Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks

NCT05610969 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 842519
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating music vs midazolam as a means of anxiolysis for preoperative single-shot nerve block placement.

Conditions

Peripheral Nerve Block; Anxiety; Preoperative Anxiety

Keywords

Midazolam; Adjuvants, Anesthesia; Anti-Anxiety Agents; Hypnotics and Sedatives; Tranquilizing Agents; Anesthetics; GABA Modulators; GABA Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Neurotransmitter Agents

Outcome Measures

Primary Outcomes (1)

• Change in STAI-6 Scores From Post to Pre

  Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.

  1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)

Secondary Outcomes (4)

• Patient Satisfaction Scores of the Experience During Procedure

  immediately after nerve block placement (less than 1 minute after)

• Provider Satisfaction Scores of the Experience During Procedure

  immediately after nerve block placement (less than 1 minute after)

• Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider

  immediately after nerve block placement (less than 1 minute after)

• Block Times - Time it Took to do the Block

  start of doing the block to immediately after nerve block placement, less than 1 minute after

Study Arms (2)

Music group

ACTIVE COMPARATOR

self-selected music

Other: Music

Midazolam group

ACTIVE COMPARATOR

IV midazolam (1mg to 2mg max)

Drug: Midazolam

Interventions

Music OTHER

patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff

Music group

Midazolam DRUG

patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Also known as: Hypnovel, Versed

Midazolam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are \>18 years of age
• Patients able to give informed consent in receiving a peripheral nerve block in the preoperative bay for their primary anesthetic and/or for their postoperative pain control

You may not qualify if:

• significant psychiatric disorder such as generalized anxiety disorder, panic disorder, depression, psychosis, bipolar disorder
• individuals who were incompetent to give informed consent
• pregnant and/or breast-feeding patients
• any underlying coagulopathy
• infection or other factors which would be a contraindication to receiving a peripheral nerve block
• hypersensitivity to midazolam
• history of renal impairment.
• Patients who were extremely anxious (scores greater than 50 on the State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy; Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Veena Graff MD, MS
• Organization: University of Pennsylvania

veena.graff@pennmedicine.upenn.edu

(215) 662-8244

Study Officials

• Veena Graff, MD, MS

  University of Pennsylvania, Anesthesiology and Critical Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology & Critical Care

Model Details: 1:1

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: November 9, 2022
• Study Start: September 1, 2021
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)