Music Therapy for Critical Illness

Overseen By Zachary Henry

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Neuromuscular blockers

Disqualifiers: Deafness, Musicogenic epilepsy, COVID-19, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 days

171 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how listening to music can reduce stress and pain in children on breathing machines in the pediatric intensive care unit (PICU). Researchers compare the effects of live music (music therapy), recorded music, and usual care on these children. Children who have been intubated (using a tube to assist with breathing) and are expected to remain in the PICU for more than three days might be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of innovative methods to improve care for children in critical conditions.

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 prior data suggests that music therapy is safe for children receiving mechanical ventilation?

Research has shown that music therapy is generally safe for seriously ill patients. Studies have found that both live and recorded music can reduce anxiety, pain, and stress without causing harm. For instance, one study noted that patients in intensive care units (ICUs) responded well to music therapy, feeling more relaxed and comfortable.

Another study discovered that live music might be more effective than recorded music at reducing pain and anxiety, though both are safe options. These findings suggest that music therapy is a safe method for managing stress and pain in seriously ill patients, without significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of music therapy for critical illness because it offers a non-invasive, drug-free option that could enhance patient care. Unlike traditional treatments that often rely on medication and machinery, music therapy taps into the soothing power of music to potentially reduce stress and anxiety in critically ill patients. By using both live and recorded music, this approach can be tailored to individual patient preferences, providing a personalized experience. Importantly, this method could improve patient outcomes by promoting relaxation and emotional well-being, which are crucial during critical illness.

What evidence suggests that this trial's music therapy treatments could be effective for stress and pain in critically ill children?

Research has shown that music therapy, whether live or recorded, can reduce stress and improve the quality of life for very sick patients. This trial will explore both live and recorded music interventions. One study found that live music therapy lowered heart and breathing rates and reduced discomfort in children. Another study suggested that longer music sessions, especially those focused on pain relief, significantly lessened pain. Recorded music also reduced anxiety in patients using breathing machines. However, evidence suggests that live music might be more effective than recorded music in easing pain and anxiety in children. Overall, music therapy could be a helpful tool for managing stress and pain in intensive care settings. ^{2 6 7 8 9}

Who Is on the Research Team?

Jessica M Jarvis, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children aged 5-17 who are intubated and on mechanical ventilation in the PICU, expected to stay over 72 hours. It's not for kids whose caregiver can't communicate in English, those with bilateral deafness, musicogenic epilepsy, COVID-19 diagnosis, new traumatic brain injury or unlikely to survive their PICU stay.

Inclusion Criteria

I am between 2 months and 17 years old.

Expected to have a Pediatric Intensive Care Unit (PICU) stay of more than 72 hours

I am on a breathing machine.

Exclusion Criteria

My child is deaf, has music-triggered seizures, and is getting muscle relaxant infusions.

My child was recently admitted for a new brain injury.

My child has been diagnosed with COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive live and recorded music interventions to assess effects on stress and pain biomarkers

3 days

Daily sessions in the pediatric intensive care unit

Follow-up

Participants are monitored for changes in stress and pain biomarkers post-intervention

1 month

Interviews conducted within 1 month of completing primary data collection

What Are the Treatments Tested in This Trial?

Interventions

• Live music
• Recorded music

Trial Overview The study aims to compare how live and recorded music affect stress and pain indicators in ventilated children at the PICU. Each child will experience both interventions randomly during their stay to see which one works better.

How Is the Trial Designed?

Group I: Usual care > Recorded music > Live music Experimental Treatment 3 Interventions

Order of conditions for the day

Group II: Usual Care > Live music > Recorded music Experimental Treatment 3 Interventions

Order of conditions for the day

Group III: Recorded music > Usual care > Live music Experimental Treatment 3 Interventions

Order of conditions for the day

Group IV: Recorded music > Live music > Usual care Experimental Treatment 3 Interventions

Order of conditions for the day

Group V: Live music > Usual Care > Recorded music Experimental Treatment 3 Interventions

Order of conditions for the day

Group VI: Live music > Recorded music > Usual Care Experimental Treatment 3 Interventions

Order of conditions for the day

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Music listening interventions can effectively reduce anxiety and promote relaxation in critically ill patients on mechanical ventilation, highlighting its potential as a therapeutic tool in critical care settings.

