Therapy on Perioperative Anxiety and Pain in Patients

NCT06970431 | Recruiting DMC

• 1 other identifier: MCHH_012
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Music Therapy; Anxiety; Health Education

Outcome Measures

Primary Outcomes (2)

• anxiety score

  Before the operation and at 6 hours, 12 hours, and 24 hours after the operation, the Generalized Anxiety Disorder 7-item scale (GAD-7 scale) is used.The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a widely used tool to assess the severity of generalized anxiety symptoms. Score Range: Scores range from 0 to 21, with each of the 7 items rated on a 4-point scale (0 = "Not at all" to 3 = "Nearly every day"). Interpretation: Higher scores indicate worse outcomes, reflecting more severe anxiety symptoms. Specifically: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety This scale helps clinicians and researchers quantify anxiety levels, with higher scores signifying greater distress and functional impairment.

  Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively

• pain score

  The Visual Analogue Scale (VAS) is used to assess pain intensity. Full Name: Visual Analogue Scale Score Range: Scores range from 0 to 10, where 0 = "No pain" and 10 = "Worst pain imaginable". Interpretation: Higher scores indicate worse outcomes, reflecting more severe pain. Assessment Time Points: Pain is evaluated at preoperative baseline, and at 6 hours, 12 hours, and 24 hours postoperatively to measure acute pain changes during the perioperative period. This validated single-item scale allows patients to rate their pain on a continuous numeric scale, providing a straightforward method to quantify pain severity. Clear time-specific assessments (preoperative and postoperative time points) ensure standardized data collection for comparing intervention effects between groups.

  Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively

Secondary Outcomes (2)

• shivering index

  baseline (before any intervention is initiated), Immediately After Birth,Perioperative

• Record of postoperative complications

  Complications during hospitalization(assessed up to 5 days)

Study Arms (2)

reoperative Education + Intraoperative Music Therapy Arm

EXPERIMENTAL

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.

Other: eoperative Education + Intraoperative Music Therapy Arm

Preoperative Education Alone Arm

ACTIVE COMPARATOR

The control group only received standardized preoperative education.

Other: Preoperative Education Alone Arm

Interventions

eoperative Education + Intraoperative Music Therapy Arm OTHER

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.

reoperative Education + Intraoperative Music Therapy Arm

Preoperative Education Alone Arm OTHER

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.

Preoperative Education Alone Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• History of pregnancy-related complications severe pregnancy complications (e.g., preeclampsia, gestational diabetes mellitus) Severe mental illness

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Na Li , MD

Wuhan, Hubei, 430070, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Health Education

Condition Hierarchy (Ancestors)

Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Na Li, MD

  Maternal and Child Health Hospital of Hubei Province

  STUDY DIRECTOR

Central Study Contacts

Na Li, MD

CONTACT

+862763490107; lina@hbfy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 14, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: January 10, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)