What is the mechanism of action of this treatment?

Common treatments for anxiety, such as cognitive-behavioral therapy (CBT) and mind-body practices like music therapy, work by altering cognitive processes and promoting relaxation. CBT helps patients identify and change negative thought patterns and behaviors that contribute to anxiety. Mind-body practices, including music therapy, use sensory stimulation to induce a state of relaxation and reduce stress. These treatments are important for anxiety patients because they provide non-pharmacological options that can effectively manage symptoms, improve emotional regulation, and enhance overall quality of life.

What side effects are associated with this type of intervention?

Common non-pharmacological treatments for anxiety include music therapy, cognitive behavioral therapy (CBT), and mindfulness-based practices. Music therapy, specifically, has minimal side effects, with the primary concern being the potential for temporary discomfort if the music is not to the patient's liking. CBT and mindfulness practices are generally safe but may cause initial emotional discomfort as patients confront anxiety-provoking thoughts and feelings. Overall, these treatments are well-tolerated and have fewer side effects compared to pharmacological options.

What prior FDA approvals exist?

FDA-approved pharmacologic treatments for anxiety disorders include selective serotonin reuptake inhibitors (SSRIs) such as sertraline and fluoxetine, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine, and benzodiazepines such as alprazolam and diazepam. These medications have been shown to be effective in reducing anxiety symptoms. In contrast, music therapy, which aims to reduce stress and anxiety through auditory stimulation, represents a non-pharmacologic approach and is not FDA-approved as a treatment for anxiety but may be used as a complementary therapy.

What other types of research exist?

Promising novel alternatives to music therapy for anxiety patients include: 1) Digital therapeutics, such as apps providing goal-based counseling and personalized sound therapy, which have shown superior outcomes in clinical trials. 2) Cognitive Behavioral Therapy (CBT), including internet-based CBT, which has been effective in reducing anxiety symptoms. 3) Mindfulness-Based Stress Reduction (MBSR), an evidence-based program using meditation practices to manage anxiety. 4) Biofeedback and neurofeedback, which have shown potential in reducing anxiety by training patients to control physiological functions. 5) Guided imagery and progressive muscle relaxation, which have been effective in reducing anxiety and improving overall well-being.

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Relaxing Music for Pre-operative Stress

N/A

Recruiting

Led By Carolyn Barbieri, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 10 - 16 years

Present to the OR for correction of an orthopedic complaint not involving the head or neck

Must not have

Hearing impairments or ear abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests if listening to calming music through headphones can reduce stress in children undergoing surgery. The music aims to lower heart rate, blood pressure, and breathing rate, making the experience less stressful.

Who is the study for?

This trial is for English-speaking children aged 10-16 who are having orthopedic surgery not involving the head or neck. Both the child and guardian must agree to participate. It's not for those with hearing issues, substance abuse, anxiety, depression, or psychiatric disorders.

What is being tested?

The study tests if playing relaxing music through noise-cancelling headphones before anesthesia can lower stress levels by reducing heart rate, blood pressure, and breathing rate during this period.

What are the potential side effects?

Since this trial involves listening to music as an intervention, there are no direct medical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 16 years old.

Select...

I am going for surgery to fix a bone or joint problem not in my head or neck.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have hearing problems or ear issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Relaxing MusicExperimental Treatment1 Intervention

Participants will listen to relaxing music through noise-cancelling headphones during induction.

Group II: No MusicActive Control1 Intervention

Participants will wear noise-cancelling headphones during induction but no music will be played through them.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for anxiety, such as cognitive-behavioral therapy (CBT) and mind-body practices like music therapy, work by altering cognitive processes and promoting relaxation. CBT helps patients identify and change negative thought patterns and behaviors that contribute to anxiety. Mind-body practices, including music therapy, use sensory stimulation to induce a state of relaxation and reduce stress. These treatments are important for anxiety patients because they provide non-pharmacological options that can effectively manage symptoms, improve emotional regulation, and enhance overall quality of life.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

504 Previous Clinical Trials

2,795,728 Total Patients Enrolled

5 Trials studying Anxiety

375 Patients Enrolled for Anxiety

Carolyn Barbieri, MDPrincipal InvestigatorPenn State College of Medicine

Media Library

Anxiety Research Study Groups: Relaxing Music, No Music

No Music 2023 Treatment Timeline for Medical Study. Trial Name: NCT02870517 — N/A

~4 spots leftby Dec 2024

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