Preoperative AnxietyNCT07877428
Effects of Music on Preoperative Anxiety and Emergence Delirium in Children
A study testing Music Group in people with Preoperative Anxiety and Emergence Delirium, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of classical music listening on preoperative anxiety and postoperative emergence delirium in children aged 9-12 years undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Preoperative Anxiety, Emergence Delirium
- What is being tested?
- Music Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 9-12 years Children classified as ASA physical status I or II Children scheduled to undergo an elective surgical procedure under general anesthesia Children with an estimated surgery duration of 1-3 hours Children without neurological disorders, chronic illnesses, or psychiatric diagnoses Children and their parents who agree to participate in the study
Who cannot join
- Children younger than 9 years or older than 12 years Children classified as ASA physical status III or higher Children scheduled for surgery lasting less than 1 hour or more than 3 hours Children with chronic, neurological, or psychiatric conditions Children scheduled to undergo surgery under local anesthesia Children undergoing emergency surgery Children with a history of prematurity or congenital disease Children with visual or hearing impairments that could interfere with the music intervention or study assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Anxiety and the Incidence of Postoperative Emergence Delirium in Children Exposed to Music
This randomized controlled trial aims to evaluate the effects of classical music listening on preoperative anxiety and postoperative emergence delirium in children aged 9-12 years undergoing elective surgery. Participants were randomly assigned in a 1:1 ratio to either a music intervention group or a control group receiving routine care. Children in the intervention group listened to classical music during the preoperative period and during emergence from anesthesia. Preoperative anxiety and the incidence and severity of emergence delirium were compared between the two groups.
- Conditions
- Preoperative Anxiety, Emergence Delirium
- Being tested
- Music Group
- Keywords
- Delirium, Anxiety
- Medical subject headings
- Emergence Delirium, Delirium, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music GroupBehavioural
Children in the intervention group listened to classical music during the preoperative period and again during emergence from anesthesia. The music intervention was provided in addition to routine perioperative care. Classical music was delivered using headphones, and the intervention was applied according to a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | Not described Receives: Behavioral: Music Group |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety
Preoperative anxiety will be assessed using the STAI. Higher scores indicate higher levels of anxiety. The total score ranges from 20 to 60.
Measured: Immediately before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Aug 2024
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Irem Aydin, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877428
- Sponsor's protocol ID
- BUU-MUSIC-2024-01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety and the Incidence of Postoperative Emergence Delirium in Children Exposed to Music
- ClinicalTrials.gov ID
- NCT07877428
- Acronym / sponsor ID
- BUU-MUSIC-2024-01
- Conditions
- Preoperative Anxiety, Emergence Delirium
- Keywords
- Delirium, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 16 Oct 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 trial aims to evaluate the effects of classical music listening on preoperative anxiety and postoperative emergence delirium in children aged 9-12 years undergoing elective surgery. Participants were randomly assigned in a 1:1 ratio to either a music intervention group or a control group receiving routine care. Children in the intervention group listened to classical music during the preoperative period and during emergence from anesthesia. Preoperative anxiety and the incidence and severity of emergence delirium were compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Behavioral: Music Group |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 9-12 years Children classified as ASA physical status I or II Children scheduled to undergo an elective surgical procedure under general anesthesia Children with an estimated surgery duration of 1-3 hours Children without neurological disorders, chronic illnesses, or psychiatric diagnoses Children and their parents who agree to participate in the study
Key exclusion criteria (1 listed)
- Children younger than 9 years or older than 12 years Children classified as ASA physical status III or higher Children scheduled for surgery lasting less than 1 hour or more than 3 hours Children with chronic, neurological, or psychiatric conditions Children scheduled to undergo surgery under local anesthesia Children undergoing emergency surgery Children with a history of prematurity or congenital disease Children with visual or hearing impairments that could interfere with the music intervention or study assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music GroupChildren in the intervention group listened to classical music during the preoperative period and again during emergence from anesthesia. The music intervention was provided in addition to routine perioperative care. Classical music was delivered using headphones, and the intervention was applied according to a standardized protocol. | Behavioural | Music Group |
Primary outcome
Preoperative Anxiety
Time frame: Immediately before surgery
Preoperative anxiety will be assessed using the STAI. Higher scores indicate higher levels of anxiety. The total score ranges from 20 to 60.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Group in people with Preoperative Anxiety and Emergence Delirium, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preoperative Anxiety (time frame: Immediately before surgery). 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 16 Oct 2026.