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

NCT06918470 | Recruiting DMC

• 1 other identifier: MCHH_011
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Noise Cancelling Headphones; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• maximum resting pain score

  within 24 hours postoperatively

• total opioid consumption

  within 24 hours postoperatively

• the number of PCIA pump buttons

  within 24 hours postoperatively

Study Arms (2)

Conventional processing group,

SHAM COMPARATOR

Standard monitoring techniques ,Conventional processing without noise cancelling headphones

Other: Standard monitoring techniques

wearing noise cancelling headphones group

EXPERIMENTAL

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

Interventions

Standard monitoring techniques OTHER

（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.

Conventional processing group,

noise cancelling headphones OTHER

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.

wearing noise cancelling headphones group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province,

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Na Li, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

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: March 28, 2025
• First Posted: April 9, 2025
• Study Start: February 12, 2025
• Primary Completion: May 12, 2025
• Study Completion (Estimated): December 12, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)