Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain

Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain During Gynecological Laparoscopic Surgery ：a Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Noise Cancelling Headphones
• Intervention / Treatment: Other: Standard monitoring techniques; Other: noise cancelling headphones

Detailed Description

Every year, 200 million surgical procedures are performed worldwide, and 40-65% of patients experience moderate to severe pain after surgery Failure to provide sufficient postoperative analgesia increases the risk of surgical complications and affects patients' early activity and recovery . Opioids are still the main method of treatment, and their side effects include urinary retention, itching, nausea, vomiting, postoperative intestinal obstruction, dizziness and cognitive impairment . Researchers pay more and more attention to non pharmacology and non-invasive analgesia methods, including music therapy, traditional Chinese medicine acupuncture and moxibustion and watching educational videos . Due to the introduction of various surgical tools, the noise pollution in the operating room has gradually intensified, affecting surgical patients and medical staff. Previous studies have shown that general anesthesia does not hinder the brain's processing ability for sound and language; The patient's auditory cortex remains active , and even in anesthesia induced coma, the patient can still maintain the ability to understand auditory information. Other recent studies have found that intraoperative exposure to positive auditory stimuli, including music, treatment suggestions and white noise, can reduce postoperative pain, environmental protection, and acupuncture and moxibustion can also have a similar positive impact . Therefore, 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Na Li, MD; Phone Number: +862763490107; Email: lina@hbfy.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Maternal and Child Health Hospital of Hubei Province,
      • Contact: Na Li, MD; Phone Number: +862763490107; Email: lina@hbfy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

ASA grade I or II, aged 18-55 years , female were selected for gynecological laparoscopy under elective general anesthesia. -

Exclusion Criteria:

History of serious illness requiring further care in the intensive care unit after surgery; Abnormal hearing; Postoperative mechanical ventilation or continued anesthesia or sedation is required; Preoperative chronic pain or long-term use of painkillers; other factors that hinder patients from cooperating with the research plan

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Conventional processing group,; Standard monitoring techniques ,Conventional processing without noise cancelling headphones	Other: Standard monitoring techniques; （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.
Experimental: wearing noise cancelling headphones group; group started wearing noise cancelling headphones until the end of the surgery in the general anesthesia induction group to isolate intraoperative environmental noise	Other: noise cancelling headphones; The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6, 12, and 24 hours postoperatively
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).	at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	within 24 hours postoperatively
total opioid consumption		within 24 hours postoperatively
the number of PCIA pump buttons		within 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Investigators: Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): May 12, 2025
• Study Completion (Estimated): December 12, 2026

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: MCHH_011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No