160 Participants Needed

Personalized Music for Delirium

(DEAP Music Trial)

Recruiting at 1 trial location
BS
JH
Overseen ByJoel Hanns
Age: < 18
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Washington University School of Medicine

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether personalized music can reduce emergence agitation (restlessness and confusion) in children after ear tube surgery. Children aged 3 to 9 undergoing this surgery at Washington University will either listen to their favorite songs during the procedure or receive standard care without music. Ideal participants enjoy music and are scheduled for this specific ear surgery. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works and measure its effectiveness in an initial, smaller group of children, offering participants a chance to contribute to innovative care improvements.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that personalized music therapy is likely to be safe for children undergoing myringotomies?

Research shows that using music in medical settings is generally safe and well-received. Studies have found that listening to music in hospitals can lower heart rates, blood pressure, and stress levels, indicating a calming effect on the body.

One study discovered that slow-tempo music significantly reduced the risk of delirium, a sudden state of confusion, in intensive care patients. This finding encourages the use of music in medical settings, as it shows potential benefits without harm.

Additionally, a review of music interventions found that patients who listened to music had a lower risk of developing delirium compared to those who did not. This supports the idea that music can safely enhance medical care and improve patient outcomes.

Overall, evidence suggests that music interventions are safe in medical environments, with no significant negative effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about using personalized music for delirium because it offers a non-invasive and patient-centered approach. Unlike standard treatments that often rely on medications, personalized music therapy leverages familiar songs to create a calming effect, potentially reducing the symptoms of delirium without the side effects associated with drugs. This approach not only taps into the emotional and memory centers of the brain but also empowers patients by involving them in their care, making it a unique and promising alternative to traditional methods.

What evidence suggests that personalized music might be an effective treatment for emergence agitation?

Research shows that listening to music can help reduce symptoms of delirium. Studies have found that patients experience fewer delirium episodes when they listen to music, especially slow-tempo music. Although not every study found strong results, a consistent trend of improvement in delirium symptoms with music has emerged. Overall, music has been linked to less severe delirium and fewer negative effects. In this trial, participants in the Personalized Music Group will receive music tailored to their preferences, which might help children undergoing surgery by reducing emergence agitation, a condition similar to delirium.23678

Are You a Good Fit for This Trial?

This trial is for children aged 3-9 who are having ear tube surgery (myringotomies) at Washington University in St. Louis. The study aims to see if listening to personalized music can help prevent confusion or agitation when waking up from anesthesia.

Inclusion Criteria

My child, aged 3-9, is scheduled for ear surgery under general anesthesia.

Exclusion Criteria

I am undergoing multiple medical procedures together.
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)
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Assessment of preoperative anxiety using the modified Yale Preoperative Anxiety Scale and Induction Compliance Checklist

Day of surgery
1 visit (in-person)

Perioperative Treatment

Participants receive either personalized music or standard care during the perioperative period to assess emergence agitation

Day of surgery
1 visit (in-person)

Postoperative Assessment

Assessment of postoperative pain and satisfaction using various scales including the Face, Legs, Activity, Cry, Consolability scale and Wong-Baker Faces Pain Rating Scale

Day of surgery
1 visit (in-person)

Follow-up

Behavioral changes assessed using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized Music
Trial Overview The trial is testing the effect of personalized music played during and after surgery against no music, focusing on how it might reduce the chances of kids experiencing emergence delirium—a state of confusion and agitation as they wake up from anesthesia.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Personalized Music GroupActive Control1 Intervention
Group II: No Music GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

The Society for Pediatric Anesthesia

Collaborator

Trials
4
Recruited
5,000,000+

Published Research Related to This Trial

Music interventions (MIs) may significantly reduce the incidence of delirium in older, critically ill patients, with a summary relative risk of 0.47 indicating a strong potential benefit compared to standard care.
The review included 12 studies, with 6 in the meta-analysis, highlighting that while most studies reported positive effects of music on delirium prevention, there is a need for better-designed research to explore specific patient subgroups and the relationship between different types of music interventions and delirium symptoms.
Music Interventions and Delirium in Adults: A Systematic Literature Review and Meta-Analysis.Golubovic, J., Neerland, BE., Aune, D., et al.[2023]
In a study of 60 participants experiencing acute psychotic episodes, music therapy as an adjunct to standard pharmacological treatment showed a statistically significant improvement in Brief Psychiatric Rating Scale (BPRS) scores for the treatment group compared to the control group.
Although the treatment group experienced a 9.3% reduction in hospital stay length, this finding was not statistically significant, suggesting that while music therapy may benefit some patients, its overall impact on hospitalization and other psychological assessments remains inconclusive.
A controlled trial investigating the effect of music therapy during an acute psychotic episode.Morgan, K., Bartrop, R., Telfer, J., et al.[2011]
A systematic review of six studies involving critically ill adults found limited evidence supporting the use of music for reducing sedation and analgesia requirements, with only one study showing a potential benefit.
Overall, the review concluded that there is insufficient evidence to confirm the effectiveness of music in reducing delirium in critically ill patients, and no studies were found involving pediatric or neonatal populations.
Efficacy of music on sedation, analgesia and delirium in critically ill patients. A systematic review of randomized controlled trials.Garcia Guerra, G., Almeida, L., Zorzela, L., et al.[2020]

Citations

Music Interventions and Delirium in Adults - PubMed CentralAlthough not statistically significant, their results showed a trend towards improvement in delirium symptoms and suggested that researcher- ...
'Pre-recorded Music Interventions on Delirium in ...Most included studies found both a reduction of delirium events, and more frequently negative delirium assessment outcomes following music ...
Dose–response analysis of music intervention for ...This study provides evidence that music intervention, especially slow-tempo music, significantly reduces the risk of delirium in ICU patients.
Decreasing Delirium through Music (DDM) in critically ill ...Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity. Trial registration.
A systematic review of the comparative effects of sound ...The aim of this study was to summarise and contrast available evidence on the effect of music and nonmusic sound interventions for the physiological and ...
Decreasing Delirium Through Music: A Randomized Pilot ...In hospitals, listening to music has been associated with lower heart rates, blood pressures, and serum cortisol levels, and less anxiety, ...
Music Interventions and Delirium in Adults: A Systematic ...The summary relative risk for incident delirium comparing music vs. no music in postsurgical and critically ill older patients was 0.52 (95% ...
A randomized pilot and feasibility trial of live and recorded ...This randomised pilot and feasibility trial tested feasibility, acceptability, fidelity, and safety of music interventions (MIs) for delirium patients.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security