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

212 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Relaxing Music for Pre-operative Stress?

Research shows that music interventions can help reduce anxiety and stress in patients undergoing surgery. In about half of the studies reviewed, music was effective in lowering anxiety and pain, making it a promising low-cost option for reducing pre-operative stress. ^{1 2 3 4 5}

Is listening to relaxing music safe for reducing pre-operative stress?

Listening to music is generally safe and can help reduce anxiety and stress during surgical procedures, as shown in studies involving plastic surgery, cesarean sections, and other operations. It can lower heart rate and blood pressure, and reduce the need for sedatives, making it a low-risk option for managing pre-operative stress. ^{6 7 8 9 10}

How does relaxing music as a treatment for pre-operative stress differ from other treatments?

Relaxing music is unique because it offers a non-drug alternative to reduce anxiety before surgery, potentially avoiding the side effects associated with anxiolytic drugs (medications that reduce anxiety). Unlike medications, music therapy is non-invasive and can be easily administered without the need for medical supervision. ^{3 5 11 12 13}

Research Team

Carolyn Barbieri, MD

Principal Investigator

Penn State College of Medicine

Eligibility Criteria

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.

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

Exclusion Criteria

I have hearing problems or ear issues.

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

Pre-existing psychiatric disorders

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

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

Preoperative and perioperative music to reduce anxiety during first-time phacoemulsification cataract surgery in the high-volume setting: randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effect of music on preprocedure anxiety in Hong Kong Chinese day patients. [2019]

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

Effects of music intervention on inflammatory markers in critically ill and post-operative patients: A systematic review of the literature. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Relaxing intraoperative natural sound blunts haemodynamic change at the emergence from propofol general anaesthesia and increases the acceptability of anaesthesia to the patient. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Role of Music in a Plastic Surgery Setting: A Systematic Review and Meta-analysis. [2023]

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

Coping with preoperative anxiety in cesarean section: physiological, cognitive, and emotional effects of listening to favorite music. [2022]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

["Walkman music" during epidural anesthesia]. [2015]

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

Effects of music on patient anxiety. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The effects of a music intervention during port catheter placement on anxiety and stress. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Relaxing music as pre-medication before surgery: a randomised controlled trial. [2022]

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

Music proves therapeutic to pain levels. [2019]

13. Denmark pubmed.ncbi.nlm.nih.gov

[Investigation of perioperative musical preferences during elective surgery]. [2019]