RecruitingNot ApplicableNCT06970431

Therapy on Perioperative Anxiety and Pain in Patients

Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients


Sponsor

Maternal and Child Health Hospital of Hubei Province

Enrollment

300 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a mind-body therapy approach (such as music therapy, relaxation techniques, or similar interventions) to reduce anxiety and pain in women undergoing cesarean section or other obstetric procedures. **You may be eligible if...** - You are a woman between 18 and 40 years old - You are having a singleton pregnancy (carrying one baby) - Your physical health is in the low-to-moderate risk category (ASA grade I or II) - You do not have a history of serious pregnancy complications **You may NOT be eligible if...** - You have a history of serious pregnancy complications (such as preeclampsia or gestational diabetes) - You have severe mental illness - You have a high-risk pregnancy or are carrying multiple babies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEReoperative 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.

OTHERPreoperative 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.


Locations(1)

Na Li , MD

Wuhan, Hubei, China

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NCT06970431


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