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 (MUSIC-OR)
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
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
-
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Instrumental Music Group
Participants randomized to this group will receive instrumental music through headphones during surgery under general anesthesia.
Music playback will begin after induction of anesthesia and continue throughout the surgical procedure.
Standard anesthesia management will be maintained for all participants.
|
|
Noise Reduction Group
Participants randomized to this group will undergo surgery under general anesthesia in an operating room where environmental noise is minimized using a standardized noise reduction protocol.
Standard anesthesia management will be maintained for all participants.
|
|
Routine Care Control Group
Participants randomized to this group will receive standard perioperative care and general anesthesia without any additional acoustic intervention, music exposure, or noise reduction measures.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intraoperative Sevoflurane Consumption
Lasso di tempo: From induction of anesthesia until completion of surgery (up to 4 hours)
|
Total intraoperative sevoflurane consumption will be measured using average MAC values and total volatile anesthetic consumption recorded by the anesthesia machine during the surgical procedure.
|
From induction of anesthesia until completion of surgery (up to 4 hours)
|
|
Intraoperative Anesthetic and Opioid Consumption
Lasso di tempo: From induction of anesthesia until completion of surgery (up to 4 hours)
|
Total intraoperative sevoflurane consumption and opioid requirement will be recorded throughout the surgical procedure.
Sevoflurane consumption will be assessed using average MAC values and total volatile anesthetic use recorded by the anesthesia machine.
Opioid requirement will be assessed as the total intraoperative opioid dose administered per kilogram of body weight.
Outcomes will be compared among the instrumental music, noise reduction, and routine care groups.
|
From induction of anesthesia until completion of surgery (up to 4 hours)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intraoperative Sevoflurane Consumption
Lasso di tempo: From induction of anesthesia until completion of surgery (up to 4 hours)
|
Total intraoperative sevoflurane consumption will be measured using average minimum alveolar concentration (MAC) values and total volatile anesthetic consumption recorded by the anesthesia machine throughout the surgical procedure.
|
From induction of anesthesia until completion of surgery (up to 4 hours)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- E. Kurul-E2-26-14703
- TABED 1-26-2457 (Altro identificatore: ANKARA BİLKENT CİTY HOSPİTAL)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .