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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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| reoperative Education + Intraoperative Music Therapy Arm | Experimental | 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. |
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| Preoperative Education Alone Arm | Active Comparator | The control group only received standardized preoperative education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eoperative Education + Intraoperative Music Therapy Arm | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| anxiety score | 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. | Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively |
| pain score | 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. | Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| shivering index | The Cold Shivering Index Scale (CSIS) is used to evaluate the severity of intraoperative shivering. Scores range from 0 to 4, with specific criteria: 0 = No shivering
Higher scores indicate worse outcomes, reflecting more severe shivering and decreased patient comfort during surgery. |
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Inclusion Criteria： ASA grade I or II, aged 18-40 years female must be singleton pregnancy eligible
Exclusion Criteria:
History of pregnancy-related complications severe pregnancy complications (e.g., preeclampsia, gestational diabetes mellitus) Severe mental illness
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na Li, MD | Contact | +862763490107 | lina@hbfy.com |
| Name | Affiliation | Role |
|---|---|---|
| Na Li, MD | Maternal and Child Health Hospital of Hubei Province | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Na Li , MD | Recruiting | Wuhan | Hubei | 430070 | China |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
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| Preoperative Education Alone Arm | Other | 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. |
|
| baseline (before any intervention is initiated), Immediately After Birth,Perioperative |
| Record of postoperative complications | Such as wound infection, urinary retention, bleeding, heart failure or pulmonary embolism, etc. | Complications during hospitalization(assessed up to 5 days) |
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |