Music Listening for Stress

No longer recruiting at 2 trial locations

Overseen By Nicole Mangione, BM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Hearing impairments

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of music affect stress levels in nursing students. Participants will listen to both calming and energizing music to observe each type's impact on the body's stress response. The trial includes two groups: one listens to calming music first, then energizing music, while the other reverses the order. Ideal candidates are nursing students in their junior, senior, or second-semester sophomore year, or those in an accelerated program, without hearing problems. As an unphased trial, this study provides a unique opportunity to contribute to understanding stress management through music.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this music listening protocol is safe for nursing students?

Research has shown that listening to music, whether calming or energizing, is generally safe. Studies have found that calming music can reduce anxiety without harm. For example, one study found that music significantly lowers stress both physically and mentally.

Calming music, often used for relaxation, effectively reduces anxiety and stress. While it might not always alter physical stress signs, it helps people feel less anxious. Energizing music, which is more upbeat, also reduces stress and improves mental well-being.

Overall, music therapy, including both calming and energizing music, is considered a safe way to manage stress and anxiety. No major reports of negative effects exist, making it a well-tolerated option for stress relief. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Music Listening for Stress trial because it explores a non-invasive and drug-free method to manage stress, which is different from standard treatments like medication or therapy. This trial investigates the effects of two types of music: sedative music and stimulative music. Unlike typical stress treatments that might take weeks to show results, music could potentially offer immediate calming or energizing effects. Additionally, this trial could reveal how different sequences of music can optimize stress relief, providing a unique approach to personalizing stress management techniques.

What evidence suggests that this trial's treatments could be effective for stress?

Research has shown that listening to music can greatly affect stress levels. In this trial, participants will experience different sequences of music to assess their effects on stress. Some studies indicate that calm music, which participants in one arm will receive first, can lower stress and anxiety by up to 65%. This type of music helps reduce stress in both the body and mind. Conversely, upbeat music, which participants in the other arm will receive first, can boost emotional strength and improve overall well-being. Both calm and upbeat music offer stress-reducing benefits, making them promising options for managing stress. ^{3 6 7 8 9}

Who Is on the Research Team?

Teresa Lesiuk, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for nursing students in their sophomore, junior, or senior year of a traditional BSN program or those enrolled in an accelerated BSN program. Students with self-reported hearing impairments cannot participate.

Inclusion Criteria

A student in the accelerated BSN program

I am in my sophomore, junior, or senior year of a BSN program.

Exclusion Criteria

Self-reported hearing impairments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants listen to sedative and stimulative music in two sessions, each session lasting up to 25 minutes, with a two-day gap between sessions

1 week

2 sessions (in-person)

Follow-up

Participants are monitored for changes in heart rate, skin conductance, and anxiety levels

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Sedative Music
• Stimulative Music

Trial Overview

The study investigates how listening to sedative music (calming) versus stimulative music (energizing) affects stress levels and physiological responses in nursing students.

How Is the Trial Designed?

Group I: Stimulative music followed by sedative music group Experimental Treatment 2 Interventions

The participants in this group will receive stimulative music followed by sedative music for up to 25 minutes each. Session two will occur two days after session one.

Group II: Sedative music followed by stimulative music group Experimental Treatment 2 Interventions

The participants in this group will receive sedative music followed by stimulative music for up to 25 minutes each. Session two will occur two days after session one.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a pilot study involving 20 mechanically ventilated ICU patients, listening to music significantly increased sedation scores, indicating that patients were less responsive to external stimuli compared to those who rested without music.

Despite the increase in sedation scores, there were no significant changes in physiological parameters like blood pressure or heart rate, suggesting that music is a safe intervention that does not negatively impact the patients' condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music on physiological responses and sedation scores in sedated, mechanically ventilated patients. Dijkstra, BM., Gamel, C., van der Bijl, JJ., et al.[2011]

A panel of music therapy experts evaluated 10 CD recordings for their relaxation qualities, ultimately selecting 10 musical pieces that were deemed most effective for a relaxation program aimed at parents in a pediatric hospital setting.

The study involved both experts and nonmusicians rating the relaxation quality of the music, leading to recommendations for specific musical selections that could enhance relaxation during stressful hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music for relaxation: a comparison of musicians and nonmusicians on ratings of selected musical recordings. Wolfe, DE., O'Connell, AS., Waldon, EG.[2019]

In a study of 113 older adults (ages 55-79) with ADHD, 65% reported a positive response to stimulant medication, indicating its potential efficacy in this age group.

While stimulant use was generally safe, 42% of patients discontinued due to side effects or lack of response, and there were small but significant changes in weight and heart rate, highlighting the need for careful cardiovascular monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response and Side Effects Using Stimulant Medication in Older Adults With ADHD: An Observational Archive Study. Michielsen, M., Kleef, D., Bijlenga, D., et al.[2021]

A systematic review of 26 placebo-controlled trials involving 811 adults found that methylphenidate is generally well tolerated for treating ADHD, with no serious side effects reported in the short term.

While methylphenidate can cause a modest increase in blood pressure and heart rate, there is limited information on its long-term safety in adults, and reports of serious adverse effects have been low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of therapeutic methylphenidate in adults: a systematic review of the evidence. Godfrey, J.[2018]

In a study involving 75 patients undergoing surgery, those who listened to music experienced significantly lower anxiety levels compared to those exposed to white noise or ambient noise, both before surgery and during recovery.

Patient satisfaction was highest in the music group, suggesting that allowing patients to choose music can enhance their overall experience during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music, white noise, and ambient noise on sedation and anxiety in patients under spinal anesthesia during surgery. Ilkkaya, NK., Ustun, FE., Sener, EB., et al.[2022]

Determining whether findings from nonclinical safety studies are adverse can be challenging due to variability in biological responses, leading to subjective interpretations by stakeholders involved in drug development.

The article presents a practical stepwise approach to assess adversity in drug treatment effects, supported by insights from various experts and illustrated through 10 case studies, highlighting the complexities in evaluating safety during pharmaceutical development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Considerations in Determining Adversity and the No-Observed-Adverse-Effect-Level (NOAEL) in Nonclinical Safety Studies: Challenges, Perspectives and Case Studies. Kale, VP., Bebenek, I., Ghantous, H., et al.[2022]

Listening to music significantly improves sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI), with an average improvement of -1.15 points per week over a 3-week period in studies comparing music to other interventions.

Longer music interventions, beyond 3 weeks, may lead to even better sleep outcomes, especially for individuals with mild sleep issues, by helping to replace poor bedtime habits with a positive association between music and sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music on Prescription to Aid Sleep Quality: A Literature Review. Dickson, GT., Schubert, E.[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]

In a study involving 20 pregnant women undergoing elective caesarean delivery, listening to Mozart sonatas during the procedure did not significantly improve patient satisfaction compared to a control group without music.

There were no notable differences in anxiety levels or post-operative mean arterial pressure between the music and control groups, suggesting that music may not have a meaningful impact in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Mozart music on patient satisfaction during caesarean delivery: a randomised controlled trial. Drzymalski, DM., Dahlawi, M., Hall, RR., et al.[2023]

A systematic review of 10 population-based studies found that while most studies in children and adolescents did not link prescription stimulant use to adverse cardiovascular events, some studies in adults indicated a potential increased risk for serious outcomes like transient ischemic attack and sudden death.

The evidence regarding the safety of prescription stimulants is mixed, highlighting the need for further research to address methodological issues and better understand the risks, especially in adult populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do prescription stimulants increase the risk of adverse cardiovascular events?: A systematic review. Westover, AN., Halm, EA.[2021]

In a study of 30 women with fibromyalgia, music listening was found to enhance perceived control over pain, particularly when the music was positive and used for activation or relaxation, although it did not reduce pain intensity itself.

The beneficial effects of music listening on pain control were not linked to changes in biological stress markers like cortisol, suggesting that the mechanisms behind these effects may be psychological rather than physiological.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music listening on pain and stress in the daily life of patients with fibromyalgia syndrome. Linnemann, A., Kappert, MB., Fischer, S., et al.[2020]

A comprehensive analysis of 104 randomized controlled trials involving 9,617 participants found that music interventions significantly reduce stress, with moderate effects on both physiological (d = 0.380) and psychological (d = 0.545) outcomes.

The analysis revealed that music interventions were particularly effective in lowering heart rate (d = 0.456), suggesting that physiological measures may respond more strongly to music than other stress indicators like blood pressure and hormone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. de Witte, M., Spruit, A., van Hooren, S., et al.[2022]

Stimulants, which enhance alertness and mood, cannot be easily classified by their chemical structure or effects, making their evaluation for abuse potential complex and multifaceted.

Recent advances in human abuse potential studies, such as larger sample sizes and improved measurement strategies, have made it challenging to compare new stimulant-like drugs with historical data, potentially leading to biases in regulatory assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human abuse liability evaluation of CNS stimulant drugs. Romach, MK., Schoedel, KA., Sellers, EM.[2014]

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]

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