Therapy on Perioperative Anxiety and Pain in Patients

NCT06970431 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Music Therapy
  • Anxiety
  • Health Education

Interventions

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.

Sponsors & Collaborators

  • Maternal and Child Health Hospital of Hubei Province

    lead OTHER

Principal Investigators

  • Na Li, MD · Maternal and Child Health Hospital of Hubei Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-06-01
Completion
2026-01-10

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970431 on ClinicalTrials.gov