Personalized Music for Emergence Agitation

Recruiting at 4 trial locations

Overseen By Jyoti Bhamidipati, MBBS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Sedatives, Analgesics

Disqualifiers: Hearing loss, Lack of music interest, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

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—confusion and restlessness after waking from anesthesia—in children post-surgery. Personalized music therapy might lower anxiety and pain, promoting a smoother recovery. Participants will either listen to their favorite music before and after surgery or receive standard care without music. Children aged 3-9 undergoing specific surgeries, such as ear tube placement or tonsil removal, may be suitable candidates. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative music therapy during recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking any sedative or pain-relieving medications regularly, you may not be eligible to participate.

What prior data suggests that personalized music is safe for pediatric patients?

Research has shown that personalized music is generally safe in medical settings. In one study, critically injured adults in intensive care found personalized music helpful for managing stress and accepted it well. Another study found that 80% of intensive care patients felt comfortable with personalized music.

These findings suggest that listening to music is usually safe and comfortable for patients. While the current study focuses on children undergoing surgery, earlier research in adults indicates that personalized music might safely help reduce anxiety and restlessness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for emergence agitation, which typically involves medications and monitoring, personalized music offers a non-pharmacological approach tailored to individual patients' preferences. This treatment uses music to potentially soothe and calm patients both before and after surgery, making it unique in its delivery method. Researchers are excited because this method could reduce reliance on sedatives and minimize side effects, offering a more holistic and patient-centered care experience.

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

Research has shown that personalized music can reduce feelings of restlessness and anxiety. One study found that playing music tailored to an individual about 30 minutes before their peak restlessness can be beneficial. Other studies suggest that personalized music can ease distressing symptoms and improve mood. It also helps people feel more connected to themselves and experience joy. While results can vary, evidence indicates that music interventions can positively impact health. In this trial, participants in the Personalized Music arm will receive music alongside standard care, which may help calm children after surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

R J Ramamurthi, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children aged 3-9 undergoing specific surgeries like tonsillectomy or myringotomy, who enjoy music. It's not for kids with significant hearing loss, no interest in music, on chronic sedatives or analgesics, having combined procedures not listed, or if they experience surgical complications.

Inclusion Criteria

I have had ear surgery, laser skin treatment, or adenoid removal without tonsil removal.

I have had my tonsils removed, with or without adenoid removal.

I am between 3 and 9 years old.

Exclusion Criteria

I don't enjoy music or can't identify music that is meaningful to me.

I am having a surgery that is not mentioned in the study's listed procedures.

I have had complications from surgery or anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants receive personalized music or standard care in the preoperative holding area. Anxiety is assessed using the modified Yale Preoperative Anxiety Scale (mYPAS).

20 minutes

1 visit (in-person)

Intra-operative

Standardized anesthetic procedures are administered. Mask acceptance is assessed using the Induction Compliance Checklist (ICC).

5 minutes

Post-operative

Participants are assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scores. Pain and parental satisfaction are also evaluated.

45 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Music

Trial Overview The study tests whether personalized music can reduce 'emergence agitation'—confusion and restlessness—as kids wake up from anesthesia after surgery. Half will get their favorite tunes plus usual care; the other half just gets usual care.

How Is the Trial Designed?

Group I: Personalized Music Experimental Treatment 1 Intervention

Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit in addition to standard care.

Group II: Standard of Care Active Control 1 Intervention

Those assigned to the Standard of Care arm will only receive standard of care in the preoperative holding area as well as in the post-operative care unit

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of Vermont Medical Center

Collaborator

Trials

46

Recruited

25,900+

Published Research Related to This Trial

Individualized music interventions have been clinically evaluated and refined into an evidence-based protocol, showing efficacy in reducing agitation and promoting positive interactions in various settings, including long-term care facilities and home environments.

Research indicates that the use of individualized music not only decreases agitation but also enhances overall well-being, leading to positive emotions and meaningful connections, highlighting its potential as a holistic therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized music for dementia: Evolution and application of evidence-based protocol. Gerdner, LA.[2021]

A group music intervention program consisting of 12 sessions over 4 weeks was found to be feasible and acceptable for individuals with dementia, with 63.2% of participants experiencing a reduction in agitation.

The study involved 19 participants with a mean age of 82.74, indicating that music-based interventions may effectively help manage agitation in memory care settings, warranting further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Group Music Intervention in Memory Care Communities. Veal, BM., Dobbs, D., Lee, S., et al.[2022]

A music intervention significantly reduced anxiety levels in hospitalized psychiatric patients across different anxiety levels, as shown by a study involving 22 participants who listened to music for 20 minutes daily over 10 days.

