Therapy on Perioperative Anxiety and Pain in Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMaternal and Child Health Hospital of Hubei Province
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
eoperative Education + Intraoperative Music Therapy Arm
Other interventionThe 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.
Preoperative Education Alone Arm
Other interventionThe 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: reoperative Education + Intraoperative Music Therapy ArmExperimental treatment 1 intervention
Group B: Preoperative Education Alone ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively2
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.
Time frame
Baseline, up to 12 hours postoperatively, up to 24 hours postoperativelySecondary outcomes
1
shivering index
The Cold Shivering Index Scale (CSIS) is used to evaluate the severity of intraoperative shivering. Scores range from 0 to 4, with specific criteria: 0 = No shivering 1. = Faint shivering (visible muscle contraction without body movement) 2. = Mild shivering (mild, controlled body movement) 3. = Moderate shivering (obvious body tremors affecting the surgical field) 4. = Severe shivering (uncontrollable whole-body shaking interfering with surgery). Higher scores indicate worse outcomes, reflecting more severe shivering and decreased patient comfort during surgery.
Time frame
baseline (before any intervention is initiated), Immediately After Birth,Perioperative2
Record of postoperative complications
Such as wound infection, urinary retention, bleeding, heart failure or pulmonary embolism, etc.
Time frame
Complications during hospitalization(assessed up to 5 days)Sponsors and contacts
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Source ClinicalTrials.gov