surgery.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-06-01
• Completion: 2026-01-10
• First posted: 2025-05-14
• Last updated: 2025-05-14

Locations

1 site across 1 country: China