The intervention also resulted in notable changes in brain activity, measured by electroencephalogram, indicating its potential effectiveness as a low-cost strategy for managing anxiety in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a researcher designated music intervention on hospitalised psychiatric patients with different levels of anxiety. Yang, CY., Miao, NF., Lee, TY., et al.[2018]

In a study involving 14 patients with severe traumatic brain injury (TBI), listening to preferred music significantly reduced agitation compared to classical 'relaxation' music, suggesting a potential therapeutic benefit.

The results indicate that using preferred music as an intervention could be an effective environmental strategy to help manage agitation in TBI patients, enhancing their safety and rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Preferred Music on Agitation After Traumatic Brain Injury. Park, S., Williams, RA., Lee, D.[2017]

A personalized music intervention significantly reduced the frequency of verbally agitated behaviors in nursing home residents with dementia, as observed in a study involving 976 participants across 54 facilities.

Residents receiving personalized music were also more likely to show signs of pleasure compared to those receiving usual care, suggesting that music can positively impact mood in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Structured Observations to Evaluate the Effects of a Personalized Music Intervention on Agitated Behaviors and Mood in Nursing Home Residents With Dementia: Results From an Embedded, Pragmatic Randomized Controlled Trial. Sisti, A., Gutman, R., Mor, V., et al.[2023]

Individualized music interventions showed potential in reducing agitation symptoms in some nursing home patients with severe dementia, as evidenced by calmer behavior in two out of four patients during music sessions.

The effectiveness of music therapy may depend on identifying individual music preferences, suggesting that personalized approaches could enhance its impact on anxiety and agitation in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized music played for agitated patients with dementia: analysis of video-recorded sessions. Ragneskog, H., Asplund, K., Kihlgren, M., et al.[2019]

A pilot study involving 21 hospitalized patients with dementia demonstrated that a personalized music listening intervention is feasible for nursing staff to implement in a geriatric unit, potentially enhancing patient engagement and clinical efficiency.

While the results on agitation reduction were inconclusive due to the small sample size, the study suggests that non-pharmacological approaches like music could challenge the reliance on psychotropic medications for managing agitation in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a personalised music listening intervention decrease agitation in hospitalised patients with dementia? A feasibility trial. Lee, S., Chan, L., Maddison, J.[2023]

The Restraint-Music Response Instrument (RMRI) was developed and tested for its ability to measure patient behaviors during musical interventions, showing it to be a valid and reliable tool based on assessments from both experts and actual patient observations.

The study indicates that musical interventions can influence the behavioral reactions of physically restrained patients, but further research with a control group is needed to fully understand the effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music for untying restrained patients. Janelli, LM., Kanski, G.[2004]

An individualized music listening program significantly reduced agitation in 21 patients with Alzheimer's disease and related dementias, as shown by a statistically significant decrease in scores on the Pittsburgh Agitation Scale (p<0.001).

The study highlights that music can effectively elicit positive emotions and reduce agitation in dementia patients, leveraging the brain's intact ability to recognize music despite cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individualized music listening program to reduce agitation in hospitalized patients with Alzheimer's disease and related dementias. Belenchia, EJ.[2023]

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 case study of a pediatric patient in post-traumatic amnesia revealed four distinct behavioral responses during music therapy: Neutral, Acceptance, Recruitment, and Rejection, highlighting the complexity of patient engagement.

While the quantitative analysis did not conclusively show a reduction in agitation, the study suggests that familiar songs can create 'Islands of Awareness,' potentially aiding cognitive rehabilitation in early recovery after traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for early cognitive rehabilitation post-childhood TBI: an intrinsic mixed methods case study. Bower, J., Catroppa, C., Grocke, D., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9256757/

Pragmatic Trial of Personalized Music for Agitation and ... Conclusions and Implications: Personalized music was not significantly effective in reducing agitated behaviors nor psychotropic drug use among long-stay ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224001212

Effects of Individualized Versus Classical "Relaxation ... Individualized music intervention is most effective when the intervention is implemented approximately 30 minutes prior to the peak level of agitation.

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/07334648241257797

A Personalized Music Intervention in Nursing Home ... This study provides evidence that the personalized music intervention can be used to manage distressing behavioral and psychological symptoms ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0312175

Personalized music for cognitive and psychological symptom ... Personalized music helped patients maintain their identity and process their trauma. Additional benefits of music included experiencing pleasure ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/12010/music_intervention_for_older_adults__evidence_map.77.aspx

Music Intervention for older adults: Evidence Map of... The study revealed that music interventions for older adults can have positive or potentially positive effects on health outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05044832

Decreasing Emergence Agitation With Personalized Music The purpose of the study is to assess the impact of personalized music on emergence agitation (EA), as measured by Pediatric Anesthesia Emergence Delirium ...

7. withpower.com withpower.com/trial/phase-2-delirium-2024-99305

Personalized Music for Delirium (DEAP Music Trial) 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 ...