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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610969
• Other study ID #: 842519
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: Veena Graff, MD, MS
• Phone: 2156628244
• Email: Veena.Graff[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Peripheral Nerve Block
• Preoperative Anxiety

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Anxiety Levels	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)
Primary	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	Patient Satisfaction Scores of the Experience During Procedure	Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction	immediately after nerve block placement (less than 1 minute after)
Secondary	Provider Satisfaction Scores of the Experience During Procedure	survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction	immediately after nerve block placement (less than 1 minute after)
Secondary	Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider	surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.	immediately after nerve block placement (less than 1 minute after)
Secondary	Block Times - time it took to do the block	differences amongst music and midazolam group	immediately after nerve block placement (less than 1 minute after)