Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorMaternal and Child Health Hospital of Hubei Province
About this trial
this randomized controlled trial selects patients undergoing gynecological laparoscopy under general anesthesia. By using noise reduction earphones during surgery, the patient's postoperative pain score and demand for opioids are observed, providing a basis and reference for the efficacy and safety of noise reduction earphones in gynecological endoscopic surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standard monitoring techniques
Other intervention（3）atients were given the same anesthesia regimen. Standard monitoring techniques include electrocardiogram, pulse oximeter, heart rate and blood pressure monitoring, continuous monitoring of bispecific index of electroencephalography, and the use of remifentanil (0.3 mg/kg) Rapid sequence induction was performed using sufentanil (0.3 μ g/kg), propofol (2.5mg/kg), and rocuronium bromide (0.6 mg/kg). Anesthesia was maintained using remifentanil (0.1-0.2 μ g/0kg/min), inhaled sevoflurane (1%), and intravenous propofol (1-4 mg/kg/h) to maintain BIS 40-60, with heart rate and blood pressure within 20% of baseline values.
noise cancelling headphones
Other interventionThe treatment group started wearing noise cancelling headphones until the end of the surgery in the general anesthesia induction group to isolate intraoperative environmental noise,patients were given the same anesthesia regimen. Standard monitoring techniques include electrocardiogram, pulse oximeter, heart rate and blood pressure monitoring, continuous monitoring of bispecific index of electroencephalography, and the use of remifentanil (0.3 mg/kg) Rapid sequence induction was performed using sufentanil (0.3 μ g/kg), propofol (2.5mg/kg), and rocuronium bromide (0.6 mg/kg). Anesthesia was maintained using remifentanil (0.1-0.2 μ g/0kg/min), inhaled sevoflurane (1%), and intravenous propofol (1-4 mg/kg/h) to maintain BIS 40-60, with heart rate and blood pressure within 20% of baseline values.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Conventional processing group,Sham comparator 1 intervention
Group B: wearing noise cancelling headphones groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
pain scores
the patient's resting and exercise induced pain scores,by the Visual Analog Scale (VAS) It typically involves a 10-centimeter horizontal or vertical line, with endpoints labeled "no pain" (0) and "worst pain imaginable" (10).
Time frame
6, 12, and 24 hours postoperatively2
maximum pain scores
maximum pain scores at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively.by the Visual Analog Scale (VAS) It typically involves a 10-centimeter horizontal or vertical line, with endpoints labeled "no pain" (0) and "worst pain imaginable" (10).
Time frame
at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively.Secondary outcomes
1
maximum resting pain score
by the Visual Analog Scale (VAS) It typically involves a 10-centimeter horizontal or vertical line, with endpoints labeled "no pain" (0) and "worst pain imaginable" (10).
Time frame
within 24 hours postoperatively2
total opioid consumption
Time frame
within 24 hours postoperatively3
the number of PCIA pump buttons
Time frame
within 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov