Actively Recruiting
Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients
Led by Maternal and Child Health Hospital of Hubei Province · Updated on 2025-05-14
300
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how combining preoperative education with intraoperative music therapy affects anxiety and pain in women undergoing elective cesarean section. This prospective randomized controlled trial focuses on patients receiving combined spinal-epidural anesthesia. The study also examines effects on shivering, postoperative recovery, and satisfaction with nursing care to better understand how these interventions might improve the surgical experience. Participants are divided into two groups: one receiving both standardized preoperative education and personalized music therapy during and shortly after surgery, and a control group receiving only standard preoperative education. Education is provided by nurses one day before surgery, covering procedures and recovery. Music therapy involves wearing headphones with music at controlled volume starting one hour before surgery, continuing through the operation and for 30 minutes postoperatively. Nurses ensure proper use and volume control of the music equipment. Participants will be assessed at multiple time points before and after surgery using standardized scales for anxiety, pain, and shivering. Additional data on postoperative complications, recovery milestones like walking and breastfeeding, hospital stay length, and satisfaction with care will be collected. The study includes safety monitoring and aims to provide thorough evaluation over the early postoperative period.
CONDITIONS
Brief Title
Therapy on Perioperative Anxiety and Pain in Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 40 years
- Singleton pregnancy
- Eligible for elective cesarean section
- ASA grade I or II
- Able to provide informed consent and complete follow-up
You will not qualify if you...
- History of severe pregnancy complications such as preeclampsia or gestational diabetes mellitus
- Severe mental illness
- Any complications or diseases affecting study outcomes
- Refusal to participate or incomplete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive standardized preoperative education one day before surgery, covering surgical procedures, precautions, anesthesia, and postoperative recovery.
1 visit (in-person)
Duration - Surgery day
Participants undergo elective cesarean section surgery. Participants in the experimental group receive music therapy through headphones starting one hour before surgery, continuing during surgery, and for 30 minutes postoperatively to reduce anxiety and discomfort.
1 visit (in-person)
Duration - 24 hours post-surgery
Participants are monitored for anxiety, pain, shivering, and postoperative complications for up to 24 hours after surgery. Recovery indicators and satisfaction surveys are also collected during this time.
1 to 3 visits within 24 hours postoperatively
Duration - Up to 5 days post-surgery
Participants are observed for postoperative complications and recovery indicators during hospitalization for up to 5 days after surgery.
Approximately 1 to 2 visits during hospitalization
Trial Site Locations
Total: 1 location
1
Na Li , MD
Wuhan, Hubei, China, 430070
Actively Recruiting
Research Team
N
Na Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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