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

NCT ID: NCT05610969

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-05-08

Brief Summary

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

Detailed Description

Preoperative anxiety is common and can adversely affect a patient's perioperative course by elevating stress markers, promoting fluctuations in hemodynamics and negatively impacting on postoperative recovery. Preoperative anxiety is routinely treated with pharmacologic agents such as midazolam, a benzodiazepine, which has known, undesirable side effects including respiratory depression, hemodynamic perturbations, and paradoxical effects such as hostility, aggression, and psychomotor agitation. The use of sedative medications requires continuous vital sign monitoring of patients by either anesthesia or nursing personnel and there is a question of whether midazolam helps reduce pre-procedural anxiety compared with placebo. Music is a non-pharmacologic intervention that has been shown to significantly decrease preoperative anxiety. This intervention can be used as an adjunct or even replace pharmacologic agents to help with preoperative anxiety. Music is a modality that is virtually harm-free and relatively cheap in cost. Patients who are unable to tolerate pharmacologic agents to treat preoperative anxiety can greatly benefit from non-pharmacologic options such as music.

Regional anesthesia procedures such as an ultrasound guided, peripheral nerve block is a common bedside procedure done preoperatively. Patients may have some anxiety prior to the administration of this nerve block procedure and may receive sedation for it. However, it is imperative not to over sedate them as constant feedback from the patient is necessary during the procedure. Commonly, midazolam is used to reduce this anxiety, but non-pharmacologic therapies can also reduce anxiety. In our recent published study, we evaluated the use of research-selected, relaxing music, to reduce anxiety before the nerve block is administered. In this study, we used noise-canceling headphones and played research-selected music as our anxiolytic music modality and compared this with midazolam. The findings showed no difference between both groups in the change in anxiety scores from after to before the nerve block, however patients had better satisfaction in the midazolam group and increased difficulty in communication in the music group. We attributed this to not allowing patients to choose their own selection of music and the use of noise-canceling headphones.

Therefore, in this follow-up study, we aim to evaluate the use of patient-selected music via non-noise canceling headphones as a preoperative anxiolytic prior to the administration of a bedside, peripheral nerve block procedure. This study will be conducted at an ambulatory surgical center in a university setting.

Conditions

Peripheral Nerve Block; Anxiety; Preoperative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music group

self-selected music

Group Type: ACTIVE_COMPARATOR

Music

Intervention Type: OTHER

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

Midazolam group

IV midazolam (1mg to 2mg max)

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

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

Interventions

Music

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

Intervention Type: OTHER

Midazolam

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

Intervention Type: DRUG

Other Intervention Names

Hypnovel; Versed

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Veena Graff

Assistant Professor of Anesthesiology & Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veena Graff, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Anesthesiology and Critical Care

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

842519

Identifier Type: -

Identifier Source: org_study_id