Clinical trial NCT06918470: Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain
Official title: Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain During Gynecological Laparoscopic Surgery ：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Noise Cancelling Headphones
Postoperative Pain
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

-

Primary outcomes:
measure: pain scores
timeFrame: 6, 12, and 24 hours postoperatively
measure: maximum pain scores
timeFrame: at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively.
Secondary outcomes:
measure: maximum resting pain score
timeFrame: within 24 hours postoperatively
measure: total opioid consumption
timeFrame: within 24 hours postoperatively
measure: the number of PCIA pump buttons
timeFrame: within 24 hours postoperatively
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province,
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References: