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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
Study Summary
This trial investigates the effects of music interventions on anxiety and pain in adult populations undergoing diverse types of minor surgery. The results indicate that music therapy significantly reduces both postoperative anxiety and pain.
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.Check my eligibility
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.See study design
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 ~ baseline, pre-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of music therapy on reducing post-operative opioid requirement
Secondary outcome measures
Change in post-operative pain using a numerical rating scale
Incidence of post-operative nausea and vomiting (PONV)
Length of hospital stay
+7 moreTrial 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
1,726 Previous Clinical Trials
16,305,663 Total Patients Enrolled
4 Trials studying Postoperative Pain
430 Patients Enrolled for Postoperative Pain
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the conditions to partake in this medical research study?
"The criteria for entry into this clinical trial entails having an anxiety disorder and being within the 18-70 years old range. Altogether, 80 patients are needed to complete this research project."
Answered by AI
Does this trial welcome participants who have attained the age of majority?
"This clinical trial only allows applicants aged 18 to 70. Alternatively, there are 225 trials for minors and 890 studies specifically geared towards senior citizens."
Answered by AI
How many participants have been enlisted in this clinical trial?
"Indeed, clinicaltrials.gov stipulates that this trial is actively recruiting participants as of the present day. First posted on May 5th 2022 and last updated on 23rd of the same month, 80 individuals are needed to be enrolled at 1 site."
Answered by AI
Is recruitment for this study open at the present time?
"The data available on clinicaltrials.gov suggests that this medical experiment is actively recruiting participants, having been initially posted to the website on May 5th 2022 and edited most recently on May 23rd 2022."
Answered by AI
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