Therapy on Perioperative Anxiety and Pain in Patients

Maternal and Child Health Hospital of Hubei Province

Status: Enrolling

Conditions: Anxiety; Music Therapy; Health Education

Treatments: Other: Preoperative Education Alone Arm; Other: eoperative Education + Intraoperative Music Therapy Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06970431

MCHH_012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

reoperative Education + Intraoperative Music Therapy Arm

Experimental group

Description:

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.

Treatment:

Other: eoperative Education + Intraoperative Music Therapy Arm

Preoperative Education Alone Arm

Active Comparator group

Description:

The control group only received standardized preoperative education.

Treatment:

Other: Preoperative Education Alone Arm