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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
Awards & highlights

Study Summary

This trial will study the effects of music on stress levels during anesthesia induction.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Heart Rate from baseline recorded when the headphones are placed on the patient
Secondary outcome measures
Change in Blood Pressure from baseline recorded when the headphones are placed on the patient
Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient

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.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
491 Previous Clinical Trials
2,798,593 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies open to volunteers for this clinical research?

"Affirmative. Clinicaltrials.gov attests that this research project, which was originally posted on January 1st 2017, is still looking for volunteers. The investigators must find 212 participants from a single location."

Answered by AI

How many participants are currently enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this research study is currently being conducted and first opened recruitment on January 1st 2017. It was last modified on July 12th 2022 and requires 212 patients from one single location."

Answered by AI

Am I qualified to partake in this clinical investigation?

"This clinical trial, which is seeking to recruit 212 individuals, requires that candidates have pediatric pre-operative stress and are between 10 and 16 years old."

Answered by AI

Is it possible for individuals aged 50 and above to participate in this investigation?

"This trial is open to children aged between 10 and 16 years old."

Answered by AI
~18 spots leftby Dec 2024