Emergence DeliriumPhase 1/2DEAP MusicNCT06236477
Decreasing Emergence Delirium With Personalized Music
A Phase 1/2 study testing Personalized Music and No Music in people with Emergence Delirium, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Personalized Music and No Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2024to 28 Mar 2026
- Phase
- Phase 1/2
- 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 3-9 years
- Presenting for unilateral or bilateral myringotomy under GA
Who cannot join
- Combined procedures
- Lack of interest in music (e.g., child who does not have musical preferences)
- Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
- Parent/guardian or patient refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.
Read the detailed description
Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale.
Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.
- Conditions
- Emergence Delirium
- Being tested
- Personalized Music, No Music
- Keywords
- Anesthesia, Music, Pediatric Anesthesia, Emergence Delirium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized MusicBehavioural
Music that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care
No MusicBehavioural
Participants will receive standard care without music.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Music Group | Active comparator | Those assigned to receive music will be asked to provide a short list of 5-10 songs familiar/well-known to the patient (specifically the song title and artist for each song). Songs will be downloaded onto an electronic mp3 player by the research staff member. The mp3 player will then be provided along with a portable Bluetooth speaker for use during the patient's perioperative period, loaded with the songs of their choice. Receives: Behavioral: Personalized Music |
| No Music Group | Placebo comparator | Those not assigned to the personalized music group will receive standard care without music. Receives: Behavioral: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium Scale
Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome
Measured: day of surgery
Secondary outcomes (6)
The modified Yale Preoperative Anxiety Scale
Assessment scale for preoperative anxiety. Raw score 5-22; adjusted score range 23.33-100; higher scores indicates a worse outcome
Measured: day of surgery
Wong-Baker Faces Pain Rating Scale
Pain scale. Range 0-10, higher score indicates a worse outcome
Measured: day of surgery
Face, Legs, Activity, Cry, Consolability scale
Pain scale. Range 0-10, higher score indicates a worse outcome
Measured: day of surgery
Induction Compliance Checklist
Assessment scale for anxiety during mask induction of anesthesia. Range 0-10, higher score indicates a worse outcome
Measured: day of surgery
Satisfaction survey
Survey of parental satisfaction with perioperative care. A qualitative survey with discrete questions that contain "yes" or "no" or likert-style ratings ranging from "strongly disagree" to "strongly agree."
Measured: day of surgery
Post Hospitalization Behavior Questionnaire
Parental assessment of behavioral changes following surgery. Range 27-135, higher score indicates a worse outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start26 Jan 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel-group, superiority randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Society for Pediatric Anesthesia
- Responsible party
- Principal investigator, Benjamin A Sanofsky, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236477
- Sponsor's protocol ID
- 202309122
- Acronym
- DEAP Music
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2024
- Last updated
- 23 Jul 2026
- Results posted
- 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Emergence Delirium With Personalized Music
- ClinicalTrials.gov ID
- NCT06236477
- Acronym / sponsor ID
- DEAP Music / 202309122
- Conditions
- Emergence Delirium
- Keywords
- Anesthesia, Music, Pediatric Anesthesia, Emergence Delirium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Society for Pediatric Anesthesia
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 1 Feb 2024 (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 is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.
Detailed description
Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale.
Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 parallel-group, superiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Personalized Music Group | Active comparator | Behavioral: Personalized MusicThose assigned to receive music will be asked to provide a short list of 5-10 songs familiar/well-known to the patient (specifically the song title and artist for each song). Songs will be downloaded onto an electronic mp3 player by the research staff member. The mp3 player will then be provided along with a portable Bluetooth speaker for use during the patient's perioperative period, loaded with the songs of their choice. |
| No Music Group | Placebo comparator | Behavioral: No MusicThose not assigned to the personalized music group will receive standard care without music. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child aged 3-9 years
- Presenting for unilateral or bilateral myringotomy under GA
Key exclusion criteria (4 listed)
- Combined procedures
- Lack of interest in music (e.g., child who does not have musical preferences)
- Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
- Parent/guardian or patient refusal
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 |
|---|---|---|
| Personalized MusicMusic that is familiar to the child will be played via bluetooth speaker throughout their immediate perioperative care | Behavioural | Personalized Music Group |
| No MusicParticipants will receive standard care without music. | Behavioural | No Music Group |
Primary outcome
Pediatric Anesthesia Emergence Delirium Scale
Time frame: day of surgery
Assessment scale for emergence delirium.Range 0-20, higher score indicates a worse outcome
6 secondary outcomes
The modified Yale Preoperative Anxiety Scale
Time frame: day of surgery
Wong-Baker Faces Pain Rating Scale
Time frame: day of surgery
Face, Legs, Activity, Cry, Consolability scale
Time frame: day of surgery
Induction Compliance Checklist
Time frame: day of surgery
Satisfaction survey
Time frame: day of surgery
Post Hospitalization Behavior Questionnaire
Time frame: 1 year
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 23 Jul 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 Phase 1/2 study testing Personalized Music and No Music in people with Emergence Delirium, run by Washington University School of Medicine at 1 site in United States.
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 2 inclusion and 4 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 23 Jul 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pediatric Anesthesia Emergence Delirium Scale (time frame: day of 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 23 Jul 2026.