Personalized Music for Emergence Agitation

Recruiting at 3 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

Trial Summary

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 data supports the effectiveness of the treatment Personalized Music for reducing emergence agitation?

Research shows that personalized music can help reduce agitation in patients with traumatic brain injury and dementia. Studies found that listening to preferred music significantly decreased agitation compared to other types of music, suggesting it may be an effective way to calm patients. ^{1 2 3 4 5}

Is personalized music therapy safe for humans?

Research on personalized music therapy, including studies on traumatic brain injury and dementia, suggests it is generally safe for humans. These studies focus on reducing agitation and improving mood without reporting any harmful effects. ^{3 4 6 7 8}

How is personalized music therapy different from other treatments for emergence agitation?

Personalized music therapy is unique because it uses music that is specifically chosen based on the patient's personal preferences, which can be more effective in reducing agitation compared to generic relaxation music. Unlike medications, this non-drug approach avoids potential side effects and leverages the brain's natural response to familiar and enjoyable music to calm patients. ^{2 3 9 10 11}

What is the purpose of this trial?

The purpose of the study is to assess the impact of personalized music on emergence agitation (EA), as measured by Pediatric Anesthesia Emergence Delirium scores in pediatric patients recovering from elective procedures under general anesthesia. Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. The study has the potential to improve perioperative care by improving safety, decreasing the need for postoperative pharmacologic and nursing interventions, thereby shortening the time of recovery and improving caregiver satisfaction. Participants participating in this study will be randomly assigned to receive personalized music plus standard of care, or standard of care alone. Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit.

Research Team

R J Ramamurthi, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of a researcher designated music intervention on hospitalised psychiatric patients with different levels of anxiety. [2018]

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

Can a personalised music listening intervention decrease agitation in hospitalised patients with dementia? A feasibility trial. [2023]

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

Effect of Preferred Music on Agitation After Traumatic Brain Injury. [2017]

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

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

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

Feasibility and Acceptability of a Group Music Intervention in Memory Care Communities. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Music therapy for early cognitive rehabilitation post-childhood TBI: an intrinsic mixed methods case study. [2018]

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

Music for untying restrained patients. [2004]

8. 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]

9. England 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. [2023]

10. Australia pubmed.ncbi.nlm.nih.gov

Individualized music played for agitated patients with dementia: analysis of video-recorded sessions. [2019]

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

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