Music Exposure for Anxiety

Overseen By Nishanth Ganeshbabu, BS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Tufts Medical Center

Must not be taking: Anti-anxiolytics

Disqualifiers: Impaired hearing, no anxiety, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how listening to music can reduce anxiety and stress. Researchers aim to determine if varying lengths of music exposure, known as music therapy, affect calming nerves, particularly for individuals scheduled for elective cesarean deliveries. Participants will either listen to music or not, allowing for a comparison of effects. Ideal candidates for this trial are those scheduled for a planned C-section, experiencing anxiety, and not currently taking anxiety medication. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of music therapy for anxiety relief.

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 anti-anxiety medication daily, you cannot participate.

What prior data suggests that music exposure is safe for anxiety treatment?

Research has shown that listening to music is generally safe. Studies have found that music can reduce anxiety and stress without causing harm. A review found that music therapy can improve both mental and physical health, positively affecting heart rate and mood without negative side effects.

Music often supports mental health and has improved mood and overall well-being. No serious adverse reactions have been reported from simply listening to music. Therefore, participating in a study involving music listening is likely to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music exposure for anxiety because it takes a non-invasive and natural approach to calming the mind, unlike standard treatments such as medication or therapy. While traditional anxiety treatments often rely on pharmaceuticals that can have side effects, music exposure offers a drug-free alternative that can be easily integrated into daily life. Additionally, the use of music can be personalized, allowing individuals to select tunes that resonate with them, potentially enhancing the therapeutic effect. This innovative approach could provide a more accessible and enjoyable way to manage anxiety symptoms, appealing to those seeking holistic or complementary options.

What evidence suggests that music exposure might be an effective treatment for anxiety?

Research shows that listening to music can help reduce anxiety. In this trial, participants in the Music Exposure arm will listen to music for a specified duration. A review of several studies has found that music therapy significantly lowers anxiety levels compared to not using music therapy. Another study found that music therapy had a noticeable positive effect on stress. These findings suggest that listening to music might improve emotional well-being by reducing stress and anxiety. Overall, existing research supports the idea that music can be a useful tool for managing anxiety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 who are scheduled for an elective cesarean delivery and can give informed consent. It's not specified who cannot join, but typically those with conditions affecting hearing or stress responses might be excluded.

Inclusion Criteria

Elective scheduled cesarean delivery

Able to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Patient demographic data and baseline vital signs, including anxiety levels, are recorded

1 day

1 visit (in-person)

Music Exposure

Participants listen to varying durations of music to assess anxiety reduction

Up to 60 minutes per session

1 visit (in-person)

Control Exposure

Participants experience a period of no music to assess anxiety levels

Up to 60 minutes per session

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety, blood pressure, and heart rate post-exposure

Up to 60 minutes after exposure

What Are the Treatments Tested in This Trial?

Interventions

• Music Exposure

Trial Overview

The study is looking at how different lengths of music exposure affect anxiety and satisfaction in patients. Participants will listen to music for varying durations before their procedure to see if it helps reduce stress.

How Is the Trial Designed?

Group I: Music Exposure Experimental Treatment 1 Intervention

Patient will listen to a specified duration of music.

Group II: No-Music Exposure Active Control 1 Intervention

Patient will not listen to music to for specified duration of time.

Music Exposure is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Music Therapy for:

• Anxiety
• Depression
• Stress Relief
• Pain Management

Approved in United States as Music Therapy for:

• Anxiety Disorders
• Depressive Disorders
• Post-Traumatic Stress Disorder (PTSD)
• Chronic Pain

Approved in Canada as Music Therapy for:

• Anxiety
• Depression
• Stress Management
• Rehabilitation

Approved in Japan as Music Therapy for:

• Anxiety Disorders
• Depressive Disorders
• Dementia
• Physical Rehabilitation

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Published Research Related to This Trial

In a study of 60 breast cancer patients undergoing radiotherapy, those who listened to algorithmically created music (Melomics-Health group) showed significant improvements in anxiety and psychological distress compared to the no music group.

The individualized music listening group experienced mixed results, with initial worsening in anxiety and distress scores, highlighting that not all music interventions may have the same positive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional and Algorithmic Music Listening before Radiotherapy Treatment: A Randomized Controlled Pilot Study. Raglio, A., Oddone, E., Meaglia, I., et al.[2021]

In a study involving 98 cancer patients undergoing chemotherapy, music therapy was found to significantly reduce post-chemotherapy anxiety more effectively than verbal relaxation or usual care, particularly benefiting those with high state anxiety.