Engaging a music therapist is crucial for assessing patient music preferences and implementing tailored music listening protocols, allowing patients to actively manage their anxiety during challenging medical experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instituting a music listening intervention for critically ill patients receiving mechanical ventilation: Exemplars from two patient cases. Heiderscheit, A., Chlan, L., Donley, K.[2021]

In a study of 118 adult ICU patients on mechanical ventilation, live music therapy significantly reduced agitation and heart rate compared to standard care, indicating its efficacy in managing anxiety and physiological responses.

Patients receiving live music therapy showed improved scores on agitation and pain scales, suggesting that music therapy can be a beneficial intervention for intubated patients in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit. Golino, AJ., Leone, R., Gollenberg, A., et al.[2023]

Music interventions can effectively reduce anxiety and promote relaxation in critically ill patients, particularly those in intensive care units (ICUs).

The Music Assessment Tool (MAT) was developed to help healthcare professionals identify patients' music preferences, facilitating personalized music therapy even for patients who have communication difficulties due to medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Tool for Music Preference Assessment in Critically Ill Patients Receiving Mechanical Ventilatory Support. Chlan, L., Heiderscheit, A.[2021]

Music therapy serves as a complementary treatment for critically ill patients in intensive care, enhancing the effects of conventional medical treatments.

The intervention has both physiological and psychological benefits, suggesting it can improve overall patient well-being during critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in ICU. Coughlan, A.[2015]

Music therapy is effective in reducing anxiety and managing stress for critically ill patients, making it a valuable intervention in clinical settings.

The MAIT (Music and Arts in Healthcare) resource allows nurses to implement music therapy by enabling patients to choose their preferred music and negotiate listening times, which enhances their sense of control in a stressful hospital environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in critical care: indications and guidelines for intervention. Chlan, L., Tracy, MF.[2007]

This study aims to systematically review the effects of music listening on sleep and psychological outcomes, such as anxiety and depression, in critically ill patients, using a comprehensive search of multiple scientific databases and including randomized controlled trials.

The primary focus will be on sleep-related outcomes, with a rigorous methodology to assess study quality and risk of bias, ensuring reliable results that could inform non-pharmacological interventions in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of music to enhance sleep and psychological outcomes in critically ill patients: a protocol for a systematic review and meta-analysis. Chen, L., Wang, F., Li, J., et al.[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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03948984

Assessing the Impact of LIve Music in the Intensive Care ... Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain The ...

2. news.uhhospitals.org news.uhhospitals.org/news-releases/articles/2025/09/large-study-finds-certain-music-therapy-interventions-may-be-more-beneficial-for-pain

Large Study Finds Certain Music Therapy Interventions May ... Additionally longer music therapy sessions and those documented with an explicit goal of managing pain were more likely to reduce pain ≥2 units.

3. bmjopen.bmj.com bmjopen.bmj.com/content/11/5/e037561

Use of music to enhance sleep and psychological ... We will assess whether music listening improves sleep and psychological outcomes in critically ill patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202193/

Impact of Music Therapy on Patients in the Critical Care Unit This study delves into music therapy as a promising intervention that alleviates stress, fosters emotional expression and enhances patients' quality of life.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1036731423000103

The effect of a live music therapy intervention on critically ill ... Live music therapy results in reduced heart rates, breathing rates, and paediatric patient discomfort levels.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1036731424002029

Live music in the intensive care unit—A mixed-methods ... This study aimed to explore the experience of live music in adult patients admitted to an ICU, focusing on its effects on relaxation, stress, and pain.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3212751/

Instituting a music listening intervention for critically ill patients ... Music is an ideal intervention to reduce anxiety and promote relaxation in critically ill patients receiving mechanical ventilatory support.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8566759/

Music, mental health, and immunity - PMC - PubMed Central Utilising music as a structured intervention in treating mental illnesses such as anxiety, depression and schizophrenia has been reported as beneficial in ...

9. withpower.com withpower.com/trial/phase-critical-illness-6-2022-9474f

Therapeutic Music Sessions for Critical Illness Research shows that therapeutic music is generally safe for critically ill patients, helping to reduce anxiety, pain, and stress without harmful effects. Show ...