Relaxing Music for Pre-operative Stress

Overseen By Nancy R Jarbadan, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Hearing impairments, Substance abuse, Anxiety, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether listening to relaxing music before surgery can reduce stress. The researchers aim to determine if music can lower heart rate, blood pressure, and breathing rate as patients undergo anesthesia. Participants will either listen to calming music through headphones or wear headphones without music. The trial seeks children aged 10 to 16 undergoing surgery for bone or joint issues, with consent required from both the child and their guardian.

As an unphased trial, this study provides a unique opportunity to contribute to understanding how music might ease surgical stress in young patients.

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

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

What prior data suggests that this method is safe for reducing pre-operative stress?

Research has shown that listening to relaxing music before surgery can reduce anxiety and stress. Studies have found that music therapy effectively lowers anxiety levels in patients. Listening to music is safe, with no reports of serious side effects. Some studies investigated issues like nausea, dizziness, or headaches but found no significant problems.

Overall, using music to calm patients before surgery is both safe and helpful. It can make patients feel more relaxed without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using relaxing music to ease pre-operative stress because it offers a non-invasive and drug-free approach to anxiety management. Unlike typical treatments that involve medications like benzodiazepines, which can have side effects, this method uses calming music delivered through noise-cancelling headphones as a natural way to help patients relax. This innovative technique could enhance patient comfort without the need for additional pharmaceuticals, making it a promising option for those seeking alternative stress reduction strategies before surgery.

What evidence suggests that relaxing music is effective for reducing pre-operative stress?

Research has shown that listening to relaxing music can reduce anxiety before surgery. One study found that calming music eased pre-surgery anxiety more effectively than medication. Another study also demonstrated that music lowers anxiety in busy hospital settings. A meta-analysis, which combines results from several studies, confirmed that music can reduce anxiety and pain around surgery time. In this trial, participants will either listen to relaxing music or wear noise-cancelling headphones without music during induction. Overall, evidence suggests that listening to relaxing music helps patients feel calmer before surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Carolyn Barbieri, MD

Principal Investigator

Penn State College of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients and guardians are English-speaking

I am between 10 and 16 years old.

Consent to participate in the study obtained from both the guardian and child

Exclusion Criteria

I have hearing problems or ear issues.

Pre-existing issues with substance abuse, anxiety, or depression

Pre-existing psychiatric disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Music Intervention

Participants listen to pre-selected calming music through noise-cancelling headphones prior to and during induction of anesthesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stress levels and vital signs post-intervention

1 day

What Are the Treatments Tested in This Trial?

Interventions

• No Music
• Relaxing Music

Trial Overview 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.

How Is the Trial Designed?

Group I: Relaxing Music Experimental Treatment 1 Intervention

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

Group II: No Music Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

Music has the potential to decrease pain perception during minor surgical procedures, suggesting a non-pharmacological approach to pain management.

The study indicates that incorporating music into surgical settings could enhance patient comfort and reduce reliance on pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music proves therapeutic to pain levels. [2019]

A systematic review of 42 randomized controlled trials found that music interventions can significantly reduce anxiety and pain in perioperative patients, with positive effects observed in about half of the studies.

Given the low cost and potential benefits of music therapy, further research is encouraged to better understand its mechanisms and enhance patient care in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anxiety- and pain-reducing effects of music interventions: a systematic review. Nilsson, U.[2022]

Music significantly reduces anxiety levels in patients undergoing plastic surgery, with a standardized mean difference of -3.64, indicating a strong effect compared to no music intervention.

While music did not show a statistically significant effect on pain reduction (mean difference of -12.06), it remains a safe and cost-effective option for enhancing patient comfort during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Music in a Plastic Surgery Setting: A Systematic Review and Meta-analysis. Zapata-Copete, JA., Cordoba-Wagner, MJ., García-Perdomo, HA.[2023]

Citations

1. nature.com nature.com/articles/s41598-025-16413-7

Effect of music intervention on preoperative anxiety, a ... A randomized controlled study has shown that relaxing music can effectively alleviate preoperative patient anxiety, even more than orally ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366122/

Music intervention as a strategy to reduce preoperative anxiety Music intervention is a promising strategy to alleviate preoperative anxiety levels and is easily implementable even in busy clinical settings.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6175460/

Meta‐analysis evaluating music interventions for anxiety and ... This study aimed to evaluate anxiety and pain following perioperative music interventions compared with control conditions in adult patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1089947225003387

Effectiveness of Music Intervention on Perioperative ... This study aimed to provide a preliminary evaluation of the effectiveness of music intervention on perioperative anxiety and physiological ...

5. journals.lww.com journals.lww.com/jpbs/fulltext/2024/16005/effects_of_music_therapy_and_deep_relaxation.146.aspx

Effects of Music Therapy and Deep Relaxation Techniques ... The study found that both music therapy and DRT can effectively reduce perioperative anxiety in patients undergoing spinal surgeries.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888618/

Effects of Music Therapy and Deep Relaxation Techniques for ... The study found that both music therapy and DRT can effectively reduce perioperative anxiety in patients undergoing spinal surgeries.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04813978

The Effect of Music Therapy on Preoperative Anxiety in ... Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety. J Vasc Nurs. 2013 Sep;31(3): ...