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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic Requirement. Basic parameters: 1 year — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EFFECT OF INTRAOPERATİVE INSTRUMENTAL MUSİC AND OPERATİNG ROOM NOİSE REDUCTİON ON ANESTHETİC AND ANALGESİC REQUİREMENTS İN PEDİATRİC PATİENTS AGED 3-18 YEARS UNDERGOİNG SURGERY UNDER GENERAL ANESTHESİA: A RANDOMİZED CONTROLLED TRİAL
Overview
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.
Detailed description
This study is a prospective, single-center, three-arm randomized controlled trial including pediatric patients aged 3-18 years who are scheduled for elective surgery under general anesthesia.
Participants will be randomly assigned to one of three groups: intraoperative instrumental music, operating room noise reduction, or routine care. In the music group, instrumental music will be delivered through headphones during surgery. In the noise reduction group, operating room noise will be minimized using a standardized acoustic management approach. The routine care group will receive standard anesthesia care without an additional acoustic intervention.
General anesthesia will be managed according to a standardized protocol. Anesthetic depth, hemodynamic variables, anesthetic consumption, opioid use, postoperative pain, emergence delirium, and recovery room stay will be recorded and compared between groups.
The study is designed to investigate whether simple non-pharmacological acoustic interventions during surgery can reduce anesthetic and analgesic requirements and improve early postoperative recovery in children.
Primary outcome measures
- Intraoperative Sevoflurane Consumption [Time frame: From induction of anesthesia until completion of surgery (up to 4 hours)]
- Intraoperative Anesthetic and Opioid Consumption [Time frame: From induction of anesthesia until completion of surgery (up to 4 hours)]
Secondary outcome measures (1)
- Intraoperative Sevoflurane Consumption [Time frame: From induction of anesthesia until completion of surgery (up to 4 hours)]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07630675 · E. Kurul-E2-26-14703 · TABED 1-26-2457