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Music Therapy for Perioperative Anxiety and Pain
N/A
Waitlist Available
Led By Shiv K Goel, MD, PhD, MBA
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 3, 4, and 5 post-operative
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates the use of music therapy to reduce anxiety and pain in adults aged 18-70 undergoing minor surgeries. Patients will listen to calming music at different stages of their surgery. The goal is to help them feel more relaxed and comfortable, reducing the need for traditional pain management methods that can have side effects. Music therapy has been widely studied and shown to reduce anxiety and pain in various medical procedures, including surgeries.
Who is the study for?
This trial is for adults aged 18-70 who are scheduled for same-day surgery under general anesthesia with a nerve block, such as breast surgery or laparoscopic procedures. They should be in good to moderate health (ASA I-III) and have mild to moderate pre-surgery anxiety levels.
What is being tested?
The study tests the effects of music therapy on reducing anxiety and pain after minor surgeries compared to standard care. It aims to see if patients using music therapy feel less anxious or in pain, which could help them leave the hospital sooner.
What are the potential side effects?
Music therapy is generally safe but may not suit everyone's preferences or cultural beliefs. Unlike medications, it doesn't cause physical side effects but might not provide enough relief for some individuals' anxiety or pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 2, 3, 4, and 5 post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 2, 3, 4, and 5 post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of music therapy on reducing post-operative opioid requirement
Secondary study objectives
Change in post-operative pain using a numerical rating scale
Incidence of post-operative nausea and vomiting (PONV)
Length of hospital stay
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Music therapy + Standard of Care Enhanced Recovery After Surgery (ERAS)Experimental Treatment2 Interventions
All participants will have complete Enhanced Recovery After Surgery (ERAS) standard of care. A preoperative music intervention will be played first in the preoperative holding area, a second music intervention played immediately following the induction of anesthesia in the operating room, and a third music intervention played in the recovery room when the patient is awake and responsive.
Group II: Standard of Care Enhanced Recovery After Surgery (ERAS)Active Control1 Intervention
Participants randomized into the control group will receive complete Enhanced Recovery After Surgery (ERAS) standard of care and no music therapy sessions.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,906 Total Patients Enrolled
25 Trials studying Anxiety
12,903 Patients Enrolled for Anxiety
Shadyside Hospital FoundationUNKNOWN
2 Previous Clinical Trials
42 Total Patients Enrolled
Shiv K Goel, MD, PhD, MBAPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very serious medical condition.Your anxiety score is not too low or too high on the baseline test.You are between 18 and 70 years old and have a certain level of health according to the American Society of Anesthesiologists.You are regularly using opioids.You are already using a different treatment for anxiety or pain, like aromatherapy or hypnosis.Listening to any music other than the specific one planned for the operating room is not allowed.You are scheduled to have spinal anesthesia.You have significant mental health issues.You have a history of using drugs or drinking too much alcohol.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.