General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic RequirementMUSIC-ORNCT07630675
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
An observational study of General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic Requirement, run by Ankara City Hospital Bilkent.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic Requirement
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of pediatric patients aged 3 to 18 years who are scheduled to undergo elective surgical procedures under general anesthesia at a tertiary care university-affiliated hospital. Eligible participants will have ASA physical status I or II and will be recruited during the preoperative evaluation period. Patients undergoing emergency surgery or presenting with conditions that may interfere with the study interventions or outcome assessments will be excluded.
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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About this study
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
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.
Read more
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.
Read the 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.
- Keywords
- Pediatric Anesthesia, General Anesthesia, Instrumental Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Sevoflurane Consumption
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.
Measured: From induction of anesthesia until completion of surgery (up to 4 hours)
Intraoperative Anesthetic and Opioid Consumption
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.
Measured: From induction of anesthesia until completion of surgery (up to 4 hours)
Secondary outcomes (1)
Intraoperative Sevoflurane Consumption
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.
Measured: From induction of anesthesia until completion of surgery (up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic RequirementStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630675
- Sponsor's protocol ID
- E. Kurul-E2-26-14703
- Other IDs
- TABED 1-26-2457
- Acronym
- MUSIC-OR
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07630675
- Acronym / sponsor ID
- MUSIC-OR / E. Kurul-E2-26-14703
- Keywords
- Pediatric Anesthesia, General Anesthesia, Instrumental Music
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of pediatric patients aged 3 to 18 years who are scheduled to undergo elective surgical procedures under general anesthesia at a tertiary care university-affiliated hospital. Eligible participants will have ASA physical status I or II and will be recruited during the preoperative evaluation period. Patients undergoing emergency surgery or presenting with conditions that may interfere with the study interventions or outcome assessments will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative Sevoflurane Consumption
Time frame: 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.
Intraoperative Anesthetic and Opioid Consumption
Time frame: 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.
1 secondary outcome
Intraoperative Sevoflurane Consumption
Time frame: From induction of anesthesia until completion of surgery (up to 4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic Requirement, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Sevoflurane Consumption (time frame: From induction of anesthesia until completion of surgery (up to 4 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.