Personalized Music for Delirium

(DEAP Music Trial)

Overseen By Joel Hanns

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Washington University School of Medicine

Disqualifiers: Combined procedures, Lack of interest, others

Compensation: Varies

Number of Visits: 3

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Personalized Music for Delirium?

Research shows that music interventions can help reduce the risk of delirium in older and critically ill patients, with studies indicating beneficial effects in preventing delirium. A meta-analysis found that music reduced the risk of delirium in postsurgical and critically ill older patients. ^{1 2 3 4 5}

Is personalized music therapy safe for humans?

Personalized music therapy has been used in various clinical settings, including intensive care units and for patients recovering from surgery, without reports of harm. It is generally considered safe and can help manage stress, anxiety, and delirium without the adverse effects associated with some medications. ^{2 3 6 7 8}

How is personalized music therapy different from other treatments for delirium?

Personalized music therapy is unique because it uses music tailored to the individual's preferences to help manage delirium, unlike standard treatments that often rely on medications. This non-drug approach aims to improve attention and awareness by engaging patients emotionally and cognitively, potentially reducing the incidence and severity of delirium without the side effects associated with medications. ^{1 2 3 4 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

Lack of interest in music (e.g., child who does not have musical preferences)

I am undergoing multiple medical procedures together.

Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Personalized Music Group Active Control 1 Intervention

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.

Group II: No Music Group Placebo Group 1 Intervention

Those not assigned to the personalized music group will receive standard care without music.

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+

Findings from Research

A randomized controlled trial involving 52 patients in an intensive care unit found that personalized music and slow-tempo music were well-accepted, with 80% of participants enjoying the music, compared to only 30% in the attention control group.

While the study did not show a significant difference in delirium-free days or severity between the music groups and the attention control group, the high adherence rates suggest that music could be a feasible nonpharmacological intervention for managing delirium in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing Delirium Through Music: A Randomized Pilot Trial. Khan, SH., Xu, C., Purpura, R., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 189 adult patients undergoing craniotomy, listening to preferred recorded music was associated with a lower incidence of delirium as measured by the Delirium Observation Screening Scale (11.6% in the music group vs. 22.3% in the control group), suggesting a potential benefit of music in reducing delirium risk.

Although the initial findings indicated a reduction in delirium incidence, this was not confirmed by DSM-5 criteria, highlighting the need for further validation of delirium screening tools and the importance of evaluating long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial. Kappen, PR., Mos, MI., Jeekel, J., et al.[2023]

This systematic review aims to evaluate the effects of music therapy on delirium in ICU patients receiving mechanical ventilation, addressing a gap in knowledge about non-pharmacological interventions for this common condition.

The study will analyze randomized controlled trials and is expected to provide evidence-based insights into whether music therapy can effectively reduce the duration, incidence, and severity of delirium in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music therapy on delirium in patients receiving mechanical ventilatory support in the Intensive Care Unit: A protocol for systematic review and meta-analysis. Zhou, C., Ma, H., Qi, X., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 126 mechanically ventilated patients in intensive care units, preferred music playlists were analyzed to understand their impact on managing anxiety through patient-directed music listening interventions.

The findings highlight the importance of music selection in therapeutic interventions, suggesting that involving a board-certified music therapist can enhance the effectiveness of music listening protocols in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. Heiderscheit, A., Johnson, K., Chlan, LL.[2023]

The Positive Stimulation for Medically Sedated Patients (PSMSP) protocol, which includes personalized music and family storytelling, may help reduce agitation and improve arousal in ICU patients recovering from sedation, potentially mitigating sedation-related delirium.

This nonpharmacologic approach offers a structured intervention that could be safer than pharmacologic treatments, which often lead to oversedation and adverse effects, highlighting the need for critical care teams to incorporate such therapies into patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Stimulation for Medically Sedated Patients: A Music Therapy Intervention to Treat Sedation-Related Delirium in Critical Care. Head, J., Gray, V., Masud, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial investigating the effect of music therapy during an acute psychotic episode. Morgan, K., Bartrop, R., Telfer, J., et al.[2011]

Music therapy has shown potential benefits for psychotic patients, particularly in enhancing communication skills, which appears to stem more from the interpersonal dynamics of active improvisation rather than structured training.

The therapy may positively influence self-perception and ego strength in patients with schizophrenia, suggesting that music can play a role in their emotional and cognitive development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of psychotic patients with music therapy]. Inselmann, U.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Decreasing Delirium Through Music: A Randomized Pilot Trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Music Interventions and Delirium in Adults: A Systematic Literature Review and Meta-Analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Music to prevent deliriUm during neuroSurgerY (MUSYC): a single-centre, prospective randomised controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of music therapy on delirium in patients receiving mechanical ventilatory support in the Intensive Care Unit: A protocol for systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of music on sedation, analgesia and delirium in critically ill patients. A systematic review of randomized controlled trials. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of Preferred Music of Mechanically Ventilated Intensive Care Unit Patients Enrolled in a Randomized Controlled Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Positive Stimulation for Medically Sedated Patients: A Music Therapy Intervention to Treat Sedation-Related Delirium in Critical Care. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A controlled trial investigating the effect of music therapy during an acute psychotic episode. [2011]

9. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of psychotic patients with music therapy]. [2016]