100 Participants NeededMy employer runs this trial

Music Therapy for Anxiety

SA
Overseen ByShyamal Asher, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rhode Island Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy can reduce anxiety and increase comfort for patients undergoing a transcatheter aortic valve replacement (TAVR). Participants will either listen to music through headphones during their surgery or join a control group without music. Candidates may qualify if they are scheduled for an elective TAVR at Rhode Island Hospital, do not require general anesthesia, and can respond to questions about their anxiety. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing patient comfort during heart procedures.

What prior data suggests that music therapy is safe for patients undergoing TAVR procedures?

Research has shown that music therapy is generally safe and well-tolerated. Many studies have explored its effects on anxiety and reported positive results. Several trials, for instance, discovered that music therapy can significantly reduce anxiety and stress. In these studies, patients felt less anxious after listening to music, with no negative side effects.

One study found that music therapy helped lower anxiety symptoms in college students compared to those who did not receive the therapy. Experts agree that when conducted correctly, music therapy should not cause harm.

Overall, evidence suggests that music therapy is a safe option for reducing anxiety, making it a low-risk choice for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Researchers are excited about using music therapy for anxiety because it offers a non-invasive and drug-free alternative to traditional treatments like medication and cognitive-behavioral therapy. Unlike typical treatments that can take time to show effects or may come with side effects, music therapy has the potential to soothe patients almost instantly by leveraging the calming effects of music. Plus, it's accessible and can be easily integrated into various settings, such as before or after surgery, which might help reduce anxiety without additional medications.

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

Research has shown that music therapy can help reduce anxiety. One study found that college students who received music therapy experienced significantly lower anxiety levels than those who did not. Another study discovered that music noticeably reduced stress, often linked to anxiety. Additionally, parents and caregivers reported that music therapy effectively lowered anxiety in children. In this trial, participants in the Music Group will receive music therapy during surgery, while the Control Group will not. Overall, these findings suggest that music therapy could be a promising way to ease anxiety during medical procedures like transcatheter aortic valve replacement (TAVR).12567

Who Is on the Research Team?

SA

Shyamal Asher, MD

Principal Investigator

Brown University Health

Are You a Good Fit for This Trial?

This trial is for people undergoing a transcatheter aortic valve replacement (TAVR) procedure. Specific inclusion and exclusion criteria are not listed, but generally it targets patients scheduled for TAVR who may experience anxiety during the operation.

Inclusion Criteria

I am able to answer questions about my anxiety.
I am scheduled for a transfemoral TAVR with monitored anesthesia at Rhode Island Hospital.

Exclusion Criteria

I need an urgent TAVR procedure.
Significant hearing impairment that would preclude ability to hear music via headphones
Documented severe claustrophobia or inability to tolerate headphones
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo TAVR procedure with or without music therapy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for anxiety and satisfaction postoperatively

24 hours
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Music Therapy

Trial Overview

The study compares listening to music during the TAVR procedure versus no music at all, to see if music helps reduce patient anxiety and improve comfort. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Music GroupActive Control1 Intervention
Group II: Control Group (No music)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials
275
Recruited
71,400+

Citations

Music therapy for the treatment of anxiety: a systematic review ...

These findings support the use of music therapy as an effective intervention for reducing anxiety, with inclusive but promising effects on physiological ...

Music therapy for stress reduction: a systematic review and ...

Results showed that music therapy showed an overall medium-to-large effect on stress-related outcomes (d = .723, [.51–.94]). Larger effects were found for ...

Effectiveness of music-based therapy on adolescents and ...

For instance, studies suggest that music therapy can significantly alleviate anxiety and depression in children with special needs (Bradt & Dileo, 2014).

A Quantitative Study of Music Therapy and Anxiety

The results confirmed that after clinical instrumental and vocal improvisation, participants' anxiety symptoms significantly decreased by Week 6 of treatment.

The efficacy of music therapy in alleviating anxiety among ...

The results indicated that, compared to the control group, Music therapy (MT) significantly alleviated anxiety symptoms among college students. The mechanisms ...

Effect of music intervention on anxiety in critically ill ...

Overall, current evidence does not support music therapy as an effective stand-alone intervention for anxiety reduction in critically ill patients. Further ...

Music therapy found to significantly reduce pain, stress and ...

As part of clinical care, the music therapists assessed patients' self-reported pain, stress, and anxiety on a 0 to 10 scale at the beginning ...