NCT05610969

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

To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Music	patients in this group will receive self-selected music after the golden moment has been completed between the patient, provider, and nursing staff
DRUG	Midazolam	patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2022-11-09
• Last updated: 2025-05-14
• Results posted: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study