Effect of Intraoperative Instrumental Music and Operating Room Noise Reduction on Anesthetic and … (NCT07630675) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Intraoperative Instrumental Music and Operating Room Noise Reduction on Anesthetic and Analgesic Requirements in Pediatric Patients Aged 3-18 Years Undergoing Surgery Under General Anesthesia: A Randomized Controlled Trial
180 participantsStarted 2026-06-01
Plain-language summary
This randomized controlled clinical trial aims to evaluate the effects of intraoperative instrumental music and operating room noise reduction on anesthetic and analgesic requirements in pediatric patients aged 3-18 years undergoing elective surgery under general anesthesia.
A total of 180 patients will be randomly assigned to one of three groups: an instrumental music group, a noise reduction group, or a routine care control group. In the music group, patients will be exposed to instrumental music through headphones during surgery. In the noise reduction group, operating room noise levels will be minimized using a standardized acoustic management protocol. The control group will receive standard anesthetic care without any acoustic intervention.
All patients will undergo standardized general anesthesia. The primary outcomes will be intraoperative volatile anesthetic consumption (sevoflurane use and MAC values) and opioid requirements. Secondary outcomes will include hemodynamic parameters, postoperative pain scores, emergence delirium, and post-anesthesia care unit (PACU) length of stay.
The study does not involve any experimental drugs, invasive procedures, or additional risks beyond routine clinical care. The findings may help determine whether simple non-pharmacological acoustic interventions can reduce anesthetic and analgesic requirements and improve perioperative outcomes in pediatric patients.
Who can participate
Age range
1 Year – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:Children aged 3 to 18 years Scheduled for elective surgery under general anesthesia American Society of Anesthesiologists (ASA) physical status I or II Expected surgical duration between 30 minutes and 4 hours Eligibility for standardized general anesthesia management No contraindication to the use of headphones or acoustic interventions Written informed consent obtained from a parent or legal guardian Assent obtained from children when appropriate according to age and cognitive capacity -
Exclusion Criteria: Emergency surgery ASA physical status III or higher Significant neurological disorders or developmental delay Severe cognitive impairment preventing appropriate assessment Epilepsy or disorders associated with increased sensitivity to auditory stimulation Moderate to severe hearing impairment or active ear disease Chronic use of opioids, sedatives, or psychoactive medications Severe cardiac, hepatic, or renal dysfunction Refusal of participation by the parent, legal guardian, or patient
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Sevoflurane Consumption
Timeframe: From induction of anesthesia until completion of surgery (up to 4 hours)
2
Intraoperative Anesthetic and Opioid Consumption
Timeframe: From induction of anesthesia until completion of surgery (up to 4 hours)