Clinical trial NCT06970431: Therapy on Perioperative Anxiety and Pain in Patients
Official title: Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Music Therapy
Anxiety
Health Education
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: anxiety score
timeFrame: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
measure: pain score
timeFrame: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
Secondary outcomes:
measure: shivering index
timeFrame: baseline (before any intervention is initiated), Immediately After Birth,Perioperative
measure: Record of postoperative complications
timeFrame: Complications during hospitalization(assessed up to 5 days)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Na Li , MD
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: STUDY_DIRECTOR
References: