Music Listening for Stress

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

34 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Sedative Music, Relaxing Music, Calming Music, Soothing Music, Stimulative Music, Stimulative Music Therapy, Music Intervention, Relaxation Music for stress?

Research shows that music listening can help reduce anxiety and promote relaxation in patients, including those in intensive care or undergoing surgery. Music is a low-cost way to improve patient satisfaction and manage stress, especially when tailored to individual preferences. ^{1 2 3 4 5}

Is listening to music for stress relief safe for humans?

There is no specific safety data available for music listening as a treatment for stress, but generally, listening to music is considered safe for humans. ^{6 7 8 9 10}

How does music listening for stress differ from other treatments?

Music listening for stress is unique because it uses personalized music selections to help manage stress and anxiety, unlike other treatments that might involve medication or therapy sessions. This approach allows individuals to choose music that they find relaxing or uplifting, which can enhance the effectiveness of the intervention by making it more personally meaningful and enjoyable. ^{1 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.

Research Team

Teresa Lesiuk, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

A student in the accelerated BSN program

Exclusion Criteria

Self-reported hearing impairments

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. 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]

2. Poland pubmed.ncbi.nlm.nih.gov

The effect of Mozart music on patient satisfaction during caesarean delivery: a randomised controlled trial. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Instituting a music listening intervention for critically ill patients receiving mechanical ventilation: Exemplars from two patient cases. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The effects of music on physiological responses and sedation scores in sedated, mechanically ventilated patients. [2011]

5. United States 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. [2022]

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

Do prescription stimulants increase the risk of adverse cardiovascular events?: A systematic review. [2021]

7. United States 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. [2022]

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

Response and Side Effects Using Stimulant Medication in Older Adults With ADHD: An Observational Archive Study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Human abuse liability evaluation of CNS stimulant drugs. [2014]

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

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of music listening on pain and stress in the daily life of patients with fibromyalgia syndrome. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Effects of music interventions on stress-related outcomes: a systematic review and two meta-analyses. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Music on Prescription to Aid Sleep Quality: A Literature Review. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Music for relaxation: a comparison of musicians and nonmusicians on ratings of selected musical recordings. [2019]