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

Primary Purpose

Peripheral Nerve Block, Anxiety, Preoperative Anxiety

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Music
Midazolam
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Block focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Music group

Midazolam group

Arm Description

self-selected music

IV midazolam (1mg to 2mg max)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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
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.
Block Times - time it took to do the block
differences amongst music and midazolam group

Full Information

First Posted
August 5, 2022
Last Updated
November 3, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05610969
Brief Title
Music vs Midazolam During Preop Nerve Block Placement - Part 2 Study On Anxiolytic Options Before Peripheral Nerve Blocks
Official Title
To Serenade or To Sedate? That is Still The Question - A Followup Trial On Anxiolytic Options Before Peripheral Nerve Blocks
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music group
Arm Type
Active Comparator
Arm Description
self-selected music
Arm Title
Midazolam group
Arm Type
Active Comparator
Arm Description
IV midazolam (1mg to 2mg max)
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
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
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Hypnovel, Versed
Intervention Description
patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
Primary Outcome Measure Information:
Title
Clinical Anxiety Levels
Description
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Time Frame
1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Title
Change in STAI-6 Scores From Post to Pre
Description
Spielberger State-Trait Anxiety Inventory 6 Scale range is from 20 to 80. Higher the score, the higher the anxiety level is.
Time Frame
1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)
Secondary Outcome Measure Information:
Title
Patient Satisfaction Scores of the Experience During Procedure
Description
Survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Time Frame
immediately after nerve block placement (less than 1 minute after)
Title
Provider Satisfaction Scores of the Experience During Procedure
Description
survey which assess satisfaction on a 10-point numeric rating scale Scale ranges from 0 to 10. A higher number indicates a higher satisfaction
Time Frame
immediately after nerve block placement (less than 1 minute after)
Title
Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider
Description
surveyed on a 5-point Likert scale Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate.
Time Frame
immediately after nerve block placement (less than 1 minute after)
Title
Block Times - time it took to do the block
Description
differences amongst music and midazolam group
Time Frame
immediately after nerve block placement (less than 1 minute after)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veena Graff, MD, MS
Phone
2156628244
Email
Veena.Graff@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio Badiola, MD
Phone
2156628244
Email
ignacio.badiola@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veena Graff, MD, MS
Organizational Affiliation
University of Pennsylvania, Anesthesiology and Critical Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veena Graff, MD, MS
Email
veena.graff@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Keaton I Pendergrast, BS
Email
keaton.pendergrast@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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