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Benzodiazepine

Music group for 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

Study 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.Check my eligibility
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.See study design
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 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after) 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 STAI-6 Scores From Post to Pre
Anxiety
Secondary outcome measures
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 more

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
2,005 Previous Clinical Trials
42,882,073 Total Patients Enrolled
22 Trials studying Anxiety
12,850 Patients Enrolled for Anxiety
Veena Graff, MD, MSPrincipal InvestigatorUniversity of Pennsylvania, Anesthesiology and Critical Care
1 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Anxiety
160 Patients Enrolled for Anxiety

Media Library

Midazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05610969 — Phase 1 & 2
Anxiety Research Study Groups: Music group, Midazolam group
Anxiety Clinical Trial 2023: Midazolam Highlights & Side Effects. Trial Name: NCT05610969 — Phase 1 & 2
Midazolam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610969 — Phase 1 & 2
Anxiety Patient Testimony for trial: Trial Name: NCT05610969 — Phase 1 & 2

Frequently Asked Questions

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

Are new patients being accepted into the program at this time?

"This study is currently recruiting participants, according to clinicaltrials.gov. The trial was initially posted on 9/1/2021 and was most recently edited on 11/3/2022."

Answered by AI

What are the milestones of this clinical trial?

"The primary objective of this study is to measure the change in STAI-6 scores from pre- to post-nerve block placement, which will take place over approximately 1-2 minutes. Secondary outcomes include patient and provider satisfaction scores of the experience during the procedure (on a 10-point numeric rating scale, with higher numbers indicating higher satisfaction), and an evaluation of difficulties in communication between provider and patient (on a 5-point Likert scale, with higher numbers indicating more difficulty communicating)."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried dozens of meds, I’m really looking for some anxiety relief.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks
Veena Graff 2021. "Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610969.
~22 spots leftby Sep 2024
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