Both music therapy and verbal relaxation were effective in alleviating anxiety, but music therapy also led to an increase in skin temperature, suggesting a physiological response that may enhance patient comfort during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of the effect of music therapy and verbal relaxation on chemotherapy-induced anxiety. Lin, MF., Hsieh, YJ., Hsu, YY., et al.[2011]

Music therapy significantly reduces anxiety levels compared to control groups, with a moderate effect size (SMD = -0.36) observed immediately after treatment in a meta-analysis of 32 studies involving 1,924 participants.

The positive effects of music therapy on anxiety were noted across different age groups and in both developed and developing countries, but the benefits did not persist at follow-up, indicating a need for further research on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety: A meta-analysis of randomized controlled trials. Lu, G., Jia, R., Liang, D., et al.[2021]

A study of 788 university students identified six main reasons for listening to music, with Anxiety Sensitivity (AS) linked to using music for Coping and Conformity, which help relieve negative emotions.

The findings suggest that individuals with higher AS may use music as a tool for emotional regulation, highlighting the potential for music therapy to support those at risk for anxiety and related mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for Listening to Music Vary by Listeners' Anxiety Sensitivity Levels. Pridy, CB., Watt, MC., Romero-Sanchiz, P., et al.[2022]

Receptive music therapy, applied over 16 weekly sessions to 10 patients, showed a trend towards reduced stress levels and increased personal satisfaction, indicating its potential effectiveness in improving emotional well-being.

Participants also reported healthier lifestyle changes, such as increased intake of fiber-rich foods and decreased consumption of cholesterol-rich foods, suggesting that music therapy can positively influence health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of receptive music therapy in internal medicine and cardiology. Marconato, C., Munhoz, EC., Menim, MM., et al.[2019]

Music Therapy (MT) has shown potential in improving social and emotional well-being, particularly for individuals dealing with social anxiety, a prevalent mental health issue.

Incorporating ethnic music into therapy could enhance the effectiveness of music therapy, highlighting the need for strategies to integrate MT into public health programs to better address social anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music Therapy and Public Health: How to Bridge the Use of Ethnic Music for Social Anxiety. Arizona, A., Hanurawan, F., Hidayah, N., et al.[2023]

In a study involving 163 participants taking anxiolytics, combining calm music with theta auditory beat stimulation (ABS) was found to significantly reduce both somatic and cognitive state anxiety, especially in those with moderate trait anxiety.

Participants with moderate trait anxiety experienced the greatest benefits from the combined treatment, while music alone also showed effectiveness compared to a control group, indicating that sound-based therapies can be a valuable tool for anxiety management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial. Mallik, A., Russo, FA.[2022]

Active music therapy, when integrated with cognitive-behavioral therapy (CBT) group counseling, effectively reduced academic anxiety in participants after two weeks of treatment.

The study utilized a quasi-experimental design with repeated measures, indicating that the positive effects of the therapy were observed not only immediately after treatment but also during follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral-Active Music Pastoral Therapy for Millennials' Academic Anxiety: How & Why? Situmorang, DDB.[2021]

Executive music therapy (EMT) significantly reduced state anxiety levels in 64 hospitalized psychiatric patients, indicating its potential as an effective intervention for immediate anxiety relief (P < .05).

However, EMT did not have a significant impact on trait anxiety levels, suggesting that while it can help with short-term anxiety, it may not address long-term anxiety traits (P > .05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of executive music therapy on state and trait anxiety levels of patients in a psychiatric ward: A quasi-experimental study. Bahadir-Yilmaz, E.[2021]

In a clinical trial involving 120 female breast cancer patients, music therapy significantly reduced state anxiety levels compared to routine nursing care alone, with lower anxiety scores observed at three different post-test measurements.

The study demonstrated that music therapy can be an effective complementary intervention for managing anxiety in patients following radical mastectomy, highlighting its potential role in holistic cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. Li, XM., Zhou, KN., Yan, H., et al.[2022]

Music therapy and music medicine have been shown to have positive effects on children and adolescents with various psychiatric disorders, including mood/anxiety disorders and substance abuse, highlighting their potential as effective treatment options.

The article discusses the need for further research to better understand the mechanisms of action and to strengthen the evidence base for music therapy in psychiatric treatment, while also providing practical suggestions for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy and music medicine for children and adolescents. Yinger, OS., Gooding, L.[2022]

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]

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