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Benzodiazepine
Music vs Midazolam for Pre-Surgery Anxiety
Phase 1 & 2
Recruiting
Led By Veena Graff, MD, MS
Research Sponsored by University of Pennsylvania
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 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Awards & highlights
No Placebo-Only Group
Summary
This trial compares music to a drug to reduce pre-surgery anxiety before a nerve block.
Who is the study for?
This trial is for adults over 18 who can consent to receiving a nerve block before surgery for anesthesia or pain control. It's not for those allergic to midazolam, with severe psychiatric conditions, extreme anxiety (STAI-6 score >50), kidney issues, pregnant/breastfeeding women, or coagulation disorders.
What is being tested?
The study compares the effects of listening to music versus taking midazolam on reducing anxiety before getting a single-shot nerve block as preparation for surgery.
What are the potential side effects?
Midazolam may cause drowsiness, light-headedness, confusion, blurred vision and nausea. Music has no known side effects but might not be effective in reducing anxiety for everyone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in STAI-6 Scores From Post to Pre
Anxiety
Secondary study objectives
Block Times - time it took to do the block
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
Patient Satisfaction Scores of the Experience During Procedure
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Music groupActive Control1 Intervention
self-selected music
Group II: Midazolam groupActive Control1 Intervention
IV midazolam (1mg to 2mg max)
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,373 Total Patients Enrolled
Veena Graff, MD, MSPrincipal InvestigatorUniversity of Pennsylvania, Anesthesiology and Critical Care
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and agree to the study's requirements.I am older than 18 years.I have a blood clotting disorder.I have had kidney problems in the past.I do not have infections or conditions that prevent me from getting a nerve block.I agree to receive a nerve block for surgery pain management.
Research Study Groups:
This trial has the following groups:- Group 1: Music group
- Group 2: Midazolam group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Botox Patient Testimony for trial: Trial Name: NCT05610969 — Phase 1 & 2